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Sample records for stent diabedes randomized

  1. Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients the randomized diabetes and drug-eluting stent (DiabeDES) IV intravascular ultrasound trial

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Maeng, Michael; Thayssen, Per

    2013-01-01

    OBJECTIVE: To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients. BACKGROUND: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent...... implantation due to intimal hyperplasia (IH). METHODS: In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available...... in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume. RESULTS: Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0...

  2. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial

    DEFF Research Database (Denmark)

    Maeng, Michael; Jensen, Lisette Okkels; Galloe, Anders Michael

    2008-01-01

    group (0.23 +/- 0.54 vs 0.44 +/- 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.......8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite...

  3. Late lumen loss and intima hyperplasia after sirolimus-eluting and zotarolimus-eluting stent implantation in diabetic patients: the diabetes and drug-eluting stent (DiabeDES III) angiography and intravascular ultrasound trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Mæng, Michael; Thayssen, Per

    2011-01-01

    Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use quantitative coronary angiography (QCA) and volumetric intravascular ultrasound (IVUS) to evaluate the effects...... of the sirolimus-eluting Cypher® stent (SES) and the zotarolimus-eluting Endeavor® stent (ZES) on angiographic late lumen loss and intima hyperplasia in diabetic patients....

  4. Stent

    Science.gov (United States)

    ... Drugs & Supplements Videos & Tools Español You Are Here: Home → Medical Encyclopedia → Stent URL of this page: //medlineplus.gov/ency/article/002303.htm Stent To use the sharing features on this page, please enable JavaScript. A stent is a tiny tube placed into a hollow structure in your ...

  5. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis.

    Science.gov (United States)

    Haapamäki, Carola; Kylänpää, Leena; Udd, Marianne; Lindström, Outi; Grönroos, Juha; Saarela, Arto; Mustonen, Harri; Halttunen, Jorma

    2015-07-01

    The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis. This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6 months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal. Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1 - 66 months). The 2-year, stricture-free success rate was 90 % (95 % confidence interval [CI] 72 % - 97 %) in the plastic stent group and 92 % (95 %CI 70 % - 98 %) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000). A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis.Study registered at ClinicalTrials.gov (NCT01085747). © Georg Thieme Verlag KG Stuttgart · New York.

  6. Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

    Science.gov (United States)

    Lemos, Pedro A; Abizaid, Alexandre A C; Meireles, George C; Sarmento-Leite, Rogério; Prudente, Mauricio; Cantarelli, Marcelo; Dourado, Adriano D; Mariani, Jose; Perin, Marco A; Costantini, Costantino; Costa, Ricardo A; Costa, José Ribamar; Chamie, Daniel; Campos, Carlos A; Ribeiro, Expedito

    2015-12-01

    To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent. © 2015 John Wiley & Sons Ltd.

  7. Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

    Science.gov (United States)

    Schmidt, Arthur; Riecken, Bettina; Rische, Susanne; Klinger, Christoph; Jakobs, Ralf; Bechtler, Matthias; Kähler, Georg; Dormann, Arno; Caca, Karel

    2015-05-01

    Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634). © Georg Thieme Verlag KG Stuttgart · New York.

  8. Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

    Science.gov (United States)

    Philip, Femi; Stewart, Susan; Southard, Jeffrey A

    2016-07-01

    The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared. Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years. Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  9. Percutaneous Palliation of Pancreatic Head Cancer: Randomized Comparison of ePTFE/FEP–Covered Versus Uncovered Nitinol Biliary Stents

    International Nuclear Information System (INIS)

    Krokidis, Miltiadis; Fanelli, Fabrizio; Orgera, Gianluigi; Tsetis, Dimitrios; Mouzas, Ioannis; Bezzi, Mario; Kouroumalis, Elias; Pasariello, Roberto; Hatzidakis, Adam

    2011-01-01

    The purpose of this study was to compare the clinical effectiveness of expanded polytetrafluoroethylene/fluorinated-ethylene-propylene (ePTFE/FEP)–covered stents with that of uncovered nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer. Eighty patients were enrolled in a prospective randomized study. Bare nitinol stents were used in half of the patients, and ePTFE/FEP–covered stents were used in the remaining patients. Patency, survival, complications, and mean cost were calculated in both groups. Mean patency was 166.0 ± 13.11 days for the bare-stent group and 234.0 ± 20.87 days for the covered-stent group (p = 0.007). Primary patency rates at 3, 6, and 12 months were 77.5, 69.8, and 69.8% for the bare-stent group and 97.5, 92.2, and 87.6% for the covered-stent group, respectively. Mean secondary patency was 123.7 ± 22.5 days for the bare-stent group and 130.3 ± 21.4 days for the covered-stent group. Tumour ingrowth occurred exclusively in the bare-stent group in 27.5% of cases (p = 0.002). Median survival was 203.2 ± 11.8 days for the bare-stent group and 247.0 ± 20 days for the covered-stent group (p = 0.06). Complications and mean cost were similar in both groups. Regarding primary patency and ingrowth rate, ePTFE/FEP–covered stents have shown to be significantly superior to bare nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer and pose comparable cost and complications. Use of a covered stent does not significantly influence overall survival rate; nevertheless, the covered endoprosthesis seems to offer result in fewer reinterventions and better quality of patient life.

  10. Combined-stent covered technique and single covered stent technique for transjugular intrahepatic porto-systemic shunt: a prospective randomized controlled study

    International Nuclear Information System (INIS)

    Wang Changming; Li Xuan; Fu Jun; Lu Xianjun; Luan Jingyuan; Li Tianrun; Zhao Jun; Dong Guoxiang

    2014-01-01

    Objective: To compare the technique of combined stents with that of single stent-graft for the construction of transjugular intrahepatic porto-systemic shunt (TIPS) and to discuss their clinical outcomes. Methods: During the period from April 2011 to Dec. 2012, a total of 30 patients with upper gastrointestinal bleeding due to portal hypertension were admitted to the hospital. TIPS procedure was carried out in all the 30 patients. The patients were randomly allocated into either combined-stent group (n=17) or stent-graft group (control group, n=13) on the basis of a computer-generated randomization sequence. The PSC quality control, the patency rate of portal vein branches and the shunts, the incidence of encephalopathy and the survival rate of the two groups were documented and analyzed. Results: Technical success rate was 100%. After the treatment, in both groups the PSG became significantly lower than the PSG determined before the treatment (P<0.000). According to quality control chart, the of combined stents was superior to stent-graft technique in effectively controlling PSG. Five days after TIPS, the ammonia level in the combined- stent group was significantly decreased (P=0.029), while in the control group the ammonia level showed no significant changes (P=0.065). One patient died shortly after TIPS. The median follow- up time was 181 days. During the follow-up period death occurred in 3 cases in each group. The difference in the survival rate between the two groups was no significant (P=0.906). Of the three patients who developed encephalopathy, two were in the combined-stent group and one was in the control group. After medication the symptoms of encephalopathy were relieved. The patency rate of the shunts was 100% and the re-bleeding rate was 0% for both groups. The patency rate of portal vein branches was significantly higher in the combined-stent group than that in the control group (P=0.039). Conclusion: For the construction of TIPS, the technique of

  11. A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis

    Science.gov (United States)

    Qureshi, Adnan I; Chaudhry, Saqib A; Siddiq, Farhan; Majidi, Shahram; Rodriguez, Gustavo J; Suri, M Fareed K

    2013-01-01

    Background: Both primary angioplasty alone and angioplasty with a self-expanding stent have been compared in non-randomized concurrent clinical studies that suggest equivalent results. However, there is no randomized trial that has compared the two procedures in patients with symptomatic high grade intracranial stenosis. Objective: The primary aim of the randomized trial was to compare the clinical and angiographic efficacy of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke, requirement for second treatment, and death in patients with symptomatic intracranial stenosis. Methods: The study prospectively evaluated efficacy and safety of the two existing neurointerventional techniques for treatment of moderate intracranial stenosis (stenosis ≥ 50%) with documented failure of medical treatment or severe stenosis (≥70%) with or without failure of medical treatment. Results: A total of 18 patients were recruited in the study (mean age [±SD] was 64.7 ± 15.1 years); out of these, 12 were men. Of these 18, 10 were treated with primary angioplasty and 8 were treated with angioplasty followed by self-expanding stent. The technical success rates of intracranial angioplasty and stent placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients, respectively. The total fluoroscopic time (mean [±SD]) was lower in patients undergoing primary angioplasty 37 [±11] min versus those undergoing angioplasty followed by self-expanding stent 42 [±15] min, P = 0.4321. The stroke and death rate within 1 month was very low in both patient groups (1 of 10 versus 0 of 8 patients). One patient randomized to stent placement continued to have recurrent ischemic symptoms requiring another angioplasty in the vertebral artery on post-procedure Day 2. Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty

  12. A randomized controlled trial comparing alpha blocker (tamsulosin) and anticholinergic (solifenacin) in treatment of ureteral stent-related symptoms.

    Science.gov (United States)

    El-Nahas, Ahmed R; Tharwat, Mohamed; Elsaadany, Mohamed; Mosbah, Ahmed; Gaballah, Mohamed A

    2016-07-01

    To compare the effectiveness of tamsulosin and solifenacin in relieving ureteral stents related symptoms. A randomized controlled trial was conducted between January 2013 and July 2014. Inclusion criteria were patients aged 20-50 years who underwent temporary unilateral ureteral stent for drainage of calcular upper tract obstruction or after ureteroscopic lithotripsy. Patients with history of lower urinary tract symptoms before stent placement, stents that were fixed after open or laparoscopic procedures, and those who developed complications related to the primary procedure were not included. Eligible patients were randomly assigned to 1 of 3 groups using computer-generated random tables. Patients in group 1 received placebo, patients in group 2 received tamsulosin 0.4 mg once daily, and those in group 3 received solifenacin 5 mg once daily. Ureteral Stent Symptom Questionnaire (USSQ) was answered by all patients 1-2 weeks after stent placement. The primary outcome was the comparison of total score of USSQ between all groups. The study included 131 patients. All baseline characteristics (age, sex, side, indication, length, and duration of stent) were comparable for all groups. Total USSQ score was 61 in solifenacin group, 76 in tamsulosin group, and 83 in control group (P tamsulosin group (P tamsulosin alone or solifenacin alone in patients with ureteral stents can improve the quality of life by decreasing ureteral stent-related symptoms. Solifenacin was better than tamsulosin. CLINICALTRIAL. NCT01880619.

  13. Doxazosin oral intake therapy to relieve stent - related urinary symptoms and pain: a prospective, randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Long Zhang

    Full Text Available ABSTRACT Objective: To assess the impact of Doxazosin Oral Intake Therapy on urinary symptoms and pain in patients with indwelling ureteral stents Patients and Methods: A total of 239 patients with ureteral stone-related hydronephrosis who underwent a double-J stent insertion after ureteroscopic lithotripsy were enrolled. Patients were randomized to receive doxazosin cotrolled release 4 mg once daily for 4 weeks or matching placebo. Patients completed the brief-form Chinese version Ureteric Stent Symptom Questionnaire (USSQ and quality of life (QoL score 2 weeks and 4 weeks after stent placement and 4 weeks after stent withdrawal. The analgesic use was also recorded during the stenting period. Results: Patients in Doxazosin Oral Intake Therapy group, in the first 2 weeks and second 2 weeks with the stent in situ, expressed significant lower daytime frequency (p=0.028 and p=0.038, nocturia (p=0.021 and p=0.008 and urgency (p=0.012 and p=0.014, respectively. Similarly, flank pain score, QoL score and analgesic use were also significant less in the stenting period. There was no significant difference in scores of urinary symptoms, pain and QoL during the post-stent period between two cohorts. Conclusions: Doxazosin Oral Intake Therapy reduced stent-related urinary symptoms, pain and the negative impact on QoL.

  14. A randomized multicenter comparison of hybrid sirolimus-eluting stents with bioresorbable polymer versus everolimus-eluting stents with durable polymer in total coronary occlusion: rationale and design of the Primary Stenting of Occluded Native Coronary Arteries IV study

    Directory of Open Access Journals (Sweden)

    Teeuwen Koen

    2012-12-01

    Full Text Available Abstract Background Percutaneous recanalization of total coronary occlusion (TCO was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST with drug-eluting stents (DES for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO. Methods/Design The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence

  15. Efficacy of tamsulosin hydrochloride in relieving "double-J ureteral stent-related morbidity": a randomized placebo controlled clinical study.

    Science.gov (United States)

    Singh, Iqbal; Tripathy, Sambit; Agrawal, Vivek

    2014-12-01

    To evaluate the efficacy of tamsulosin therapy in reducing ureteral double-J stent morbidity by evaluating USSQ, IPSS, QOL and VAS (primary objective) and to evaluate the morbidity and or complication(s) associated with indwelling double-J ureteral stent(s) and to evaluate the safety of tamsulosin therapy for "morbidity associated with double-J stents" by evaluating its tolerability, side effects and adverse events if any (secondary objective) as per protocol. After institutional review board approval, 60 consecutive patients with a double-J ureteral stent inserted after percutaneous nephrolithotomy or ureteroscopic stone treatment were randomly assigned to receive tamsulosin 0.4 mg, or a placebo for 4 weeks. The validated USSQ, VAS and IPSS were completed before stent insertion, at 3 days and 4 weeks after stent insertion and at 2 weeks after stent removal. Data were statistically analyzed for efficacy and tolerability of one drug over the other using Wilcoxon signed-rank test, Mann-Whitney test and Student's t test. Patients receiving tamsulosin compared with the placebo showed significant decrease in urinary index score, pain index score, work performance score, VAS score at loin area, VAS score at flank, VAS score at suprapubic area, average VAS score, need for antibiotics, number of hospital visits (P tamsulosin but, however, the decrease was not significant. No patients discontinued medication because of side effects. We conclude that ureteral stenting using double-J stents with concomitant tamsulosin therapy was generally well tolerated, safe, effective and significantly beneficial in reducing stent morbidity in the majority of our patients. We advocate the routine use of concomitant tamsulosin therapy in eligible patients undergoing ureteral stenting in order to minimize stent morbidity.

  16. Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH).

    Science.gov (United States)

    Ott, Ilka; Cassese, Salvatore; Groha, Philipp; Steppich, Birgit; Hadamitzky, Martin; Ibrahim, Tareq; Kufner, Sebastian; Dewitz, Karl; Hiendlmayer, Regina; Laugwitz, Karl-Ludwig; Schunkert, Heribert; Kastrati, Adnan; Fusaro, Massimiliano

    2017-06-06

    Atherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain. One hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months. Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%, P =0.009) or DA (55±29%, P =0.007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA. Clinical follow-up at 24 months revealed a lower risk for target lesion revascularization after PEB angioplasty and stenting as compared with BA and stenting or DA. We found no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation. Treatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion

  17. Covered Metallic Stents With an Anti-Migration Design vs. Uncovered Stents for the Palliation of Malignant Gastric Outlet Obstruction: A Multicenter, Randomized Trial

    Science.gov (United States)

    Lee, Hyuk; Min, Byung-Hoon; Lee, Jeong Hoon; Shin, Cheol Min; Kim, Younjoo; Chung, Hyunsoo; Lee, Sang Hyub

    2015-01-01

    OBJECTIVES: Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO. METHODS: A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement. RESULTS: At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency. CONCLUSIONS: WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer. PMID:26372507

  18. Drug-eluting stents for acute coronary syndrome: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Lishan Wang

    Full Text Available Drug-eluting stents (DES are increasingly used for treatment of acute coronary syndrome (ACS. However, clinical efficacy and safety of various types of DES is not well established in these subjects. We therefore evaluated clinical utility of second-generation and first-generation DES in patients with ACS by conducting a meta-analysis.A search of Medline, Embase, the Cochrane databases, and Web of Science was made. Randomized controlled trials (RCTs which compared second-generation DES (everolimus-eluting stents [EES] or zotarolimus-eluting stents [ZES] versus first-generation DES (sirolimus-eluting stents [SES] or paclitaxe-eluting stents [PES] in patients with ACS and provided data on clinical efficacy or safety endpoints were included. Pooled estimates were calculated using random-effects model.A total of 2,757 participants with ACS in 6 RCTs were included. Compared with first-generation one, second-generation DES trended to be associated with the decreased incidence of definite or probable stent thrombosis in ACS patients (risk ratio [RR]  = 0.60, 95% confidence intervals [CI] 0.33 to 1.07, p = 0.09. However, the rate of target lesion revascularization (TLR significantly increased in second-generation DES (RR = 2.08, 95%CI 1.25 to 3.47, p = 0.005. There were no significant differences in the incidence of major adverse cardiac events (MACEs, all-cause death, cardiac death, and recurrent myocardial infarction between the two arms (all p>0.10. The second-generation EES showed a tendency towards lower risk of MACEs (p = 0.06 and a beneficial effect on reducing stent thrombosis episodes (p = 0.009, while the second-generation ZES presented an increased occurrence of MACEs (p = 0.02 and TLR (p = 0.003.Second-generation DES, especially EES, appeared to present a lower risk of stent thrombosis, whereas second-generation ZES might increase the need for repeat revascularization in ACS patients. During coronary

  19. Stenting or not prior to extracorporeal shockwave lithotripsy for ureteral stones? Results of a prospective randomized study.

    Science.gov (United States)

    Sfoungaristos, Stavros; Polimeros, Nikolaos; Kavouras, Adamantios; Perimenis, Petros

    2012-06-01

    To determine the need for pre-treatment stenting in patients undergoing extracorporeal shockwave lithotripsy (ESWL) for ureteral stones sized 4-10 mm. A prospective randomized study was conducted between September 2009 and March 2011. Included 156 patients randomized in stented and non-stented groups and underwent a maximum of 3 ESWL sessions. Radiographic follow-up was used to assess the stone fragmentation and clearance. Results were compared in terms of stone-free rates, post-treatment morbidity and complications. Overall efficacy was 76.9%. Stone-free rates were statistically significantly lower (P = 0.026) in the stented group (68.6%) compared to the non-stented ones (83.7%). Furthermore, stenting was significantly correlated with post-treatment lower urinary tract symptoms (P ≤ 0.001), need for more ESWL sessions (P = 0.019) and possibility for operation due to ESWL failure (P = 0.026). A multivariate analysis was conducted to identify the parameters which may predict complete stone removal after ESWL. Stone size (P = 0.026), stone location (P = 0.011) and stenting (P = 0.007) were the most significant factors. ESWL is an efficient and safe treatment for 4- to 10-mm ureteral stones. Pre-treatment stenting is limiting stone-free rates and is significantly influencing post-ESWL morbidity and quality of life in a negative manner, while it contributes minimally to the prophylaxis of complications.

  20. Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study.

    Science.gov (United States)

    Lim, Sun Gyo; Kim, Jin Hong; Lee, Kee Myung; Shin, Sung Jae; Kim, Chan Gyoo; Kim, Kyung Ho; Kim, Ho Gak; Yang, Chang Heon

    2014-07-01

    A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016). The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  1. Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Maeng, Michael

    2015-01-01

    BACKGROUND: Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide......-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population. DESIGN: The multicenter SORT OUT VII trial (NCT01879358...... will be used. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N...

  2. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent : 4-year results of the PROTECT randomized trial

    NARCIS (Netherlands)

    Wijns, William; Steg, Ph. Gabriel; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P.; Lipsic, Erik; Alamgir, Farqad; Rademaker-Havinga, Tessa; Boersma, Eric; Radke, Peter; van Leeuwen, Frank; Camenzind, Edoardo

    2014-01-01

    Aims To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable

  3. Randomized comparison between intracoronary β-radiation brachytherapy and implantation of paclitaxel-eluting stents for the treatment of diffuse in-stent restenosis

    International Nuclear Information System (INIS)

    Schukro, Christoph; Syeda, Bonni; Kirisits, Christian; Schmid, Rainer; Pichler, Philipp; Pokrajac, Boris; Lang, Irene; Poetter, Richard; Glogar, Dietmar

    2007-01-01

    Background and purpose: Intracoronary brachytherapy was the primary therapeutic option for the treatment of in-stent restenosis (ISR) during the last years. Especially for the treatment of diffuse ISR (lesions >10 mm), β-source brachytherapy was significantly superior to singular balloon angioplasty. Despite lacking clinical database, the implantation of drug eluting stents recently became a common procedure for the treatment of ISR. This randomized trial aimed to compare the efficacy of β-brachytherapy with β-radioisotopes 90 Sr/ 90 Y and paclitaxel-eluting stent implantation for the treatment of diffuse ISR. Material and methods: Thirty-seven patients with diffuse ISR were randomly assigned to β-brachytherapy after balloon angioplasty (Beta-Cath TM in 17 patients) or paclitaxel-eluting stent implantation (Taxus-Express2 TM in 20 patients). Six-month clinical follow-up was obtained for all patients, while angiographic follow-up was available for 30 patients. Results: Binary ISR (restenosis >50%) within target segment was observed in three patients treated with Beta-Cath TM , of which one needed target segment revascularisation for recurrent ISR, whereas no significant restenosis occurred in the patients treated with Taxus-Express2 TM (P = 0.037). No further major adverse cardiac (target segment revascularisation, myocardial infarction, death) was found in either group (P = NS). Stent implantation was the more time-saving (31 ± 11 min versus 60 ± 23 min, P TM arm, we found no difference in clinical outcome after implantation of paclitaxel-eluting stents for the treatment of diffuse ISR when compared to β-brachytherapy

  4. Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.

    Science.gov (United States)

    Choi, Woong Gil; Rha, Seung Woon; Choi, Cheol Ung; Kim, Eung Ju; Oh, Dong Joo; Cho, Yoon Hyung; Park, Sang Ho; Lee, Seung Jin; Hur, Ae Yong; Ko, Young Guk; Park, Sang Min; Kim, Ki Chang; Kim, Joo Han; Kim, Min Woong; Kim, Sang Min; Bae, Jang Ho; Bong, Jung Min; Kang, Won Yu; Seo, Jae Bin; Jung, Woo Yong; Cho, Jang Hyun; Kim, Do Hoi; Ahn, Ji Hoon; Kim, Soo Hyun; Jang, Ji Yong

    2016-06-25

    The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease. The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound. The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.

  5. Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study

    International Nuclear Information System (INIS)

    Chalmers, Nicholas; Walker, Paul T.; Belli, Anna-Maria; Thorpe, Anthony P.; Sidhu, Paul S.; Robinson, Graham; Ransbeeck, Mariella van; Fearn, Steven A.

    2013-01-01

    To determine whether primary stenting reduces the rate of restenosis compared with balloon angioplasty alone in the endovascular treatment of long superficial femoral artery lesions; and to assess the effect of treatment on quality of life. A total of 150 patients with superior femoral artery occlusion or severe stenosis of 5–22 cm length from 17 UK centers were randomized to either primary stenting with the SMART stent or balloon angioplasty (i.e., percutaneous transluminal angioplasty, PTA). Bailout stent placement was permitted in case of inadequate result from PTA. The primary end point was restenosis measured by duplex ultrasound at 1 year. Quality-of-life assessments were performed by the EuroQol (EQ)-5D questionnaire. Mean lesion length was 123.0 mm in the stent group and 116.8 mm in the PTA group. A total of 140 (93.3 %) of 150 had total occlusions. At 12 months’ follow-up, restenosis measured by Duplex ultrasound was not significantly different between the stent and PTA groups by intention-to-treat or as-treated analyses: 47.2 versus 43.5 % (p = 0.84) and 40.8 versus 46.7 % (p = 0.68), respectively. There were fewer target lesion revascularizations in patients randomized to stenting, but this did not reach statistical significance (12.5 vs. 20.8 %, p = 0.26). There was no difference in the rate of amputation. Patients in both groups reported improved quality of life. Primary stenting of long lesions in predominantly occluded superficial femoral arteries does not reduce the rate of binary restenosis compared with balloon angioplasty and bailout stenting. Both treatment strategies conferred a meaningful and sustained improvement to the quality of life of patients with severe superficial femoral artery disease.

  6. Preoperative Belladonna and Opium Suppository for Ureteral Stent Pain: A Randomized, Double-blinded, Placebo-controlled Study.

    Science.gov (United States)

    Lee, Franklin C; Holt, Sarah K; Hsi, Ryan S; Haynes, Brandon M; Harper, Jonathan D

    2017-02-01

    To investigate whether the use of a belladonna and opium (B&O) rectal suppository administered immediately before ureteroscopy (URS) and stent placement could reduce stent-related discomfort. A randomized, double-blinded, placebo-controlled study was performed from August 2013 to December 2014. Seventy-one subjects were enrolled and randomized to receive a B&O (15 mg/30 mg) or a placebo suppository after induction of general anesthesia immediately before URS and stent placement. Baseline urinary symptoms were assessed using the American Urological Association Symptom Score (AUASS). The Ureteral Stent Symptom Questionnaire and AUASS were completed on postoperative days (POD) 1, 3, and after stent removal. Analgesic use intraoperatively, in the recovery unit, and at home was recorded. Of the 71 subjects, 65 had treatment for ureteral (41%) and renal (61%) calculi, 4 for renal urothelial carcinoma, and 2 were excluded for no stent placed. By POD3, the B&O group reported a higher mean global quality of life (QOL) score (P = .04), a better mean quality of work score (P = .05), and less pain with urination (P = .03). The B&O group reported an improved AUASS QOL when comparing POD1 with post-stent removal (P = .04). There was no difference in analgesic use among groups (P = .67). There were no episodes of urinary retention. Age was associated with unplanned emergency visits (P <.00) and "high-pain" measure (P = .02) CONCLUSION: B&O suppository administered preoperatively improved QOL measures and reduced urinary-related pain after URS with stent. Younger age was associated with severe stent pain and unplanned hospital visits. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study

    Directory of Open Access Journals (Sweden)

    Scholten Pieter

    2007-07-01

    Full Text Available Abstract Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS. Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures

  8. Randomized comparison of sirolimus eluting, and biolimus eluting bioresorbable polymer stents

    DEFF Research Database (Denmark)

    Andreasen, Lene N; Holm, Niels R; Balleby, Ida R

    2018-01-01

    -inferiority (Δ = 0.60 mm2) of the Orsiro DES to the Nobori DES for the primary endpoint of mean extra stent lumen (ESL) i.e. vessel lumen outside the stent at 13-month follow-up. We randomized 124 patients to Orsiro (n = 60) or Nobori (n = 64). Due to a difference in the one-sided 95%-confidence interval of 0.......26 mm2, but increased to 0.82 mm2 after appropriate log-transformation, it could not be rejected that Orsiro exceeded the non-inferiority limit. Testing for superiority, Orsiro had a significantly larger mean ESL at follow-up (Orsiro: 0.11 mm2 [0.02;0.30] mm2, Nobori: 0.03 mm2 [0.00;0.17] mm2, P = 0.......04). Stent strut coverage was, Orsiro: 97.6 % [93.8;99.4]%, and Nobori: 96.3 % [90.5;98,6]% (P = 0.13). Conclusion: Orsiro DES had a significantly larger mean ESL at follow-up and it could not be excluded that Orsiro exceeded the limit for non-inferiority. Nobori DES had a more heterogeneous distribution...

  9. Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study.

    Science.gov (United States)

    Dellis, Athanasios E; Papatsoris, Athanasios G; Keeley, Francis X; Bamias, Aristotelis; Deliveliotis, Charalambos; Skolarikos, Andreas A

    2017-01-01

    To properly use the Ureteric Symptom Score Questionnaire (USSQ) to evaluate, in a randomized control study, the effect of tamsulosin, solifenacin, and their combination in improving symptoms and quality of life in patients with indwelling ureteral stents. After institutional review board approval, 260 patients with a ureteral stent were randomly assigned to receive tamsulosin 0.4 mg, solifenacin 5 mg, or placebo and further randomized to receive their combination. The validated USSQ was completed 1 and 4 weeks after stent insertion and 4 weeks after stent removal. Kruskal-Wallis test, chi-squared test (or Fisher's exact test), one-way analysis of variance, and T-test (or Wilcoxon rank-sum test if not normal data) were used for statistical analysis. The results were considered significant at p tamsulosin or solifenacin expressed significantly lower urinary (p tamsulosin and solifenacin alone or in combination, improves stent-related symptoms and has a positive impact on quality of life.

  10. Stent coverage and neointimal proliferation in bare metal stents postdilated with a Paclitaxel-eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up.

    Science.gov (United States)

    Poerner, Tudor C; Otto, Sylvia; Gassdorf, Johannes; Nitsche, Kristina; Janiak, Florian; Scheller, Bruno; Goebel, Björn; Jung, Christian; Figulla, Hans R

    2014-12-01

    In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the paclitaxel drug-eluting balloon (DEB) was compared with everolimus drug-eluting stents (DESs) at 6-month follow-up using optical coherence tomography. We hypothesized sufficient stent coverage at follow-up. A total of 105 lesions in 90 patients were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please DEB (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64±9.65% in BMS+DEB versus 4.93±9.29% in DES; P=0.366) were found. Thus, BMS+DEB achieved the prespecified noninferiority margin of 5% uncovered struts versus DES (difference between treatment means, 0.71%; one-sided upper 95% confidence interval, 4.14%; noninferiority P=0.04). Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+DEB group (15.7±7.8 versus 11.0±5.2 mm(3) proliferation volume/cm stent length; P=0.002). No significant focal in-stent stenosis analyzed with angiography (percentage diameter stenosis at follow-up, 22.8±11.9 versus 16.9±10.4; P=0.014) and optical coherence tomography (peak local area stenosis, 39.5±13.8% versus 36.8±15.6%; P=0.409) was found. Good stent strut coverage of >94% was found in both therapy groups. Despite greater suppression of global neointimal growth in DES, both DES and BMS+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up. http://www.clinicaltrials.gov. Unique identifier: NCT01056744. © 2014 American Heart Association, Inc.

  11. Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent with the sirolimus-eluting Orsiro stent in patients treated with percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Jakobsen, Lars; Christiansen, Evald H; Maeng, Michael

    2018-01-01

    Background: The Combo stent (OrbusNeich, Hoevelaken, the Netherlands) combining an abluminal, bioabsorbable polymer eluting sirolimus with a luminal CD34+ antibody to capture endothelial progenitor cells has been developed to further improve safety and efficacy of coronary interventions. We have...... designed a large-scale registry-based randomized clinical trial to compare the Combo stent to the Orsiro stent (Biotronik, Bülach, Switzerland) in patients undergoing percutaneous coronary intervention. Methods: The SORT OUT X study will randomly assign 3,140 patients to treatment with Combo or Orsiro...... stents at 3 sites in Western Denmark. Patients are eligible if they are ≥18 years old, have chronic stable coronary artery disease or acute coronary syndromes, and have ≥1 coronary lesion with >50% diameter stenosis requiring treatment with a drug-eluting stent. The primary end point target lesion...

  12. Dutch iliac stent trial : Long-term results in patients randomized for primary or selective stent placement

    NARCIS (Netherlands)

    Klein, W.M.; van der Graaf, Y.; Seegers, J.; Spithoven, J.H.; Buskens, E.; van Baal, J.G.; Buth, J.; Moll, F.L.; Overtoom, T.T.C.; van Sambeek, M.R.H.M.; Mali, W.P.T.M.

    Purpose: To determine long-term results of the prospective Dutch Iliac Stent Trial. Materials and Methods: The study protocol was approved by local institutional review boards. All patients gave written informed consent. Two hundred seventy-nine patients (201 men, 78 women; mean age, 58 years) with

  13. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent

    DEFF Research Database (Denmark)

    Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T

    2011-01-01

    We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI).......We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI)....

  14. A randomized study to compare bioactive titanium stents and everolimus-eluting stents in diabetic patients (TITANIC XV): 1-year results.

    Science.gov (United States)

    López-Mínguez, José R; Nogales-Asensio, Juan M; Doncel-Vecino, Luis J; Merchán-Herrera, Antonio; Pomar-Domingo, Francisco; Martínez-Romero, Pedro; Fernández-Díaz, José A; Valdesuso-Aguilar, Raúl; Moreu-Burgos, José; Díaz-Fernández, José

    2014-07-01

    Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  15. Meta-Analysis of Randomized Clinical Trials Comparing Biodegradable Polymer Drug-Eluting Stent to Second-Generation Durable Polymer Drug-Eluting Stents.

    Science.gov (United States)

    El-Hayek, Georges; Bangalore, Sripal; Casso Dominguez, Abel; Devireddy, Chandan; Jaber, Wissam; Kumar, Gautam; Mavromatis, Kreton; Tamis-Holland, Jacqueline; Samady, Habib

    2017-03-13

    The authors sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to second-generation durable polymer drug-eluting stents (DP-DES). Prior meta-analyses have established the superiority of BP-DES over bare-metal stents and first-generation DP-DES; however, their advantage compared with second-generation DP-DES remains controversial. The authors searched PubMed and Scopus databases for RCTs comparing BP-DES to the second-generation DP-DES. Outcomes included target vessel revascularization (TVR) as efficacy outcome and cardiac death, myocardial infarction (MI), and definite or probable stent thrombosis (ST) as safety outcomes. In addition, we performed landmark analysis for endpoints beyond 1 year of follow-up and a subgroup analysis based on the stent characteristics. The authors included 16 RCTs comprising 19,886 patients in the meta-analysis. At the longest available follow-up (mean duration 26 months), we observed no significant differences in TVR (p = 0.62), cardiac death (p = 0.46), MI (p = 0.98), or ST (risk ratio: 0.83, 95% confidence interval: 0.64 to 1.09; p = 0.19). Our landmark analysis showed that BP-DES were not associated with a reduction in the risk of very late ST (risk ratio: 0.87, 95% confidence interval: 0.49 to 1.53; p = 0.62). Similar outcomes were seen regardless of the eluting drug (biolimus vs. sirolimus), the stent platform (stainless steel vs. alloy), the kinetics of polymer degradation or drug release (6 months), the strut thickness of the BP-DES (thin 100 μm), or the DAPT duration (≥6 months vs. ≥12 months). BP-DES have similar safety and efficacy profiles to second-generation DP-DES. Published by Elsevier Inc.

  16. A randomized, controlled, multicenter trial to evaluate the safety and efficacy of Zotarolimus- vs. Paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries

    DEFF Research Database (Denmark)

    Chevalier, Bernard; Dimario, Carlo; Neumann, Franz-Josef

    2013-01-01

    The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the pr...

  17. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial.

    Science.gov (United States)

    Serruys, Patrick W; Farooq, Vasim; Kalesan, Bindu; de Vries, Ton; Buszman, Pawel; Linke, Axel; Ischinger, Thomas; Klauss, Volker; Eberli, Franz; Wijns, William; Morice, Marie Claude; Di Mario, Carlo; Corti, Roberto; Antoni, Diethmar; Sohn, Hae Y; Eerdmans, Pedro; Rademaker-Havinga, Tessa; van Es, Gerrit-Anne; Meier, Bernhard; Jüni, Peter; Windecker, Stephan

    2013-08-01

    This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority 1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  18. Results of a randomized clinical trial of external beam radiation to prevent restenosis after superficial femoral artery stenting.

    Science.gov (United States)

    Therasse, Eric; Donath, David; Elkouri, Stéphane; Lespérance, Jacques; Giroux, Marie-France; Oliva, Vincent L; Guertin, Marie-Claude; Bouchard, Louis; Perreault, Pierre; Gilbert, Patrick; Soulez, Gilles

    2016-06-01

    The objective of this study was to evaluate the safety and efficacy of external beam radiation (EBR) in preventing restenosis after superficial femoral artery (SFA) stenting in comparison with a control group treated with SFA stenting only. In this Institutional Review Board-approved study, patients who provided written informed consent were randomly assigned to 0 Gy or 14 Gy of EBR to the stent site 24 hours after SFA stenting. The primary end point was the angiographic binary restenosis rate 2 years after stenting. Categorical and continuous end points were respectively analyzed using logistic regression models and Wilcoxon tests. End points expressed as time to event were analyzed using a log-rank test. The study included 155 patients, 46 women and 109 men (mean age, 66 years; range, 45-85 years). In the 0 and 14 Gy groups, binary restenosis was present, respectively, in 44% (34/77) and 68% (52/76; P = .003) 2 years after stenting. Stent thrombosis occurred in 13% (10/78) of the 0 Gy group and in 33% (25/77) of the 14 Gy group (P = .003). Target lesion revascularization at 2 years was 26% (25/78) in the 0 Gy group and 30% (23/77) in the 14 Gy group (P = .56). There were no significant differences in total walking distances change from baseline to 2 years (46 ± 100 and 26 ± 79 m, respectively, in the 0 Gy and 14 Gy group; P = .25). There were no procedure-related deaths and no major amputations. A single 14 Gy dose of EBR to the SFA stenting site did not prevent in-stent restenosis. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

  19. 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents

    DEFF Research Database (Denmark)

    Galløe, Anders M; Kelbæk, Henning; Thuesen, Leif

    2017-01-01

    of patients included in a large randomized trial for 10 years to enable detection of late changes in annual event rates that could necessitate medical attention. METHODS: A total of 2,098 unselected all-comer patients (50% with acute coronary syndrome) were randomly assigned to have a first-generation DES...... for both stent types, with no apparent late changes. Although there is no need for extraordinary medical attention for these patients, the absence of declines in annual event rates calls for continuous surveillance. (Danish Organization on Randomized Trials With Clinical Outcome II [SORT OUT II]; NCT...

  20. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

    Science.gov (United States)

    Dippel, Eric J; Makam, Prakash; Kovach, Richard; George, Jon C; Patlola, Raghotham; Metzger, D Christopher; Mena-Hurtado, Carlos; Beasley, Robert; Soukas, Peter; Colon-Hernandez, Pedro J; Stark, Matthew A; Walker, Craig

    2015-01-01

    The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR). Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging. The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure. Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74). The EXCITE ISR trial is the first large, prospective, randomized study

  1. 3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

    Science.gov (United States)

    Alfonso, Fernando; Pérez-Vizcayno, María José; Cuesta, Javier; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José Ramón; Masotti, Mónica; Zueco, Javier; Cequier, Angel; Velázquez, Maite; Moreno, Raúl; Mainar, Vicente; Domínguez, Antonio; Moris, Cesar; Molina, Eduardo; Rivero, Fernando; Jiménez-Quevedo, Pilar; Gonzalo, Nieves; Fernández-Pérez, Cristina

    2018-05-28

    This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Treatment of patients with DES-ISR remains a challenge. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p 1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940). Published by Elsevier Inc.

  2. The OCT-ORION Study: A Randomized Optical Coherence Tomography Study Comparing Resolute Integrity to Biomatrix Drug-Eluting Stent on the Degree of Early Stent Healing and Late Lumen Loss.

    Science.gov (United States)

    Lee, Stephen W L; Tam, Frankie C C; Lam, Simon C C; Kong, Shun-Ling; Shea, Catherine P; Chan, Kelvin K W; Wong, Michael K L; Chan, Michael P H; Wong, Anthony Y T; Yung, Arthur S Y; Lam, Yui-Ming; Zhang, Lei-Wei; Wu, Karl K Y; Mintz, Gary S; Maehara, Akiko

    2018-04-01

    Durable polymers used in drug-eluting stents are considered a potential cause of hypersensitivity inflammatory response adversely affecting stent healing. Using a sequential follow-up with optical coherence tomography, we compared the differences in healing profiles of 2 drug-eluting stents with a biodegradable or durable polymer. Sixty patients with multivessel disease were prospectively enrolled to receive both study stents, which were randomly assigned to 2 individual vessels, a Resolute Integrity zotarolimus-eluting stent with a durable BioLinx polymer and a BioMatrix NeoFlex Biolimus A9-eluting stent with a biodegradable polylactic acid polymer. Optical coherence tomography was performed at baseline, then in 5 randomly assigned monthly groups at 2 to 6 months, and at 9 months in all patients. The primary end point was the difference in optical coherence tomography strut coverage at 9 months. Key secondary end points included angiographic late lumen loss and composite major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization, and definite or probable stent thrombosis) at 9 months. Resolute Integrity zotarolimus-eluting stent showed significantly better strut coverage than BioMatrix NeoFlex Biolimus A9-eluting stent at 2 to 6 months ( P <0.001) and less variance of percent coverage at 9 months, 99.7% (interquartile range, 99.1-100) versus 99.6% (interquartile range, 96.8-99.9; difference, 0.10; 95% confidence interval, 0.00-1.05; P <0.001). No significant difference was observed in major adverse cardiac events or angiographic end points. Despite having a durable polymer, Resolute Integrity zotarolimus-eluting stent exhibited better strut coverage than BioMatrix NeoFlex Biolimus A9-eluting stent having a biodegradable polymer; both showed similar antiproliferative efficacy. This novel, longitudinal, sequential optical coherence tomography protocol using each patient as own control could achieve conclusive results in small

  3. Does Combination Therapy with Tamsulosin and Tolterodine Improve Ureteral Stent Discomfort Compared with Tamsulosin Alone? A Double-Blind, Randomized, Controlled Trial.

    Science.gov (United States)

    Sivalingam, Sri; Streeper, Necole M; Sehgal, Priyanka D; Sninsky, Brian C; Best, Sara L; Nakada, Stephen Y

    2016-02-01

    Ureteral stent discomfort is a significant postoperative problem for many patients. Despite the use of narcotics and α-blockers patients often experience bothersome lower urinary tract symptoms and pain, which impair daily activities. We compared combination therapy with an α-blocker and an anticholinergic to monotherapy with an α-blocker. A double-blind, randomized, controlled trial was performed from December 2012 to April 2014. A total of 80 patients were randomized, including 44 to the combination group (tamsulosin 0.4 mg and tolterodine early release 4 mg) and 36 to the monotherapy group (tamsulosin 0.4 mg and placebo). Patients with preexisting ureteral stent placement or current anticholinergic therapy were excluded from study. Patients completed USSQ (Urinary Stent Symptom Questionnaire) before stent placement on the day of surgery, the day after stent placement, the morning of stent removal and the day after stent removal. The questionnaire included questions regarding urinary symptoms, general health, body pain, and work and sexual history. A total of 80 patients (40 males and 40 females) were studied. Mean age was 51.5 vs 51.3 years (p = 0.95) and mean body mass index was 33.6 vs 31.9 kg/m(2) (p = 0.44) in monotherapy group 1 vs combination therapy group 2. Between the 2 groups there was no significant difference in urinary symptoms, body pain and activities of daily living from baseline to just before stent removal (p = 0.95, 0.40 and 0.95, respectively). Although there was no difference between the groups, both showed improvement in urinary symptoms from the time of initial stent insertion to just prior to stent removal (difference -0.50 for combination therapy and -0.40 for monotherapy). The mean stent indwelling time of 9.6 and 8.7 days in the combination and monotherapy groups, respectively, did not differ (p = 0.67). On ANOVA it had no significant impact on results (p = 0.64). Combination therapy with tamsulosin and tolterodine does not

  4. Randomized comparison of distal and proximal cerebral protection during carotid artery stenting.

    Science.gov (United States)

    Cano, Manuel N; Kambara, Antônio M; de Cano, Silvia J F; Pezzi Portela, Luiz Antônio; Paes, Ângela Tavares; Costa, J Ribamar; Abizaid, Alexandre Antônio Cunha; Moreira, Samuel Martins; Sousa, Amanda G M R; Sousa, J Eduardo Moraes Rego

    2013-11-01

    This study sought to randomly compare cerebral protection with ANGIOGUARD (Cordis Corporation, Bridgewater, New Jersey) with Mo.Ma (Invatec/Medtronic Vascular Inc, Santa Rosa, California) during carotid artery stenting (CAS), using diffusion-weighted magnetic resonance imaging (DW-MRI) to detect new ischemic cerebral lesions. The number, size, and location of lesions were analyzed. The choice of the type of cerebral protection during CAS is controversial. From July 2008 to July 2011, 60 patients undergoing CAS were randomized to ANGIOGUARD or Mo.Ma, distributed by chance, 30 patients for each group. All patients underwent DW-MRI before and after CAS. An independent neuroradiologist blinded to the cerebral protection used analyzed the images. Univariate and multivariate logistic models were fitted to analyze new ischemic lesions. Alternatively, a propensity score approach was used to reduce the bias due to differences between the groups. For the number of lesions, we used Poisson regression models. New ischemic lesions seen on DW-MRI were present in 63.3% of the ANGIOGUARD group versus 66.7% of the Mo.Ma cohort (p = 0.787). The number of ischemic cerebral lesions per patient, when present, was significantly lower in the Mo.Ma group (a median of 6 lesions per patient vs. a median of 10 in the ANGIOGUARD, p minor stroke during CAS (1.66%). New ischemic lesions seen on DW-MRI were present in both groups in >60%, but the number of lesions per patient was greater in the ANGIOGUARD group. No death or disabling stroke occurred during at least 1 year of follow-up in both cohorts. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. Effectiveness of Positioning Stents in Radiation-Induced Xerostomia in Patients with Tongue Carcinoma: A Randomized Controlled Trial.

    Science.gov (United States)

    Mall, Priyanka; Chand, Pooran; Singh, Balendra Pratap; Rao, Jitendra; Siddarth, Ramashanker; Srivastava, Kirti

    2016-01-01

    The aim of this study was to perform an objective and subjective evaluation of the efficacy of positioning stents in radiation-induced xerostomia in patients with tongue carcinoma. A total of 30 patients with tongue carcinoma and undergoing conventional radiotherapy were randomly assigned to control (n = 15) and study (n = 15) groups, without and with a positioning stent, respectively. Assessment of salivary output reduction was done before and after radiotherapy, at 3- and 6-month intervals, by measurement of unstimulated and stimulated salivary flow rates (objective evaluation). Xerostomia (subjective evaluation) was noted using six items from the Quality of Life Head and Neck Module (QLQ-H&N35) as proposed by the European Organization for Research and Treatment of Cancer. The significance level was set at .05. Mean unstimulated and stimulated salivary flow rates at 3- and 6-month intervals revealed significantly (P xerostomia and its symptoms.

  6. Prospective, randomized study of one, two, or three trabecular bypass stents in open-angle glaucoma subjects on topical hypotensive medication

    Directory of Open Access Journals (Sweden)

    Katz LJ

    2015-12-01

    Full Text Available L Jay Katz,1 Carl Erb,2 Amadeu Carceller Guillamet,3 Antonio M Fea,4 Lilit Voskanyan,5 Jeffrey M Wells,6 Jane Ellen Giamporcaro6 1Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA; 2Eye Clinic Wittenbergplatz, Berlin, Germany; 3Department of Ophthalmology, Hospital d’Hebron, Barcelona, Spain; 4University Eye Clinic of the University of Turin, Turin, Italy; 5SV Malayan Opthalmology Centre, Yerevan, Armenia; 6Glaukos Corporation, Laguna Hills, CA, USA Purpose: To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively.Materials and methods: Subjects with medicated intraocular pressure (IOP 18–30 mmHg and postmedication-washout baseline IOP 22–38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg.Results: A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ≥20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ≤18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ≤15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P<0.001 with implantation of each additional stent, with mean differences in reduction of 1.84 mmHg (95% confidence interval 0.96

  7. Ureteral Stenting after Uncomplicated Ureteroscopy for Distal Ureteral Stones: A Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Y. El Harrech

    2014-01-01

    Full Text Available Objectives. We compared outcome and complications after uncomplicated ureteroscopic treatment of distal ureteral calculi with or without the use of ureteral stents. Materials and Methods. 117 patients, prospectively divided into three groups to receive a double j stent (group 1, 42 patients, ureteral stent (group 2, 37 patients, or no stent (group 3, 38 patients, underwent ureteroscopic treatment of distal ureteral calculi. Stone characteristics, operative time, postoperative pain, lower urinary tract symptoms (LUTS, analgesia need, rehospitalization, stone-free rate, and late postoperative complications were all studied. Results. There were no significant differences in preoperative data. There was no significant difference between the three groups regarding hematuria, fever, flank pain, urinary tract infection, and rehospitalisation. At 48 hours and 1 week, frequency/urgency and dysuria were significantly less in the nonstented group. When comparing group 1 and group 3, patients with double j stents had statistically significantly more bladder pain (P=0.003, frequency/urgency (P=0.002, dysuria (P=0.001, and need of analgesics (P=0.001. All patients who underwent imaging postoperatively were without evidence of obstruction or ureteral stricture. Conclusions. Uncomplicated ureteroscopy for distal ureteral calculi without intraoperative ureteral dilation can safely be performed without placement of a ureteral stent.

  8. FFR-guided multivessel stenting reduces urgent revascularization compared with infarct-related artery only stenting in ST-elevation myocardial infarction: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Gupta, Ankur; Bajaj, Navkaranbir S; Arora, Pankaj; Arora, Garima; Qamar, Arman; Bhatt, Deepak L

    2018-02-01

    Randomized controlled trials (RCTs) have shown fractional flow reserve-guided (FFR) multivessel stenting to be superior to infarct-related artery (IRA) only stenting in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease. This effect was mainly driven by a reduction in overall repeat revascularization. However, the ability to assess the effect of this strategy on urgent revascularization or reinfarction was underpowered in individual trials. We searched Pubmed, EMBASE, Cochrane CENTRAL, and Web of Science for RCTs of FFR-guided multivessel stenting versus IRA-only stenting in STEMI with multivessel disease. The outcomes of interest were death, reinfarction, urgent, and non-urgent repeat revascularization. Risk ratios (RR) were pooled using the DerSimonian and Laird random-effects model. After review of 786 citations, 2 RCTs were included. The pooled results demonstrated a significant reduction in the composite of death, reinfarction, or revascularization in the FFR-guided multivessel stenting group versus IRA-only stenting group (RR [95%, Confidence Interval]: 0.49 [0.33-0.72], p<0.001). This risk reduction was driven mainly by a reduction in repeat revascularization, both urgent (0.41 [0.24-0.71], p=0.002) and non-urgent revascularization (0.31 [0.19-0.50], p<0.001). Pooled RR for reinfarction was lower in the FFR-guided strategy, but was not statistically significant (0.71[0.39-1.31], p=0.28). This systematic review and meta-analysis suggests that a strategy of FFR-guided multivessel stenting in STEMI patients reduces not only overall repeat revascularization but also urgent revascularization. The effect on reinfarction needs to be evaluated in larger trials. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  9. Determining clinical benefits of drug-eluting coronary stents according to the population risk profile: a meta-regression from 31 randomized trials.

    Science.gov (United States)

    Moreno, Raul; Martin-Reyes, Roberto; Jimenez-Valero, Santiago; Sanchez-Recalde, Angel; Galeote, Guillermo; Calvo, Luis; Plaza, Ignacio; Lopez-Sendon, Jose-Luis

    2011-04-01

    The use of drug-eluting stents (DES) in unfavourable patients has been associated with higher rates of clinical complications and stent thrombosis, and because of that concerns about the use of DES in high-risk settings have been raised. This study sought to demonstrate that the clinical benefit of DES increases as the risk profile of the patients increases. A meta-regression analysis from 31 randomized trials that compared DES and bare-metal stents, including overall 12,035 patients, was performed. The relationship between the clinical benefit of using DES (number of patients to treat [NNT] to prevent one episode of target lesion revascularization [TLR]), and the risk profile of the population (rate of TLR in patients allocated to bare-metal stents) in each trial was evaluated. The clinical benefit of DES increased as the risk profile of each study population increased: NNT for TLR=31.1-1.2 (TLR for bare-metal stents); prisk profile of each study population, since the effect of DES in mortality, myocardial infarction, and stent thrombosis, was not adversely affected by the risk profile of each study population (95% confidence interval for β value 0.09 to 0.11, -0.12 to 0.19, and -0.03 to-0.15 for mortality, myocardial infarction, and stent thrombosis, respectively). The clinical benefit of DES increases as the risk profile of the patients increases, without affecting safety. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

  10. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial

    DEFF Research Database (Denmark)

    Galløe, Anders M; Thuesen, Leif; Kelbaek, Henning

    2008-01-01

    Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients.......Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients....

  11. Preoperative biliary drainage by plastic or self-expandable metal stents in patients with periampullary tumors: results of a randomized clinical study

    Science.gov (United States)

    Olsson, Greger; Frozanpor, Farshad; Lundell, Lars; Enochsson, Lars; Ansorge, Christoph; Del Chiaro, Marco; Reuterwall-Hansson, Marcus; Shetye, Alysha; Arnelo, Urban

    2017-01-01

    Background and study aims  Preoperative biliary drainage in patients with periampullary tumors and jaundice has been popularized to improve the quality of life and minimize the risks associated with subsequent radical surgery. The aim of this study was to investigate the possible superiority of self-expandable metal stents (SEMS) over plastic stents, by comparing the amount of bacteria in intraoperatively collected bile and using this variable as a proxy for the efficacy of the respective biliary drainage modalities. Patients and methods  In this randomized clinical trial, 92 patients with obstructive jaundice were enrolled; 45 were allocated to the plastic stent group and 47 to the SEMS group. The primary outcome was the extent and magnitude of biliary bacterial growth at the time of surgical exploration. Secondary outcomes were: macroscopic grading of inflammation of the stented bile ducts, occurrence of adverse events after stenting, stent dysfunction, recognized surgical complexities, and incidence of postoperative complications. Results  The patients were well matched regarding clinical and disease-specific characteristics. At surgery, there were no group differences in the bacterial amount and composition of the bile cultures or the perceived difficulty of surgical dissection. During the preoperative biliary drainage period, more instances of stent dysfunction requiring stent replacement were recorded in the plastic stent group (19 % vs. 0 %; P  = 0.03). Postoperative complications in patients who underwent curative surgery were more common in patients with plastic stents (72 % vs. 52 %), among which clinically significant leakage from the pancreatic anastomoses seemed to predominate (12 % vs. 3.7 %); however, none of these differences in postoperative adverse events reached statistical significance. Conclusion  This randomized clinical study was unable to demonstrate any superiority of SEMS in the efficacy of preoperative bile

  12. A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction

    NARCIS (Netherlands)

    van Berkel, A. M.; Boland, C.; Redekop, W. K.; Bergman, J. J.; Groen, A. K.; Tytgat, G. N.; Huibregtse, K.

    1998-01-01

    Clogging of biliary stents continues to be a major clinical problem. Different polymer materials may have different effects on clogging. In vitro studies have shown a direct relation between the frictional coefficient of a polymer and the amount of encrusted material. Teflon appeared to be the best

  13. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Spiliopoulos, Stavros [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Diamantopoulos, Athanasios [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Karnabatidis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Sabharwal, Tarun [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Siablis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece)

    2013-06-15

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of {>=}50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall

  14. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    International Nuclear Information System (INIS)

    Katsanos, Konstantinos; Spiliopoulos, Stavros; Diamantopoulos, Athanasios; Karnabatidis, Dimitris; Sabharwal, Tarun; Siablis, Dimitris

    2013-01-01

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration’s tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford–Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel–Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18–1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford–Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002–1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28–0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02–1.62, p = 0.04; NNT = 5.9), and better

  15. The short- and long-term outcomes of percutaneous intervention with drug-eluting stent vs bare-metal stent in saphenous vein graft disease: An updated meta-analysis of all randomized clinical trials.

    Science.gov (United States)

    Kheiri, Babikir; Osman, Mohammed; Abdalla, Ahmed; Ahmed, Sahar; Bachuwa, Ghassan; Hassan, Mustafa

    2018-05-11

    The use of drug-eluting stents (DES) vs bare-metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta-analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short- and long-term clinical outcomes of the following: all-cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target-vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short-term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35-0.91, P = 0.02; OR: 0.43, 95% CI: 0.19-0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22-0.95, P = 0.04, respectively). However, there were no different outcomes for all-cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long-term follow-up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all-cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short-term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long-term follow-up. © 2018 Wiley Periodicals, Inc.

  16. Platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention: the ESPRIT trial: a randomized controlled trial.

    Science.gov (United States)

    O'Shea, J C; Hafley, G E; Greenberg, S; Hasselblad, V; Lorenz, T J; Kitt, M M; Strony, J; Tcheng, J E

    2001-05-16

    The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial showed the efficacy of adjunctive, double-bolus eptifibatide therapy in reducing ischemic complications of nonurgent coronary stent implantation at 48 hours and at 30 days. To determine whether the beneficial effects of eptifibatide persist at 6 months after treatment. Follow-up study of a randomized, double-blind, placebo-controlled, crossover-permitted trial conducted from June 1999 through February 2000. Ninety-two tertiary care centers in the United States and Canada. A total of 2064 patients scheduled to undergo nonurgent percutaneous coronary intervention with stent implantation. Patients were randomly assigned to receive placebo or eptifibatide (two 180-microg/kg boluses 10 minutes apart and continuous infusion of 2.0 microg/kg per minute), started immediately before stent implantation and continued for 18 to 24 hours. Complete follow-up data were available for 988 (95.0%) of 1040 patients given eptifibatide and 977 (95.4%) of 1024 patients given placebo. Composite rates of death or myocardial infarction (MI); death, MI, or target vessel revascularization; and their individual components 6 months after enrollment, compared between the 2 groups. By 6 months, the composite end point of death or MI had occurred in 7.5% of eptifibatide-treated patients and in 11.5% of placebo-treated patients (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.47-0.84; P =.002). The composite of death, MI, or target vessel revascularization was 14.2% in eptifibatide-treated patients vs 18.3% in placebo-treated patients (HR, 0.75; 95% CI, 0.60-0.93; P =.008). Most of this benefit accrued early (<48 hours after initiation of therapy) and was maintained through 6 months. Six-month mortality in the eptifibatide group was 0.8% vs 1.4% in the placebo group (HR, 0.56; 95% CI, 0.24-1.34; P =.19) and target vessel revascularization occurred in 8.6% of the eptifibatide group vs 9.4% of

  17. Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis).

    Science.gov (United States)

    Kandzari, David E; Smits, Pieter C; Love, Michael P; Ben-Yehuda, Ori; Banai, Shmuel; Robinson, Simon D; Jonas, Michael; Kornowski, Ran; Bagur, Rodrigo; Iniguez, Andres; Danenberg, Haim; Feldman, Robert; Jauhar, Rajiv; Chandna, Harish; Parikh, Manish; Perlman, Gidon Y; Balcells, Mercedes; Markham, Peter; Ozan, Melek Ozgu; Genereux, Philippe; Edelman, Elazer R; Leon, Martin B; Stone, Gregg W

    2017-10-03

    The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, P noninferiority =0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P =0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm ( P noninferiority =0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively ( P noninferiority =0.01). In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. URL: http

  18. A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos).

    Science.gov (United States)

    Canena, Jorge; Liberato, Manuel; Meireles, Liliane; Marques, Inês; Romão, Carlos; Coutinho, António Pereira; Neves, Beatriz Costa; Veiga, Pedro Mota

    2015-07-01

    Endoscopic management of postcholecystectomy biliary leaks is widely accepted as the treatment of choice. However, refractory biliary leaks after a combination of biliary sphincterotomy and the placement of a large-bore (10F) plastic stent can occur, and the optimal rescue endotherapy for this situation is unclear. To compare the clinical effectiveness of the use of a fully covered self-expandable metal stent (FCSEMS) with the placement of multiple plastic stents (MPS) for the treatment of postcholecystectomy refractory biliary leaks. Prospective study. Two tertiary-care referral academic centers and one general district hospital. Forty consecutive patients with refractory biliary leaks who underwent endoscopic management. Temporary placement of MPS (n = 20) or FCSEMSs (n = 20). Clinical outcomes of endotherapy as well as the technical success, adverse events, need for reinterventions, and prognostic factors for clinical success. Endotherapy was possible in all patients. After endotherapy, closure of the leak was accomplished in 13 patients (65%) who received MPS and in 20 patients (100%) who received FCSEMSs (P = .004). The Kaplan-Meier (log-rank) leak-free survival analysis showed a statistically significant difference between the 2 patient populations (χ(2) [1] = 8.30; P stents (P = .024), a plastic stent diameter <20F (P = .006), and a high-grade biliary leak (P = .015) were shown to be significant predictors of treatment failure with MPS. The 7 patients in whom placement of MPS failed were retreated with FCSEMSs, resulting in closure of the leaks in all cases. Non-randomized design. In our series, the results of the temporary placement of FCSEMSs for postcholecystectomy refractory biliary leaks were superior to those from the use of MPS. A randomized study is needed to confirm our results before further recommendations. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  19. Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial.

    Science.gov (United States)

    Yang, Min Jae; Kim, Jin Hong; Yoo, Byung Moo; Hwang, Jae Chul; Yoo, Jun Hwan; Lee, Ki Seong; Kang, Joon Koo; Kim, Soon Sun; Lim, Sun Gyo; Shin, Sung Jae; Cheong, Jae Youn; Lee, Kee Myung; Lee, Kwang Jae; Cho, Sung Won

    2015-01-01

    Covered self-expandable metal stents (SEMSs) are increasingly used as alternatives to uncovered SEMSs for the palliation of inoperable malignant distal biliary obstruction to counteract tumor ingrowth. We aimed to compare the outcomes of partially covered and uncovered SEMSs with identical mesh structures and anti-migration properties, such as low axial force and flared ends. One hundred and three patients who were diagnosed with inoperable malignant distal biliary obstruction between January 2006 and August 2013 were randomly assigned to either the partially covered (n = 51) or uncovered (n = 52) SEMS group. There were no significant differences in the cumulative stent patency, overall patient survival, stent dysfunction-free survival and overall adverse events, including pancreatitis and cholecystitis, between the two groups. Compared to the uncovered group, stent migration (5.9% vs. 0%, p = 0.118) and tumor overgrowth (7.8% vs. 1.9%, p = 0.205) were non-significantly more frequent in the partially covered group, whereas tumor ingrowth showed a significantly higher incidence in the uncovered group (5.9% vs. 19.2%, p = 0.041). Stent migration in the partially covered group occurred only in patients with short stenosis of the utmost distal bile duct (two in ampullary cancer, one in bile duct cancer), and did not occur in any patients with pancreatic cancer. For the palliation of malignant distal biliary obstruction, endoscopic placement of partially covered SEMSs with anti-migration designs and identical mesh structures to uncovered SEMSs failed to prolong cumulative stent patency or reduce stent migration.

  20. Rationale and Design of a Randomized Clinical Comparison of Everolimus-Eluting (Xience V/Promus) and Sirolimus-Eluting (Cypher Select+) Coronary Stents in Unselected Patients with Coronary Heart Disease

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Tilsted, Hans Henrik

    2010-01-01

    with Clinical Outcome (SORT OUT) IV trial was designed as a prospective, multi-center, open-label, all-comer, two-arm, randomized, non-inferiority study comparing the everolimus-eluting stent with the sirolimus-eluting stent in the treatment of atherosclerotic coronary artery lesions. Based on a non...

  1. Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial.

    Science.gov (United States)

    Chen, Shao-Liang; Zhang, Jue-Jie; Han, Yaling; Kan, Jing; Chen, Lianglong; Qiu, Chunguang; Jiang, Tiemin; Tao, Ling; Zeng, Hesong; Li, Li; Xia, Yong; Gao, Chuanyu; Santoso, Teguh; Paiboon, Chootopol; Wang, Yan; Kwan, Tak W; Ye, Fei; Tian, Nailiang; Liu, Zhizhong; Lin, Song; Lu, Chengzhi; Wen, Shangyu; Hong, Lang; Zhang, Qi; Sheiban, Imad; Xu, Yawei; Wang, Lefeng; Rab, Tanveer S; Li, Zhanquan; Cheng, Guanchang; Cui, Lianqun; Leon, Martin B; Stone, Gregg W

    2017-11-28

    Provisional stenting (PS) is the most common technique used to treat distal left main (LM) bifurcation lesions in patients with unprotected LM coronary artery disease undergoing percutaneous coronary intervention. The double kissing (DK) crush planned 2-stent technique has been shown to improve clinical outcomes in non-LM bifurcations compared with PS, and in LM bifurcations compared with culotte stenting, but has never been compared with PS in LM bifurcation lesions. The authors sought to determine whether a planned DK crush 2-stent technique is superior to PS for patients with true distal LM bifurcation lesions. The authors randomized 482 patients from 26 centers in 5 countries with true distal LM bifurcation lesions (Medina 1,1,1 or 0,1,1) to PS (n = 242) or DK crush stenting (n = 240). The primary endpoint was the 1-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Routine 13-month angiographic follow-up was scheduled after ascertainment of the primary endpoint. TLF within 1 year occurred in 26 patients (10.7%) assigned to PS, and in 12 patients (5.0%) assigned to DK crush (hazard ratio: 0.42; 95% confidence interval: 0.21 to 0.85; p = 0.02). Compared with PS, DK crush also resulted in lower rates of target vessel myocardial infarction I (2.9% vs. 0.4%; p = 0.03) and definite or probable stent thrombosis (3.3% vs. 0.4%; p = 0.02). Clinically driven target lesion revascularization (7.9% vs. 3.8%; p = 0.06) and angiographic restenosis within the LM complex (14.6% vs. 7.1%; p = 0.10) also tended to be less frequent with DK crush compared with PS. There was no significant difference in cardiac death between the groups. In the present multicenter randomized trial, percutaneous coronary intervention of true distal LM bifurcation lesions using a planned DK crush 2-stent strategy resulted in a lower rate of TLF at 1 year than a PS

  2. Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Adamson, Douglas; Blazeby, Jane; Nelson, Annmarie; Hurt, Chris; Nixon, Lisette; Fitzgibbon, Jim; Crosby, Tom; Staffurth, John; Evans, Mim; Kelly, Noreen Hopewell; Cohen, David; Griffiths, Gareth; Byrne, Anthony

    2014-10-22

    The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion. The study is a randomized multicenter phase III trial, with an internal pilot phase, comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer. Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia. Radiotherapy will be administered as 20 Gray (Gy) in five fractions over one week or 30 Gy in 10 fractions over two weeks, within four weeks of stent insertion. The internal pilot will assess rates and methods of recruitment; pre-agreed criteria will determine progression to the main trial. In total, 496 patients will be randomized in a 1:1 ratio with follow up until death. The primary outcome is time to progression of patient-reported dysphagia. Secondary outcomes include survival, toxicity, health resource utilization, and quality of life. An embedded qualitative study will explore the feasibility of patient recruitment by examining patients' motivations for involvement and their experiences of consent and recruitment, including reasons for not consenting. It will also explore patients' experiences of each trial arm. The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on

  3. Stent-protected angioplasty versus carotid endarterectomy in patients with carotid artery stenosis: meta-analysis of randomized trial data

    International Nuclear Information System (INIS)

    Wiesmann, Martin; Schoepf, Veronika; Brueckmann, Hartmut; Jansen, Olav

    2008-01-01

    Stent-protected angioplasty of carotid artery stenosis may be an alternative to surgical endarterectomy. Results published so far are indecisive, with evidence both in favour of and against this procedure. After the recent publication of two large European multicentre trials (SPACE and EVA-3S) almost 3,000 patients have been included in randomized studies. For this report, we therefore conducted a systematic review of randomized studies that compared endovascular treatment with surgery for carotid stenosis. We evaluated seven trials including 2,973 patients. In our meta-analysis endovascular treatment seemed to carry a slightly higher risk for stroke or death within 30 days after the procedure as compared with surgery (8.2% vs. 6.2%; p = 0.04; OR 1.35), whereas the rates of disabling stroke or death within 30 days did not differ significantly (p = 0.47; n.s.). On the other hand, surgery carried a significantly higher risk for cranial nerve palsy (4.7% vs. 0.2%; p < 0.0001; OR 0.17) and myocardial infarction (2.3% vs. 0.9%; p = 0.03; OR 0.37). Long-term effects of both methods still need to be evaluated. Two other large multicentre trials (ICSS and CREST) are ongoing. Results of these studies will increase the database to about 7,000 randomized patients. Future meta-analyses should then allow definitive treatment recommendations. (orig.)

  4. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy

    International Nuclear Information System (INIS)

    Jiménez, Victor A.; Iñiguez, Andrés; Baz, José A.; Valdés, Mariano; Ortiz, Alberto; Vuilliomenet, André; Mainar, Vicente; Dudek, Dariusz; Banai, Shmuel; Tüller, David; Bonnet, Jean-Louis; De Miguel, Antonio; Bastos, Guillermo; Wijns, William; Saito, Shigeru

    2016-01-01

    Background: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. Methods: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9 month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24 months. Results: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24 months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P = 0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P = 0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. Conclusions: BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up. - Highlights: • This study reported the 24-month clinical outcomes of new-generation BP-SES compared with PP-EES in ACS subgroup from CENTURY II study. • This is a pre-specified subgroup analysis of a large randomized, prospective, multicenter clinical trial. • The BP-SES showed good and comparable clinical performance as PP-EES at 24 months. • This substudy has a relatively small sample size and

  5. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy

    Energy Technology Data Exchange (ETDEWEB)

    Jiménez, Victor A., E-mail: victor.alfonso.jimenez.diaz@sergas.es [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Iñiguez, Andrés; Baz, José A. [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Valdés, Mariano [Hospital Universitario V. Arrixaca, Murcia (Spain); Ortiz, Alberto [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Vuilliomenet, André [Kantonsspital Aarau, Aarau (Switzerland); Mainar, Vicente [Department of Cardiology, University General Hospital of Alicante, Alicante (Spain); Dudek, Dariusz [Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow (Poland); Banai, Shmuel [Tel Aviv Sourasky Medical Centre, Tel Aviv (Israel); Tüller, David [Department of Cardiology, Stadtspital Triemli, Zürich (Switzerland); Bonnet, Jean-Louis [Department of Cardiology, Hospital La Timone, Marseille (France); De Miguel, Antonio; Bastos, Guillermo [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Wijns, William [Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium); Saito, Shigeru [Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura (Japan)

    2016-09-15

    Background: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. Methods: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9 month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24 months. Results: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24 months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P = 0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P = 0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. Conclusions: BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up. - Highlights: • This study reported the 24-month clinical outcomes of new-generation BP-SES compared with PP-EES in ACS subgroup from CENTURY II study. • This is a pre-specified subgroup analysis of a large randomized, prospective, multicenter clinical trial. • The BP-SES showed good and comparable clinical performance as PP-EES at 24 months. • This substudy has a relatively small sample size and

  6. Rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial.

    Science.gov (United States)

    de Waha, Suzanne; Allali, Abdelhakim; Büttner, Heinz-Joachim; Toelg, Ralph; Geist, Volker; Neumann, Franz-Josef; Khattab, Ahmed A; Richardt, Gert; Abdel-Wahab, Mohamed

    2016-03-01

    In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported. ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups. Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA. © 2015 Wiley Periodicals, Inc.

  7. Risk reduction of brain infarction during carotid endarterectomy or stenting using sonolysis - Prospective randomized study pilot data

    Science.gov (United States)

    Kuliha, Martin; Školoudík, David; Martin Roubec, Martin; Herzig, Roman; Procházka, Václav; Jonszta, Tomáš; Krajča, Jan; Czerný, Dan; Hrbáč, Tomáš; Otáhal, David; Langová, Kateřina

    2012-11-01

    Sonolysis is a new therapeutic option for the acceleration of arterial recanalization. The aim of this study was to confirm risk reduction of brain infarction during endarterectomy (CEA) and stenting (CAS) of the internal carotid artery (ICA) using sonolysis with continuous transcranial Doppler (TCD) monitoring by diagnostic 2 MHz probe, additional interest was to assess impact of new brain ischemic lesions on cognitive functions. Methods: All consecutive patients 1/ with ICA stenosis >70%, 2/ indicated to CEA or CAS, 3/ with signed informed consent, were enrolled to the prospective study during 17 months. Patients were randomized into 2 groups: Group 1 with sonolysis during intervention and Group 2 without sonolysis. Neurological examination, assessment of cognitive functions and brain magnetic resonance imaging (MRI) were performed before and 24 hours after intervention in all patients. Occurrence of new brain infarctions (including infarctions >0.5 cm3), and the results of Mini-Mental State Examination, Clock Drawing and Verbal Fluency tests were statistically evaluated using T-test. Results: 97 patients were included into the study. Out of the 47 patients randomized to sonolysis group (Group 1) 25 underwent CEA (Group 1a) and 22 CAS (Group 1b). Out of the 50 patients randomized to control group (Group 2), 22 underwent CEA (Group 2a) and 28 CAS (Group 2b). New ischemic brain infarctions on follow up MRI were found in 14 (29.8%) patients in Group 1-4 (16.0%) in Group 1a and 10 (45.5%) in Group 1b. In Group 2, new ischemic brain infarctions were found in 18 (36.0%) patients-6 (27.3%) in Group 2a and 12 (42.9%) in Group 2b (p>0.05 in all cases). New ischemic brain infarctions >0.5 cm3 were found in 4 (8.5 %) patients in Group 1 and in 11 (22.0 %) patients in Group 2 (p= 0.017). No significant differences were found in cognitive tests results between subgroups (p>0.05 in all tests). Conclusion: Sonolysis seems to be effective in the prevention of large ischemic

  8. Expandable stents.

    Science.gov (United States)

    Nesbitt, J C; Carrasco, H

    1996-05-01

    Expandable metallic stents are effective in selected patients with malignant or benign airway stenoses. When used for malignant lesions, the primary purpose of the stent is to improve the quality of life; stents are usually chosen for palliation of symptoms in recognition of the low likelihood of success for other therapy. For patients with benign stenoses, the stents provide a permanent source of structural support to alleviate the narrowed segment. The advantages of the expandable metallic stents are as follows: (1) they can be inserted through an endotracheal tube or under local anesthesia with relative simplicity under fluoroscopic guidance; (2) they do not impair the drainage of sputum because ciliary movement is not interrupted; (3) over a period of a few weeks, the meshwork is gradually covered with mucosa as the stent becomes incorporated into the airway wall; (4) ventilation usually is not impaired if the metallic mesh stent covers another nonstenosed bronchus, because the interstices of the stent are nonobstructive; and (5) they are dynamic and continue to expand over time, particularly if concurrent treatment achieves an effect on the lesion that caused stenosis. Disadvantages of the expandable stent include (1) they often are only temporarily effective for tracheobronchial stenosis due to intraluminal tumor or granulation tissue, both of which can grow between the wires; (2) they are considered permanent stents because removal is difficult; and (3) they can be poorly positioned during placement or can become displaced by progressive migration after placement, and they cannot be repositioned. A relative contraindication to insertion is an inflammatory process or infection that can predispose to granulation formation, particularly at the points of maximal contact pressure of the stent to the airway mucosa. In the presence of inflammation, it may be better to use a silicone prosthesis until the inflammatory process subsides and fibrosis occurs. Granulation

  9. Randomized Controlled Trial to Compare the Safety and Efficacy of Tamsulosin, Solifenacin, and Combination of Both in Treatment of Double-J Stent-Related Lower Urinary Symptoms

    Directory of Open Access Journals (Sweden)

    Essam Shalaby

    2013-01-01

    Full Text Available Purpose. We evaluated the effectiveness and safety of tamsulosin, solifenacin, and combination of both in reducing double-J stent-related lower urinary symptoms. Materials and Methods. A total of 338 patients with double-J ureteral stenting were randomly divided, postoperatively, into 4 groups. In group I (, no treatment was given (control group, group II ( received tamsulosin 0.4 mg daily, group III ( received solifenacin 10 mg daily, and group IV ( received a combination of both medications. Before insertion and 2 weeks after, all patients completed the International Prostate Symptom Score (IPSS, quality of life component of the IPSS (IPSS/Qol, Overactive Bladder Questionnaire (OAB-q, and Visual Analogue Pain Scale (VAPS questionnaire. Results. The demographics and preoperative questionnaires scores of all groups were comparable. There were statistically significant differences in all scores in favour of groups II, III, and IV as compared to control group ( value < 0.005. Group IV showed statistically significant differences in total IPSS, QoL score, and OAB-q score as compared to groups II and III ( value < 0.001. Conclusions. Combined therapy of tamsulosin and solifenacin significantly alleviated lower urinary symptoms associated with double-J stents as compared to either medication alone.

  10. A Randomized Controlled Trial to Compare the Safety and Efficacy of Tadalafil and Tamsulosin in Relieving Double J Stent Related Symptoms

    Directory of Open Access Journals (Sweden)

    Satinder Pal Aggarwal

    2015-01-01

    Full Text Available Objectives. To evaluate the safety and efficacy of Tadalafil and Tamsulosin in treating Double J stent related symptoms. Methods. In a prospective study, 161 patients with DJ related symptoms were randomized into 3 groups: Group A patients (54, Group B patients (53, and Group C patients (54. They were given Tadalafil, Tamsulosin, and placebo, respectively, at 1st week till removal of DJ stent at 3rd week. All patients completed Ureteral Stent Symptom Questionnaire (USSQ at 1st week and at 3rd week. The statistical significant difference among groups was determined by the t-test, Kruskal-Wallis test and multivariate analysis were used to assess association of the variables within the three groups, and the level of significance was set at P<0.05. Results. Tadalafil and Tamsulosin were comparable in relieving urinary symptoms, general health, and work performance (OR = 0.65, 1.8, and 0.92. But Tadalafil was more effective in relieving body pain, sexual problems, and additional problems than Tamsulosin (OR = 5.95, 19.25, and 2.69 and was statistically significant as P<0.05. Conclusion. Tadalafil was as effective as Tamsulosin in relieving urinary symptom but more effective in relieving sexual symptoms and body pain.

  11. The Effect of Stent Cell Geometry on Carotid Stenting Outcomes

    Energy Technology Data Exchange (ETDEWEB)

    Alparslan, Burcu, E-mail: burcu.alparslan@gmail.com [Yozgat State Hospital, Radiology Clinic (Turkey); Nas, Omer Fatih, E-mail: omerfatihnas@gmail.com [Uludag University Faculty of Medicine, Department of Radiology (Turkey); Eritmen, Ulku Turpcu, E-mail: drulkutur@hotmail.com.tr [Special Eregli Anatolia Hospital, Radiology Clinic (Turkey); Duran, Selcen, E-mail: selcenduran16@hotmail.com [Yerkoy State Hospital, Neurology Clinic (Turkey); Ozkaya, Guven, E-mail: ozkaya@uludag.edu.tr [Uludag University Faculty of Medicine, Department of Biostatistics (Turkey); Hakyemez, Bahattin, E-mail: bhakyemez@uludag.edu.tr [Uludag University Faculty of Medicine, Department of Radiology (Turkey)

    2016-04-15

    PurposeThe aim of this study was to investigate the effect of stent cell geometry on midterm results of carotid artery stenting (CAS).Materials and MethodOne hundred fifty-five patients underwent CAS between February 2010 and December 2012. Ninety-one open- and 84 closed-cell stents were used in this non-randomized, retrospective study. Periprocedural complications were defined as the ones happened during the procedure or within 30 days afterwards. Starting from the 6th month after the procedure, in-stent restenosis was detected with multidetector computed tomography angiography and classified into four groups from focal restenosis to occlusion.ResultsEleven complications were encountered in the periprocedural period (four on the open- and seven on the closed-cell group). Total complication rate was 6.3 % (11/175). No significant difference was detected in terms of periprocedural complications between two groups (p = 0.643). There was statistically significant difference between stent design groups in regard to radiological findings (p = 0.002). Sixteen of open-cell stents and three of closed-cell stents had focal restenosis. One closed-cell stent had diffuse proliferative restenosis and one open-cell stent had total occlusion.ConclusionIn-stent restenosis was more common in open-cell stent group, which have larger free cell area than closed-cell stents. Although our radiologic findings promote us to use closed-cell design if ‘possible’, no difference was detected in terms of clinical outcomes.

  12. Design of the Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST): a randomized clinical trial.

    Science.gov (United States)

    Malas, Mahmoud B; Qazi, Umair; Glebova, Natalia; Arhuidese, Isibor; Reifsnyder, Thomas; Black, James; Perler, Bruce A; Freischlag, Julie A

    2014-12-01

    To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments. To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications. ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus. Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire. The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled

  13. Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

    Directory of Open Access Journals (Sweden)

    Fea AM

    2014-05-01

    Full Text Available Antonio M Fea,1 Jose I Belda,2 Marek Rękas,3 Anselm Jünemann,4 Lydia Chang,5 Luis Pablo,6 Lilit Voskanyan,7 L Jay Katz81Università degli Studi di Torino, Clinica Oculistica, Torino, Italy; 2Hospital Torrevieja Salud, UTE, Servicio de Oftalmologia, Alicante, Spain; 3Military Institute of Medicine, Department of Ophthalmology, Warsaw, Poland; 4Universitätsaugenklinik, Erlangen, Germany; 5Hinchingbrooke Hospital NHS Trust and Moorfields Bedford Hospital NHS Trust, United Kingdom; 6Hospital Universitario Miguel Servet, Servicio Oftalmologico, Zaragoza, Spain; 7SV Malayan Ophthalmological Center, Yerevan, Armenia; 8Wills Eye Institute, Jefferson Medical College, Philadelphia, PA, USAPurpose: The purpose of this study was to compare outcomes of subjects with open-angle glaucoma (OAG not controlled on one medication who underwent either implantation of two iStent inject® trabecular micro-bypass devices or received medical therapy consisting of a fixed combination of latanoprost/timolol.Patients and methods: Of 192 subjects who qualified for the study and were enrolled, 94 were randomized to surgery with implantation of two iStent inject® devices in the treated eye and 98 to receive medical therapy.Results: At the month 12 visit, 94.7% of eyes (89/94 in the stent group reported an unmedicated intraocular pressure (IOP reduction of ≥20% versus baseline unmedicated IOP, and 91.8% of eyes (88/98 in the medical therapy group reported an IOP reduction ≥20% versus baseline unmedicated IOP. A 17.5% between-group treatment difference in favor of the iStent inject group was statistically significant (P=0.02 at the ≥50% level of IOP reduction. An IOP ≤18 mmHg was reported in 92.6% of eyes (87/94 in the iStent inject group and 89.8% of eyes (88/98 in the medical therapy group. Mean (standard deviation IOP decreases from screening of 8.1 (2.6 mmHg and 7.3 (2.2 mmHg were reported in the iStent inject and medical therapy groups, respectively. A high

  14. TCT-584 Nine Month Imaging and Twelve Month Clinical Results from the DESSOLVE II Randomized Trial of the MiStent® SES with Absorbable Polymer

    OpenAIRE

    Wijns, William; Vrolix, Mathias; Verheye, Stefan; Schoors, Danny; Slagboom, Ton; Gosselink, Marcel; Benit, Edouard; Desmet, Walter; Chowdhary, Saquib; Lansky, Alexandra; Bezerra, Hiram; Fitzgerald, Peter; Kandzari, David; Ormiston, John

    2012-01-01

    Background : The MiStent SES (Micell Technologies, Durham, NC) is an investigational drug-eluting stent (DES) developed to adress unfavorable late-term outcomes such as stent thrombosis. These events are hypothesized to be associated in part with durable polymers of current DES. The MiStent SES uses a unique combination of components, a crystalline formulation of sirolimus and a fully absorbable polymer on a thinstrut, cobalt chromium stent platform. The polymer coating is eliminated from the...

  15. Agreement of duplex ultrasonography vs. computed tomography angiography for evaluation of native and in-stent SFA re-stenosis—Findings from a randomized controlled trial

    International Nuclear Information System (INIS)

    Langenberger, Herbert; Schillinger, Martin; Plank, Christina; Sabeti, Schila; Dick, Petra; Cejna, Manfred; Lammer, Johannes; Minar, Erich; Loewe, Christian

    2012-01-01

    Background: Multidetector CT angiography (CTA) is a non-invasive imaging technique for evaluation of peripheral vascular disease. CTA might be particularly useful for assessment of intermediate- and long-term morphological outcome after endovascular treatment. Validation of CTA vs. the current imaging standard, colour Doppler ultrasonography (CDUS), for quantification of native and in-stent re-stenosis in the superficial femoral artery (SFA) is required. Methods: Seventy randomized patients who underwent stent implantation (n = 47) or balloon angioplasty (n = 23) underwent 6-month follow-up with CDUS and CTA. CTA was compared with CDUS in both sub-groups of patients in terms of binary re-stenosis (>50% lumen narrowing) and re-occlusion. Agreement between CTA and CDUS was assessed using Kappa (κ) statistics with 95% confidence intervals, and correlation coefficients. Results: Binary re-stenosis was detected in 16/70 (22.9%) patients by CTA and 17/70 (24.3%) patients by CDUS (κ = 0.88, 95% CI: 0.80–0.96). Re-stenosis rates after balloon angioplasty were 39.1% (9/23) on CTA and CDUS (κ = 0.82, 95% CI: 0.66–0.98), and after stent implantation 14.9% (7/47) on CTA and 17.0% (8/47) on CDUS (κ = 0.92, 95% CI: 0.84–1.00). Re-occlusions were detected in 3/70 (4.3%) patients by both CTA and CDUS (κ = 0.65; 95% CI 0.54–0.76). Significant correlations (r = 0.85, p < 0.001) were noted between degree of re-stenosis on CTA and peak velocity ratio on CDUS. The correlation coefficient was higher in patients after balloon angioplasty (r = 0.94, p < 0.001) than in patients after stent implantation (r = 0.71, p < 0.001). Conclusion: CTA and CDUS show excellent agreement for evaluation of native and in-stent re-stenosis after endovascular treatment of SFA obstructions. CTA is an appropriate non-invasive imaging modality for follow-up after endovascular therapy

  16. Comparing Stent Thrombosis associated with Zotarolimus Eluting Stents versus Everolimus Eluting Stents at 1 year follow up: a systematic review and meta-analysis of 6 randomized controlled trials.

    Science.gov (United States)

    Bundhun, Pravesh Kumar; Yanamala, Chandra Mouli; Huang, Wei-Qiang

    2017-03-16

    Two thousand fifteen has been a winning year for Drug Eluting Stents (DES). Increase in the number of patients with cardiovascular diseases treated by Percutaneous Coronary Intervention (PCI) has resulted to a high demand for second generation DES. This current analysis aimed to compare the different types of Stent Thrombosis (ST) associated with Zotarolimus Eluting Stents (ZES) versus Everolimus Eluting Stents (EES) at 1 year follow up. Electronic databases were searched for studies comparing ZES with EES. Different types of ST reported at 1 year follow up were considered as the primary endpoints in this analysis. Odds Ratios (OR) with 95% Confidence Intervals (CIs) were used as the statistical parameters and the pooled analyses were carried out by the RevMan 5 · 3 software. A total number of 10,512 patients were included in this analysis. No significant difference in any definite ST, acute definite ST, subacute definite ST, and late definite ST were observed between ZES and EES, at 1 year follow up with OR: 1.70, 95% CI: 0.92 - 3.16; P = 0.09, OR: 3.44, 95% CI: 0.82 - 14.43; P = 0.09, OR: 1.13, 95% CI: 0.43 - 2.95; P = 0.80 and OR: 2.39, 95% CI: 0.83 - 6.85; P = 0.11 respectively. Moreover, any definite or probable ST and definite/probable/possible ST were also not significantly different with OR: 1.39, 95% CI: 0.89 - 2.17; P = 0.15 and OR: 1.19, 95% CI: 0.84 - 1.70; P = 0.33 respectively. In addition, any probable ST, acute probable ST, late probable ST and possible ST were also not significantly different at 1 year follow up with OR: 1.11, 95% CI: 0.60 - 2.05; P = 0.75, OR: 0.53, 95% CI: 0.12 - 2.40; P = 0.41, OR: 1.67, 95% CI: 0.35 - 7.86; P = 0.52 and OR: 1.08, 95% CI: 0.64 - 1.82; P = 0.78 respectively. At 1 year follow up, ZES were not associated with significantly lower or higher definite and probable ST compared to EES. In addition, no significant difference was observed in acute, subacute and late

  17. Airway stents

    Science.gov (United States)

    Keyes, Colleen

    2018-01-01

    Stents and tubes to maintain the patency of the airways are commonly used for malignant obstruction and are occasionally employed in benign disease. Malignant airway obstruction usually results from direct involvement of bronchogenic carcinoma, or by extension of carcinomas occurring in the esophagus or the thyroid. External compression from lymph nodes or metastatic disease from other organs can also cause central airway obstruction. Most malignant airway lesions are surgically inoperable due to advanced disease stage and require multimodality palliation, including stent placement. As with any other medical device, stents have significantly evolved over the last 50 years and deserve an in-depth understanding of their true capabilities and complications. Not every silicone stent is created equal and the same holds for metallic stents. Herein, we present an overview of the topic as well as some of the more practical and controversial issues surrounding airway stents. We also try to dispel the myths surrounding stent removal and their supposed use only in central airways. At the end, we come to the long-held conclusion that stents should not be used as first line treatment of choice, but after ruling out the possibility of curative surgical resection or repair. PMID:29707506

  18. Renal PTA stenting

    International Nuclear Information System (INIS)

    Tsetis, D.

    2012-01-01

    Full text: Renal artery stenosis (RAS) is a common condition that may lead to hypertension, progressive renal dysfunction and cardiovascular morbidity. Catheter-based therapy for symptomatic, haemodynamically significant, RAS has become the preferred method of revascularization. Balloon angioplasty has been the traditional treatment of choice for fibromuscular dysplasia, however stents are increasingly used for the treatment of atheromatous lesions; in many cases-such as in ostial lesions-, direct stenting is strongly indicated. Despite the increased use of endovascular therapy for renal artery stenosis, there is still controversy regarding the optimal management and the net benefit of this treatment. Several randomized trials of balloon angioplasty or stenting for renal artery stenosis compared with medical therapy alone have been conducted, however these could not show definite advantage of endovascular therapy. Problems encountered with those trials include enrollment of small number of patients, frequent crossover from medical to interventional therapy compromising the intention-to-treat results, or selection of patients that are not expected to show clear benefit. The Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) is the most important of these trials; however, it,s study design was faulty and therefore did not provide conclusive evidence to answer the question of whether angioplasty and stenting or medical therapy is the best treatment for haemodynamically significant RAS. All expectations are now focused on the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial which was designed to answer the same question, and its methodologies took into consideration the weaknesses of the ASTRAL trial. Regarding stent device itself, it seems that the optimal design is probably a stainless steel, laser cut, open-cells stent mounted on a rapid exchange delivery balloon catheter compatible with 0.014-in and 0.018-in guidewire. As a future

  19. Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease).

    Science.gov (United States)

    Lammer, Johannes; Zeller, Thomas; Hausegger, Klaus A; Schaefer, Philipp J; Gschwendtner, Manfred; Mueller-Huelsbeck, Stefan; Rand, Thomas; Funovics, Martin; Wolf, Florian; Rastan, Aljoscha; Gschwandtner, Michael; Puchner, Stefan; Ristl, Robin; Schoder, Maria

    2013-10-08

    The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested. Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory. In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p stents compared with BMS in lesions ≥20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare

  20. Direct coronary stenting in reducing radiation and radiocontrast consumption

    International Nuclear Information System (INIS)

    Caluk, Jasmin; Osmanovic, Enes; Barakovic, Fahir; Kusljugic, Zumreta; Terzic, Ibrahim; Caluk, Selma; Sofic, Amela

    2010-01-01

    Coronary stenting is the primary means of coronary revascularization. There are two basic techniques of stent implantation: stenting with balloon predilatation of stenosis and stenting without predilatation (direct stenting). Limiting the time that a fluoroscope is activated and by appropriately managing the intensity of the applied radiation, the operator limits radiation in the environment, and this saves the exposure to the patient and all personnel in the room. Nephrotoxicity is one of the most important properties of radiocontrast. The smaller amount of radiocontrast used also provides multiple positive effects, primarily regarding the periprocedural risk for the patients with the reduced renal function. The goal of the study was to compare fluoroscopy time, the amount of radiocontrast, and expenses of material used in direct stenting and in stenting with predilatation. In a prospective study, 70 patients with coronary disease were randomized to direct stenting, or stenting with predilatation. Fluoroscopy time and radiocontrast use were significantly reduced in the directly stented patients in comparison to the patients stented with balloon-predilatation. The study showed a significant reduction of expenses when using a direct stenting method in comparison to stenting with predilatation. If the operator predicts that the procedure can be performed using direct stenting, he is encouraged to do so. Direct stenting is recommended for all percutaneous coronary interventions when appropriate conditions have been met. If direct stenting has been unsuccessful, the procedure can be converted to predilatation

  1. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial

    NARCIS (Netherlands)

    Serruys, Patrick W.; Ong, Andrew T. L.; Piek, Jan J.; Neumann, Franz-Josef; van der Giessen, Willem J.; Wiemer, Marcus; Zeiher, Andreas; Grube, Eberhard; Haase, Jürgen; Thuesen, Leif; Hamm, Christian; Otto-Terlouw, Patricia C.

    2005-01-01

    Background: Everolimus is a sirolimus analogue with similar efficacy in animal models, and has been previously successfully tested in humans using an erodable polymer.Methods: This first-in-man single blind multi-centre randomized controlled trial assessed the safety and efficacy of everolimus

  2. Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients

    NARCIS (Netherlands)

    Navarese, E.P.; Kowalewski, M.; Cortese, B.; Kandzari, D.; Dias, S.; Wojakowski, W.; Buffon, A.; Lansky, A.; Angelini, P.; Torguson, R.; Kubica, J.; Kelm, M.; Boer, M.J. de; Waksman, R.; Suryapranata, H.

    2014-01-01

    BACKGROUND: The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy

  3. Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents (BIONYX) : Rationale and design of the randomized TWENTE IV multicenter trial

    NARCIS (Netherlands)

    van der Heijden, Liefke C.; Kok, Marlies M.; Zocca, Paolo; Jessurun, Gillian A.J.; Schotborgh, Carl E.; Roguin, Ariel; Benit, Edouard; Aminian, Adel; Danse, Peter W.; Löwik, Marije M.; Linssen, Gerard C.M.; van der Palen, Job; Doggen, Carine J.M.; von Birgelen, Clemens

    2018-01-01

    Aim: The aim was to compare in a noninferiority trial the efficacy and safety of 2 contemporary drug-eluting stents (DESs): a novel, durable polymer-coated stent versus an established bioabsorbable polymer-coated stent. Methods and results: The BIONYX trial (ClinicalTrials.gov-no.NCT02508714) is an

  4. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Kyung

    2012-03-01

    Full Text Available Abstract Background Second-generation drug-eluting stents (DES have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES. In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI. A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES and antiplatelet regimen (TAT vs DDAT. The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734.

  5. A systematic review and meta-analysis of randomized trials and prospective studies comparing covered and bare self-expandable metal stents for the treatment of malignant obstruction in the digestive tract.

    Science.gov (United States)

    Yang, Zhiping; Wu, Qiong; Wang, Fang; Ye, Xiaofei; Qi, Xingshun; Fan, Daiming

    2013-01-01

    Self-expandable metal stents (SEMS) are widely used for the palliative treatment of malignant gastrointestinal obstruction. Our aim was to evaluate the evidence comparing covered and bare SEMS in the digestive tract using meta-analytical techniques. A literature search was performed using PubMed, Cochrane Library, and Embase databases for comparative studies assessing the two types of stents. The primary outcomes of interest were stent patency and patient survival; second outcomes included technical success, clinical success, tumor ingrowth, tumor overgrowth, and stent migration. A random-effects model was conducted. Pooled analysis was done separately based on the different segments of the digestive tract. Eleven studies (8 randomized controlled trials and 3 prospective cohort studies) including a total of 1376 patients were identified. Covered SEMS were equivalent to bare SEMS in terms of technical success, clinical success, stent patency (gastroduodenal obstruction: HR =0.87, 95% CI 0.53-1.42; colorectal obstruction: HR =0.89, 95% CI 0.18-4.45; biliary obstruction: HR =0.73, 95% CI 0.41-1.32) and survival rates (esophageal obstruction: HR =1.80, 95% CI 0.73-4.44; gastroduodenal obstruction: HR =0.83, 95% CI 0.55-1.26; biliary obstruction: HR =0.99, 95% CI 0.77-1.28), although bare stents were more prone to tumor ingrowth (esophageal obstruction: RR =0.10, 95% CI 0.01-0.77; gastroduodenal obstruction: RR =0.12, 95% CI 0.03-0.55; colorectal obstruction: RR =0.21, 95% CI 0.06-0.70; biliary obstruction: RR =0.21, 95% CI 0.06-0.69), whereas covered stents had the higher risk of stent migration (gastroduodenal obstruction: RR =5.01, 95% CI 1.53-16.43; colorectal obstruction: RR =11.70, 95% CI 2.84-48.27; biliary obstruction: RR =8.11, 95% CI 1.47-44.76) and tumor overgrowth (biliary obstruction: RR =2.03, 95% CI 1.08-3.78). Both covered and bare SEMS are comparable in efficacy for the palliative treatment of malignant obstruction in the digestive tract. Each type of

  6. Symptomatic stent cast.

    LENUS (Irish Health Repository)

    Keohane, John

    2012-02-03

    Biliary stent occlusion is a major complication of endoscopic stent insertion and results in repeat procedures. Various theories as to the etiology have been proposed, the most frequently studied is the attachment of gram negative bacteria within the stent. Several studies have shown prolongation of stent patency with antibiotic prophylaxis. We report the case of stent occlusion from a cast of a previously inserted straight biliary stent; a "stent cast" in an 86-year-old woman with obstructive jaundice. This was retrieved with the lithotrypter and she made an uneventful recovery. This is the first reported case of a biliary stent cast.

  7. Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents: main results of the Basel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination II (BASKET-PROVE II), a randomized, controlled noninferiority 2-year outcome trial.

    Science.gov (United States)

    Kaiser, Christoph; Galatius, Soeren; Jeger, Raban; Gilgen, Nicole; Skov Jensen, Jan; Naber, Christoph; Alber, Hannes; Wanitschek, Maria; Eberli, Franz; Kurz, David J; Pedrazzini, Giovanni; Moccetti, Tiziano; Rickli, Hans; Weilenmann, Daniel; Vuillomenet, André; Steiner, Martin; Von Felten, Stefanie; Vogt, Deborah R; Wadt Hansen, Kim; Rickenbacher, Peter; Conen, David; Müller, Christian; Buser, Peter; Hoffmann, Andreas; Pfisterer, Matthias

    2015-01-06

    Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear. To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES. In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. http://www.clinicaltrials.gov. Unique identifier: NCT01166685. © 2014 American Heart Association, Inc.

  8. Long-term prognostic value of risk scores after drug-eluting stent implantation for unprotected left main coronary artery: A pooled analysis of the ISAR-LEFT-MAIN and ISAR-LEFT-MAIN 2 randomized clinical trials.

    Science.gov (United States)

    Xhepa, Erion; Tada, Tomohisa; Kufner, Sebastian; Ndrepepa, Gjin; Byrne, Robert A; Kreutzer, Johanna; Ibrahim, Tareq; Tiroch, Klaus; Valgimigli, Marco; Tölg, Ralf; Cassese, Salvatore; Fusaro, Massimiliano; Schunkert, Heribert; Laugwitz, Karl L; Mehilli, Julinda; Kastrati, Adnan

    2017-01-01

    To evaluate the long-term prognostic value of risk scores in the setting of drug-eluting stent (DES) implantation for uLMCA. Data on the prognostic value of novel risk scores developed to select the most appropriate revascularization strategy in patients undergoing DES implantation for uLMCA disease are relatively limited. The study represents a patient-level pooled analysis of the ISAR-LEFT-MAIN (607 patients randomized to paclitaxel-eluting or sirolimus-eluting stents) and the ISAR-LEFT-MAIN-2 (650 patients randomized to everolimus-eluting or zotarolimus-eluting stents) randomized trials. The Syntax Score (SxScore) as well the Syntax Score II (SS-II), the EuroSCORE and the Global Risk Classification (GRC) were calculated. The primary outcome was all-cause mortality. At a mean follow-up of 3 years there were 160 deaths (12.7%). The death-incidence was significantly higher in the upper tertiles than in the intermediate or lower ones for all risk scores (log-rank test P risk scores were able to stratify the mortality risk at long-term follow-up. EuroSCORE was the only risk score that significantly improved the discriminatory power of a multivariable model to predict long-term mortality. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  9. Transanal stent in anterior resection does not prevent anastomotic leakage

    DEFF Research Database (Denmark)

    Bülow, Steffen; Bulut, O; Christensen, Ib Jarle

    2006-01-01

    OBJECTIVE: A defunctioning transanal stent may theoretically reduce the leakage rate after anterior rectal resection. We present a randomized open study with the aim of comparing the leakage rate after anterior resection with a loop ileostomy, a transanal stent, both or neither. PATIENTS...... completion of the operation the patients were randomized in two groups with and without a transanal stent. RESULTS: A clinically significant leakage was diagnosed in 25 patients (13%). No significant difference was found 17 of 98 patients with a stent and 8 of 96 without (P = 0.09), or in 9 of 44 ileostomy...... patients with a stent and in 3 of 45 without (P = 0.07). Several leaks over a short time led to an interim analysis after inclusion of 194 of 448 planned patients. The analysis showed no significant protective effect of the stent, and more leakages in the stent group, although not statistically significant...

  10. Stent Thrombosis is the Primary Cause of ST-Segment Elevation Myocardial Infarction following Coronary Stent Implantation

    DEFF Research Database (Denmark)

    Kristensen, Søren Lund; Galløe, Anders M; Thuesen, Leif

    2014-01-01

    Background: The widespread use of coronary stents has exposed a growing population to the risk of stent thrombosis, but the importance in terms of risk of ST-segment elevation myocardial infarctions (STEMIs) remains unclear. Methods: We studied five years follow-up data for 2,098 all-comer patients...... treated with coronary stents in the randomized SORT OUT II trial (mean age 63.6 yrs. 74.8% men). Patients who following stent implantation were readmitted with STEMI were included and each patient was categorized ranging from definite-to ruled-out stent thrombosis according to the Academic Research...... Consortium definitions. Multivariate logistic regression was performed on selected covariates to assess odds ratios (ORs) for definite stent thrombosis. Results: 85 patients (4.1%), mean age 62.7 years, 77.1% men, were admitted with a total of 96 STEMIs, of whom 60 (62.5%) had definite stent thrombosis...

  11. Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

    International Nuclear Information System (INIS)

    Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

    2013-01-01

    Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

  12. Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

    Energy Technology Data Exchange (ETDEWEB)

    Brodmann, Marianne, E-mail: marianne.brodmann@medunigraz.at; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz [Medical University of Graz, Division of Angiology (Austria); Deutschmann, Hannes [Medical University Graz, Division of Interventional Radiology (Austria); Seinost, Gerald; Pilger, Ernst [Medical University of Graz, Division of Angiology (Austria)

    2013-02-15

    Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

  13. Experimental use of new absorbable tracheal stent.

    Science.gov (United States)

    Schopf, Luciano F; Fraga, José Carlos; Porto, Rodrigo; Santos, Luis A; Marques, Douglas R; Sanchez, Paulo R; Meyer, Fabíola S; Ulbrich, Jane M

    2017-11-16

    Silicone and metallic stents are not effective in children with tracheobronchial stenosis or tracheomalacia. Herein, we aimed to evaluate the clinical manifestations and histological reaction of rabbit trachea to the presence of a new poly(lactic-co-glycolic acid) with polyisoprene (PLGA/PI) polymer absorbable stent. Fourteen adult white rabbits (weight, 3.0-3.5kg) were randomly assigned to three groups: Group I (n=6): PLGA/PI spiral stent; Group II (n=6): PLGA/PI fragment; and Group III (n=2): controls. After a longitudinal incision on three cervical tracheal rings, the stents and fragments were inserted into the trachea and fixed onto the lateral wall with nonabsorbable sutures. The stented group showed significantly more stridor at rest (p=0.0041), agitation (p=0.014), and use of accessory muscles (p=0.0002) and required more emergency endoscopies than the fragment group. Further, it showed significantly more remarkable histological inflammatory damage than the fragment and control groups (p=0.002). The new PLGA/PI polymeric stent implanted into the trachea of rabbits caused more clinical manifestations and histologically verified inflammatory reaction than the PLGA/PI polymeric fragment. Future studies should be aimed at reducing the stent-wall thickness. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Neointimal hyperplasia after silverhawk atherectomy versus percutaneous transluminal angioplasty (PTA) in femoropopliteal stent reobstructions: a controlled, randomized pilot trial.

    Science.gov (United States)

    Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

    2013-02-01

    Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

  15. Carotid Angioplasty and Stenting

    Science.gov (United States)

    Carotid angioplasty and stenting Overview Carotid angioplasty (kuh-ROT-id AN-jee-o-plas-tee) and stenting ... to better see and examine the blood vessels. Food and medications You'll receive instructions on what ...

  16. A critical assessment of the effects of tamsulosin and solifenacin as monotherapies and as a combination therapy for the treatment of ureteral stent-related symptoms: a 2 × 2 factorial randomized trial.

    Science.gov (United States)

    Park, Jinsung; Yoo, Changhee; Han, Deok Hyun; Shin, Dong Wook

    2015-11-01

    To assess the efficacy of tamsulosin, solifenacin, and combination therapy of both agents for the treatment of ureteral stent-related symptoms (SRSs). An open-label, randomized controlled trial was conducted with 112 patients who underwent unilateral ureteral stent insertion following ureteroscopic stone surgery. Patients were randomized with a 2 × 2 factorial design to one of four groups, i.e., A (control), B (tamsulosin 0.2 mg once daily), C (solifenacin 5 mg once daily), and D (both active treatments). Patients were evaluated at week 2 by the ureteral stent symptom questionnaire (USSQ). The primary efficacy outcome was the urinary symptom score of the USSQ, and the secondary efficacy outcomes were the scores in the other five USSQ domains, the Euro-QOL score, and oral analgesic requirements during the 2 weeks. Efficacy outcomes were primarily analyzed for the per-protocol set population. The four groups were generally well balanced in terms of baseline characteristics. Eighty-one patients (72.3 %) completed the study protocol. Comparison of the six USSQ domain scores at week 2 showed no differences between the four groups. Similarly, comparison of the domain scores stratified by tamsulosin or solifenacin medication showed no differences for either medication. The other secondary outcomes were also similar in the group comparisons. Neither tamsulosin nor solifenacin medications provide beneficial effects for relieving various SRSs. In addition, the combination therapy did not have beneficial effects. Further studies are warranted to determine the benefit of medical therapy for the treatment of SRSs and to determine the optimal management strategy for SRSs.

  17. OCT guidance during stent implantation in primary PCI: A randomized multicenter study with nine months of optical coherence tomography follow-up

    Czech Academy of Sciences Publication Activity Database

    Kala, P.; Červinka, P.; Jakl, M.; Kanovský, J.; Kupec, A.; Špaček, R.; Kvasnak, M.; Poloczek, M.; Červinková, M.; Bezerra, H.; Valenta, Zdeněk; Attizzani, G.; Schnell, A.; Hong, L.; Costa, M.

    2018-01-01

    Roč. 250, 1 January (2018), s. 98-103 ISSN 0167-5273 Institutional support: RVO:67985807 Keywords : optical coherence tomography * OCT * primary PCI * ST-segment elevation myocardial infarction * drug-eluting stents Subject RIV: FA - Cardiovascular Diseases incl. Cardiotharic Surgery Impact factor: 6.189, year: 2016

  18. Coronary bifurcation lesions treated with simple or complex stenting

    DEFF Research Database (Denmark)

    Behan, Miles W; Holm, Niels R; de Belder, Adam J

    2016-01-01

    AIMS: Randomized trials of coronary bifurcation stenting have shown better outcomes from a simple (provisional) strategy rather than a complex (planned two-stent) strategy in terms of short-term efficacy and safety. Here, we report the 5-year all-cause mortality based on pooled patient-level data...

  19. Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis.

    Science.gov (United States)

    Valgimigli, Marco; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Ferrante, Giuseppe

    2014-11-04

    To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported. Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death. The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; Pstents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis. © Valgimigli et al 2014.

  20. Complications related to conventional self-expandable metal stent insertion and internal irradiation stent insertion in patients with advanced esophageal carcinoma: an analysis of 32 cases

    International Nuclear Information System (INIS)

    Xu Xingwen; Di Haiting; Zhu Jun; Shi Jian

    2011-01-01

    Objective: To compare the occurrence of complications between conventional self-expandable metal stent and internal irradiation stent insertion in treating patients with advanced esophageal carcinomas. Methods: A total of 32 patients with advanced esophageal carcinoma were randomly divided into irradiation stent group (n=15) and conventional stent group (n=17). Internal irradiation stent loaded with 125 I seeds was employed in patients of irradiation stent group, while conventional self-expandable metal stent was used in patients of conventional stent group. After the treatment, clinical follow-up was regularly conducted. Postoperative complications such as fever, severe chest pain, cough, esophageal perforation, pneumonia, hemorrhage, stent migration and restenosis, etc. were observed. Results: No significant difference in the occurrence of fever, severe chest pain, esophageal perforation and hemorrhage existed between the two groups (P>0.05). The difference in the occurrence of long-term complications such as stent migration or restenosis between the two groups was out statistically significant (P>0.05). However, the restenosis in irradiation stent group occurred obviously much later than that in conventional stent group. Conclusion: For the treatment of advanced esophageal carcinomas, the insertion of internal irradiation esophageal stent is safe. It dose not increase the incidence of postoperative complications. Therefore, it is worth popularizing this technique in clinical practice. (authors)

  1. Bioabsorbable coronary stents--are these the next big thing in coronary angioplasty?

    Science.gov (United States)

    Balla, Sudarshan; Aggarwal, Kul; Nistala, Ravi

    2010-06-01

    The role of percutaneous coronary intervention (PCI) in the treatment of coronary artery disease has grown at an astronomical pace. Drug eluting stents (DES) offer advantages over bare metal stents (BMS) such as reduction in early in-stent restenosis rates. However, they have disadvantages like from increased late stent thrombosis when compared with BMS. Furthermore, recent data suggest endothelial dysfunction in the DES stented segments of the arteries. Currently, bioabsorbable stents are under development to avert the complications of DES such as stent thrombosis via degradation of the stent over time. The hypothetical advantage of leaving behind a natural vessel and restoring vasoreactivity may be the almost normal physiology which can be achieved after an intervention with a stent. The ABSORB and the PROGRESS AMS are two of the recent clinical trials that have looked at the outcomes of using bioabsorbable stents. So far, data from these and other studies has yielded mixed results in terms of angiographic and clinical outcomes. Newer stents such as REVA and WHISPER are presently being tested in preclinical and clinical trials. The landscape for bioabsorbable stents is constantly evolving through continued improvisation on existing technology and emergence of new technology. Large scale randomized trials are still needed with adequate long term follow-up for safety and benefits to have mainstream application in coronary artery disease, bioabsorbable stents are a promising innovation in the field of PCI. We review some of the patents and the data that is emerging on bioabsorbable stents in addition to currently ongoing clinical trials.

  2. Plastic or metal stents for benign extrahepatic biliary strictures: a systematic review

    Directory of Open Access Journals (Sweden)

    Vleggaar Frank P

    2009-12-01

    Full Text Available Abstract Background Benign biliary strictures may be a consequence of surgical procedures, chronic pancreatitis or iatrogenic injuries to the ampulla. Stents are increasingly being used for this indication, however it is not completely clear which stent type should be preferred. Methods A systematic review on stent placement for benign extrahepatic biliary strictures was performed after searching PubMed and EMBASE databases. Data were pooled and evaluated for technical success, clinical success and complications. Results In total, 47 studies (1116 patients on outcome of stent placement were identified. No randomized controlled trials (RCTs, one non-randomized comparative studies and 46 case series were found. Technical success was 98,9% for uncovered self-expandable metal stents (uSEMS, 94,8% for single plastic stents and 94,0% for multiple plastic stents. Overall clinical success rate was highest for placement of multiple plastic stents (94,3% followed by uSEMS (79,5% and single plastic stents (59.6%. Complications occurred more frequently with uSEMS (39.5% compared with single plastic stents (36.0% and multiple plastic stents (20,3%. Conclusion Based on clinical success and risk of complications, placement of multiple plastic stents is currently the best choice. The evolving role of cSEMS placement as a more patient friendly and cost effective treatment for benign biliary strictures needs further elucidation. There is a need for RCTs comparing different stent types for this indication.

  3. Comparison of a Simple Angiographic Approach With a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery Score-Based Approach for Left Main Coronary Artery Stenting: A Pooled Analysis of Serial PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) Studies.

    Science.gov (United States)

    Lee, Pil Hyung; Lee, Jong-Young; Lee, Cheol Whan; Kim, Seon-Ok; Ahn, Jung-Min; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Park, Seung-Jung

    2018-01-01

    The applicability of Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores to left main coronary artery disease (CAD) has been questioned. A simplified alternative is needed for guiding decision making. We evaluated the prognostic value of a simplified angiographic classification in comparison with a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score-based approach for patients with left main CAD undergoing drug-eluting stent implantation. The proposed approach classified left main CAD as either extensive (n=819), defined as left main bifurcation lesions with an involvement of ostial left circumflex artery or as any left main lesion plus multivessel CAD, or limited (n=453), defined as ostial/midshaft lesions or left main bifurcation lesions without an involvement of ostium of left circumflex artery, alone or plus 1-vessel disease. The databases from 4 prospective Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease studies were pooled, and the primary outcome was a major adverse cardiac event, defined as death, myocardial infarction, or repeat revascularization. During follow-up (median 38 months; interquartile range, 36-61 months), the risk for major adverse cardiac event was significantly higher with extensive than with limited left main CAD (adjusted hazard ratio, 2.13; 95% confidence interval, 1.54-2.94; P Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score tertiles did not effectively stratify these 2 outcome measures. Compared with Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores, the simpler angiographic approach provided better discrimination for future cardiovascular events in patients with left main CAD undergoing drug-eluting stent implantation. © 2018 American Heart Association, Inc.

  4. Circumferential Stent Fracture: Novel Detection and Treatment with the Use of StentBoost

    OpenAIRE

    Ramegowda, Raghu T.; Chikkaswamy, Srinivas B.; Bharatha, Ashalatha; Radhakrishna, Jayashree; Krishnanaik, Geetha B.; Nanjappa, Manjunath C.; Panneerselvam, Arunkumar

    2012-01-01

    Circumferential stent fracture is extremely uncommon, and in rare cases, it can cause stent thrombosis. Recognizing stent fracture can be difficult on conventional fluoroscopy because of poor stent radiopacity. We found that StentBoost image acquisition yields improved visibility of stent struts, enabling the identification of stent fracture and the precise positioning of new stents over previously stented segments.

  5. Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic Bifurcation Study III

    DEFF Research Database (Denmark)

    Niemelä, Matti; Kervinen, Kari; Erglis, Andrejs

    2011-01-01

    BACKGROUND: It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting......, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty...... angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed....

  6. Randomized Comparison of Final Kissing Balloon Dilatation Versus No Final Kissing Balloon Dilatation in Patients With Coronary Bifurcation Lesions Treated With Main Vessel Stenting. Five Year Clinical Outcome in The Nordic-Baltic Bifurcation Study III

    DEFF Research Database (Denmark)

    Niemelä, Matti; Holm, Niels R; Kervinen, Kari

    2015-01-01

    Background- It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting......, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty...... angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http...

  7. Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis.

    Science.gov (United States)

    Imaz-Iglesia, Iñaki; García-Pérez, Sonia; Nachtnebel, Anna; Martín-Águeda, Belén; Sánchez-Piedra, Carlos; Karadayi, Bilgehan; Demirbaş, Ali Rıza

    2016-06-01

    Esophageal stents are used for the treatment of refractory and recurrent dyphagias. In 2007, esophageal biodegradable stents (EBS) were authorised as an alternative to existing metal and plastic stents in Europe. The advantages claimed for EBS are fewer complications concerning tissue ingrowth, stent migration and stent removal. We performed a systematic review to evaluate the efficacy and safety of EBS compared to fully-covered self-expanding metal stents, self-expanding plastic stents, and esophageal dilation for the treatment of refractory or recurrent benign esophageal stenosis. Three comparative studies (one randomized controlled trial and two cohort studies) were assessed. The studies used different inclusion criteria, had a very small (sample) size and the quality of the evidence was very low. Expert commentary: The current evidence is insufficient to determine the relative efficacy or safety of esophageal biodegradable stents. The results of this systematic review should be updated once new evidence is available.

  8. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution

    Science.gov (United States)

    Coté, Gregory A.; Slivka, Adam; Tarnasky, Paul; Mullady, Daniel K.; Elmunzer, B. Joseph; Elta, Grace; Fogel, Evan; Lehman, Glen; McHenry, Lee; Romagnuolo, Joseph; Menon, Shyam; Siddiqui, Uzma D.; Watkins, James; Lynch, Sheryl; Denski, Cheryl; Xu, Huiping; Sherman, Stuart

    2017-01-01

    IMPORTANCE Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution. OBJECTIVE To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution. DESIGN, SETTING, AND PARTICIPANTS Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded. INTERVENTIONS Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence. MAIN OUTCOMES AND MEASURES Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of −15%. RESULTS There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, −3.0% to ∞; P stents was rejected. The mean number of ERCPs to achieve resolution

  9. Modified nasolacrimal duct stenting

    International Nuclear Information System (INIS)

    Tian Min; Jin Mei; Chen Huanjun; Li Yi

    2008-01-01

    Objective: Traditional nasolacrimal duct stenting possesses some shortcoming including difficulty of pulling ball head guide wire from the nasal cavity with turbinate hypertrophy and nasal septal deviation. The new method of nose-oral tube track establishment can overcome the forementioned and increase the successful rate. Methods: 5 F catheter and arterial sheath were modified to be nasolacrimal duct stent delivery device respectively. Antegrade dacryocystography was taken firstly to display the obstructed site and followed by the modified protocol of inserting the guide wire through nasolacrimal duct and nasal cavity, and establishing the stent delivery track for retrograde stent placement. Results: 5 epiphora patients with failure implantation by traditional method were all succeeded through the modified stenting (100%). During 6-mouth follow-up, no serious complications and reocclusion occurred. Conclusion: The establishment of eye-nose-mouth-nose of external nasal guide wire track can improve the successful rate of nasolacrimal duct stenting. (authors)

  10. Auxetic coronary stent endoprosthesis

    DEFF Research Database (Denmark)

    Amin, Faisal; Ali, Murtaza Najabat; Ansari, Umar

    2014-01-01

    BACKGROUND: Cardiovascular heart disease is one of the leading health issues in the present era and requires considerable health care resources to prevent it. The present study was focused on the development of a new coronary stent based on novel auxetic geometry which enables the stent to exhibit...... a negative Poisson's ratio. Commercially available coronary stents have isotropic properties, whereas the vascular system of the body shows anisotropic characteristics. This results in a mismatch between anisotropic-isotropic properties of the stent and arterial wall, and this in turn is not favorable...... for mechanical adhesion of the commercially available coronary stents with the arterial wall. It is believed that an auxetic coronary stent with inherent anisotropic mechanical properties and negative Poisson's ratio will have good mechanical adhesion with the arterial wall. METHODS: The auxetic design...

  11. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis.

    Science.gov (United States)

    Palmerini, Tullio; Biondi-Zoccai, Giuseppe; Della Riva, Diego; Stettler, Christoph; Sangiorgi, Diego; D'Ascenzo, Fabrizio; Kimura, Takeshi; Briguori, Carlo; Sabatè, Manel; Kim, Hyo-Soo; De Waha, Antoinette; Kedhi, Elvin; Smits, Pieter C; Kaiser, Christoph; Sardella, Gennaro; Marullo, Antonino; Kirtane, Ajay J; Leon, Martin B; Stone, Gregg W

    2012-04-14

    The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents. For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. 49 trials including 50,844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13-0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11-0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08-0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16-0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24-0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10-0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03-0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17-0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19-0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare

  12. Exclusion of Atherosclerotic Plaque from the Circulation Using Stent-Grafts: Alternative to Carotid Stenting with a Protection Device?

    International Nuclear Information System (INIS)

    Peynircioglu, Bora; Geyik, Serdar; Yavuz, Kivilcim; Cil, Barbaros E.; Saatci, Isil; Cekirge, Saruhan

    2007-01-01

    Purpose. To retrospectively assess the feasibility, safety, and clinical mid-term outcome of patients undergoing carotid artery stenting with stent-grafts. Methods. Over a 4 year period stent-grafts were used in the endovascular treatment of symptomatic internal carotid artery stenosis in 12 patients (2 women, 10 men, aged 47-83 (mean 64) years). Protection devices were not used. Possible microembolic complications were evaluated by magnetic resonance imaging (MRI) examinations of the brain before and the day after the procedure in all patients. Mean follow-up was 22 months (range 1-42 months), by Doppler ultrasonography and conventional angiography as well as clinical examination .Results. The technical success rate was 100%. A total of 13 coronary stent-grafts were used. The mean stenosis rate (in terms of diameter) was 85% and the mean length of stent-grafts used was 20.9 mm. The mean diameter to which the stent-grafts were dilated was 4.66 mm. In-hospital complications occurred in 1 patient who suffered a minor femoral access hematoma that did not require transfusion or surgical decompression. Post-stenting diffusion-weighted MRI revealed several ipsilateral silent microemboli in only 1 case, which was completely asymptomatic. Two patients had a major stroke after 2 years of follow-up. Restenosis was found in 2 patients who underwent successful balloon dilatation followed by placement of a self-expandable bare stent within the stent-grafts. Conclusions. Stent-grafts may prevent microembolic complications during stenting of atherosclerotic carotid lesions in selected cases, offering immediate exclusion of the atherosclerotic lesion from the circulation by pressing the plaque against the vessel wall. Comparative, randomized studies in larger series of patients are needed with carotid-dedicated stent-graft designs

  13. Five-year outcome after implantation of zotarolimus- and everolimus-eluting stents in randomized trial participants and nonenrolled eligible patients : A secondary analysis of a randomized clinical trial

    NARCIS (Netherlands)

    Von Birgelen, Clemens; Van Der Heijden, Liefke C.; Basalus, Mounir Welson Zakhary; Kok, Marlies M.; Sen, Hanim; Louwerenburg, Hans W.; van Houwelingen, Gert K.; Stoel, Martin G.; de Man, Frits H.A.F.; Linssen, Gerard C.M.; Tandjung, Kenneth; Doggen, Carine J.M.; Van Der Palen, Job; Löwik, Marije M.

    2017-01-01

    IMPORTANCE: Long-term follow-up after a clinical trial of 2 often-used, newer-generation drug-eluting stents (DESs) in a broad patient population is of interest. Comprehensive long-term outcome of eligible nonenrolled patients has never been reported. OBJECTIVE: To assess 5-year safety and efficacy

  14. Study design of the influence of SErotonin inhibition on patients with RENAl impairment or diabetes undergoing drug-eluting stent implantation (SERENADE) study: A multicenter, open-label, prospective, randomized study.

    Science.gov (United States)

    Lee, Seung-Ah; Suh, Jung-Won; Park, Jin Joo; Yoon, Chang-Hwan; Cho, Young-Suk; Youn, Tae-Jin; Chae, In-Ho; Kim, Hyo-Soo; Kim, Sang-Hyun; Choi, Dong-Ju

    2015-07-01

    The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation. The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment. The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643). Copyright © 2015. Published by Elsevier Inc.

  15. Immediate outcomes of eptifibatide therapy during intracoronary stent implantation.

    Science.gov (United States)

    Shariati, Hooman; Sanei, Hamid; Pourmoghadas, Ali; Salehizadeh, Leila; Amirpour, Afshin

    2016-01-01

    The objective of the present study was to assess the major immediate outcomes of eptifibatide therapy during intracoronary stent implantation. In an interventional study, patients undergoing percutaneous coronary intervention (PCI) were randomized into either the eptifibatide ( n = 100) or the control ( n = 107) group. In each group, demographic and clinical characteristics such as cardiac death, stent thrombosis (ST), myocardial infarction (MI), rates of target lesion and vessel revascularization, cerebral vascular accident (CVA), and emergency coronary artery bypass grafting (CABG) were recorded. The overall rates of major adverse events such as mortality, Stent thrombosis (ST), Myocardial Infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), CVA, and emergency CABG within 24 h after stent implantation were low and comparable between the two groups; P > 0.05 considered significant for all comparisons. There were no statistical differences between the clinical outcomes of groups administered with single-dose intracoronary eptifibatide and control groups among patients undergoing PCI during stent implantation.

  16. StentBoost Visualization for the Evaluation of Coronary Stent Expansion During Percutaneous Coronary Interventions

    OpenAIRE

    Cura, Fernando; Albertal, Mariano; Candiello, Alfonsina; Nau, Gerardo; Bonvini, Victor; Tricherri, Hernan; Padilla, Lucio T.; Belardi, Jorge A.

    2013-01-01

    Introduction Inadequate stent implantation is associated with stent thrombosis and restenosis. StentBoost can enhance stent visualization and evaluate stent expansion. Currently, there are limited comparison studies between StentBoost and intravascular ultrasound (IVUS). We aimed to test the correlation and agreement between IVUS and StentBoost measurements. Methods From December 2010 to December 2011, 38 patients (54 stents) were analyzed using IVUS and StentBoost. Minimal stent diameter and...

  17. Coronary Stents in Diabetic Patients: State of the Knowledge.

    Science.gov (United States)

    Codner, Pablo; Gurm, Hitinder Singh; Motivala, Apurva

    2017-04-01

    This review article aims to summarize the findings of the most relevant research that compared the use of paclitaxel vs. "limus" based drug eluting stent (DES) in diabetic patients and to define the current state of knowledge with new stent technologies in this patient population. Since drug eluting stents (DES) were introduced, it has been of great interest to establish whether paclitaxel or sirolimus eluting stents have the same safety and efficacy features for patients with coronary artery disease. The answer to this question is particularly relevant for diabetic patients. Several randomized trials, registry-based studies, and meta-analyses have assessed the performance of these different DES in diabetic patients. The most recently published data favors limus over paclitaxel DES in diabetic patients, but most of these studies compared first vs. second generation DES with the inherent caveats of comparing different platforms, alloys, and drug delivery vehicles. In this literature review, we found that there is robust evidence favoring the use of DES over bare metal stents in diabetic patients with coronary artery disease. We also found that the current state of knowledge is that the everolimus eluting stents have better safety and efficacy than paclitaxel eluting stents in diabetic patients and hence should be the preferred choice. New revascularization strategies including bio-absorbable scaffolds, polymer free stents, and bio-degradable polymers are being studied in diabetic patients with encouraging results.

  18. Predictors of early stent occlusion among plastic biliary stents.

    Science.gov (United States)

    Khashab, Mouen A; Kim, Katherine; Hutfless, Susan; Lennon, Anne Marie; Kalloo, Anthony N; Singh, Vikesh K

    2012-09-01

    A major disadvantage of plastic biliary stents is their short patency rates. The aim of this study was to identify predictors of early stent occlusion among patients receiving conventional plastic biliary stents. Early stent occlusion was defined as worsening cholestatic liver test results of a severity sufficiently significant to warrant ERCP with stent exchange prior to the planned stent exchange, or as symptoms of cholangitis. The association of cumulative stent diameter, demographics, stricture location, procedure indication, Charlson comorbidity index, history of prior early stent occlusion, presence of gallbladder, and performance of sphincteromy with the occurrence of early stent occlusion was studied using logistic regression and multivariate analysis. Our patient cohort comprised 343 patients (mean age 59.3 years) who underwent 561 ERCP procedures with the placement of one or more plastic biliary stents (mean number of stents per procedure 1.2, mean total diameter of stents per procedure 12 Fr). Early stent occlusion occurred in 73 (13 %) procedures. Female gender was protective against early stent occlusion (adjusted OR 0.54, 95 % CI 0.32-0.90, p = 0.02), while hilar stricture location was independently associated with a significantly increased risk of early stent occlusion (adjusted OR 3.41, 95 % CI 1.68-6.90, p = 0.0007). Early occlusion of conventional biliary stents occurred in 13 % of cases. While female gender decreased the risk of early stent occlusion, hilar stricture location was a significant predictor of early stent occlusion. Our results suggest that physicians should consider early elective stent exchange in patients with hilar strictures.

  19. Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated With Percutaneous Coronary Intervention: The Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV)

    DEFF Research Database (Denmark)

    Okkels Jensen, Lisette; Thayssen, Per; Hansen, Henrik Steen

    2012-01-01

    was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were.......71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0...

  20. Long-Term Safety of Drug-Eluting and Bare-Metal Stents

    DEFF Research Database (Denmark)

    Palmerini, Tullio; Benedetto, Umberto; Biondi-Zoccai, Giuseppe

    2015-01-01

    BACKGROUND: Previous meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety....... RESULTS: Fifty-one trials that included a total of 52,158 randomized patients with follow-up duration ≥3 years were analyzed. At a median follow-up of 3.8 years, cobalt-chromium everolimus-eluting stents (EES) were associated with lower rates of mortality, definite stent thrombosis (ST), and myocardial...... infarction than BMS, paclitaxel-eluting stents (PES), and sirolimus-eluting stents (SES) and less ST than BES. Phosphorylcholine-based zotarolimus-eluting stents had lower rates of definite ST than SES and lower rates of myocardial infarction than BMS and PES. The late rates of target...

  1. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial.

    Science.gov (United States)

    Sambola, Antonia; Montoro, J Bruno; Del Blanco, Bruno García; Llavero, Nadia; Barrabés, José A; Alfonso, Fernando; Bueno, Héctor; Cequier, Angel; Serra, Antonio; Zueco, Javier; Sabaté, Manel; Rodríguez-Leor, Oriol; García-Dorado, David

    2013-10-01

    Oral anticoagulation (OAC) is the recommended therapy for patients with atrial fibrillation (AF) because it reduces the risk of stroke and other thromboembolic events. Dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention and stenting (PCI-S). In patients with AF requiring PCI-S, the association of DAPT and OAC carries an increased risk of bleeding, whereas OAC therapy or DAPT alone may not protect against the risk of developing new ischemic or thromboembolic events. The MUSICA-2 study will test the hypothesis that DAPT compared with triple therapy (TT) in patients with nonvalvular AF at low-to-moderate risk of stroke (CHADS2 score ≤2) after PCI-S reduces the risk of bleeding and is not inferior to TT for preventing thromboembolic complications. The MUSICA-2 is a multicenter, open-label randomized trial that will compare TT with DAPT in patients with AF and CHADS2 score ≤2 undergoing PCI-S. The primary end point is the incidence of stroke or any systemic embolism or major adverse cardiac events: death, myocardial infarction, stent thrombosis, or target vessel revascularization at 1 year of PCI-S. The secondary end point is the combination of any cardiovascular event with major or minor bleeding at 1 year of PCI-S. The calculated sample size is 304 patients. The MUSICA-2 will attempt to determine the most effective and safe treatment in patients with nonvalvular AF and CHADS2 score ≤2 after PCI-S. Restricting TT for AF patients at high risk for stroke may reduce the incidence of bleeding without increasing the risk of thromboembolic complications. © 2013.

  2. Advantages and disadvantages of biodegradable platforms in drug eluting stents.

    Science.gov (United States)

    Rodriguez-Granillo, Agustina; Rubilar, Bibiana; Rodriguez-Granillo, Gaston; Rodriguez, Alfredo E

    2011-03-26

    Coronary angioplasty with drug-eluting stent (DES) implantation is currently the most common stent procedure worldwide. Since the introduction of DES, coronary restenosis as well as the incidence of target vessel and target lesion revascularization have been significantly reduced. However, the incidence of very late stent thrombosis beyond the first year after stent deployment has more commonly been linked to DES than to bare-metal stent (BMS) implantation. Several factors have been associated with very late stent thrombosis after DES implantation, such as delayed healing, inflammation, stent mal-apposition and endothelial dysfunction. Some of these adverse events were associated with the presence of durable polymers, which were essential to allow the elution of the immunosuppressive drug in the first DES designs. The introduction of erodable polymers in DES technology has provided the potential to complete the degradation of the polymer simultaneously or immediately after the release of the immunosuppressive drug, after which a BMS remains in place. Several DES designs with biodegradable (BIO) polymers have been introduced in preclinical and clinical studies, including randomized trials. In this review, we analyze the clinical results from 6 observational and randomized studies with BIO polymers and discuss advantages and disadvantages of this new technology.

  3. Spectral Imaging for Intracranial Stents and Stent Lumen.

    Science.gov (United States)

    Weng, Chi-Lun; Tseng, Ying-Chi; Chen, David Yen-Ting; Chen, Chi-Jen; Hsu, Hui-Ling

    2016-01-01

    Application of computed tomography for monitoring intracranial stents is limited because of stent-related artifacts. Our purpose was to evaluate the effect of gemstone spectral imaging on the intracranial stent and stent lumen. In vitro, we scanned Enterprise stent phantom and a stent-cheese complex using the gemstone spectral imaging protocol. Follow-up gemstone spectral images of 15 consecutive patients with placement of Enterprise from January 2013 to September 2014 were also retrospectively reviewed. We used 70-keV, 140-keV, iodine (water), iodine (calcium), and iodine (hydroxyapatite) images to evaluate their effect on the intracranial stent and stent lumen. Two regions of interest were individually placed in stent lumen and adjacent brain tissue. Contrast-to-noise ratio was measured to determine image quality. The maximal diameter of stent markers was also measured to evaluate stent-related artifact. Two radiologists independently graded the visibility of the lumen at the maker location by using a 4-point scale. The mean of grading score, contrast/noise ratio and maximal diameter of stent markers were compared among all modes. All results were analyzed by SPSS version 20. In vitro, iodine (water) images decreased metallic artifact of stent makers to the greatest degree. The most areas of cheese were observed on iodine (water) images. In vivo, iodine (water) images had the smallest average diameter of stent markers (0.33 ± 0.17mm; P stent lumen (160.03 ±37.79; P stent-related artifacts of Enterprise and enhance contrast of in-stent lumen. Spectral imaging may be considered a noninvasive modality for following-up patients with in-stent stenosis.

  4. Percutaneous Ureteral stent insertion

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Yup; Sung, Dong Wook; Choi, Woo Suk; Lee, Dong Ho; Ko, Young Tae; Lee, Sun Wha; Lim, Jae Hoon [Kyung Hee University Hospital, Seoul (Korea, Republic of)

    1990-10-15

    Percutaneous ureteral stent insertion is a treatment of permanent or temporary urinary diversion to maintain continuity and function of the obstructed and injured ureter. We performed 31 cases of percutaneous double pig tall ureteral stent insertion in 21 patients, included 13 patients with malignant ureteral obstruction and eight patients with injured ureter as well as benign inflammatory stricture. Satisfactory resulted was obtained in all patients but one, who need percutaneous nephrostomy on week later for urinary diversion. No significant complication was encountered. The authors concluded that percutaneous ureteral stent insertion, an interventional procedure alternative to urologic retrograde method, is an effective method for urinary diversion.

  5. Intravascular ultrasound assessed incomplete stent apposition and stent fracture in stent thrombosis after bare metal versus drug-eluting stent treatment the Nordic Intravascular Ultrasound Study (NIVUS)

    DEFF Research Database (Denmark)

    Kosonen, Petteri; Vikman, Saila; Jensen, Lisette Okkels

    2012-01-01

    This prospective multicenter registry used intravascular ultrasound (IVUS) in patients with definite stent thrombosis (ST) to compare rates of incomplete stent apposition (ISA), stent fracture and stent expansion in patients treated with drug-eluting (DES) versus bare metal (BMS) stents. ST...... is a rare, but potential life threatening event after coronary stent implantation. The etiology seems to be multifactorial....

  6. Covered versus uncovered self-expandable metal stents for malignant biliary strictures: A meta-analysis and systematic review.

    Science.gov (United States)

    Moole, Harsha; Bechtold, Matthew L; Cashman, Micheal; Volmar, Fritz H; Dhillon, Sonu; Forcione, David; Taneja, Deepak; Puli, Srinivas R

    2016-09-01

    Self-expandable metal stents (SEMS) are used for palliating inoperable malignant biliary strictures. It is unclear if covered metal stents are superior to uncovered metal stents in these patients. We compared clinical outcomes in patients with covered and uncovered stents. Studies using covered and uncovered metallic stents for palliation in patients with malignant biliary stricture were reviewed. Articles were searched in MEDLINE, PubMed, and Ovid journals. Fixed and random effects models were used to calculate the pooled proportions. Initial search identified 1436 reference articles, of which 132 were selected and reviewed. Thirteen studies (n = 2239) for covered and uncovered metallic stents which met the inclusion criteria were included in this analysis. Odds ratio for stent occlusion rates in covered vs. uncovered stents was 0.79 (95 % CI = 0.65 to 0.96). Survival benefit in patients with covered vs. uncovered stents showed the odds ratio to be 1.29 (95 % CI = 0.95 to 1.74). Pooled odds ratio for migration of covered vs. uncovered stents was 9.9 (95 % CI = 4.5 to 22.3). Covered stents seemed to have significantly lesser occlusion rates, increased odds of migration, and increased odds of pancreatitis compared to uncovered stents. There was no statistically significant difference in the survival benefit, overall adverse event rate, and patency period of covered vs. uncovered metal stents in patients with malignant biliary strictures.

  7. Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design

    DEFF Research Database (Denmark)

    Pfisterer, M.; Bertel, O.; Bonetti, P.O.

    2008-01-01

    or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with >= 3.0-mm stents only, randomized to receive Cypher (Johnson & Johnson, Miami Lakes, FL), Vision (Abbott Vascular, Abbott Laboratories, IL), or Xience stents (Abbott Vascular). Only...

  8. Percutaneous placement of ureteral stent

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Seung Hyup; Park, Jae Hyung; Han, Joon Koo; Han, Man Chung [Seoul National University College of Medicine, Seoul (Korea, Republic of)

    1990-12-15

    Antegrade placement of ureteral stents has successfully achieved in 41 of 46 ureters. When it was difficult to advance ureteral stents through the lesion, it was facilitated by retrograde guide-wire snare technique through urethra. Complications associated with the procedure were non-function of ureteral stent by occlusion, upward migration,and spontaneous fracture of ureteral stent. These complications were managed by percutaneous nephrostomy and removal of ureteral stents by guide-wire snare technique and insertion of a new ureteral stent. While blood cell in urine was markedly increased in about 50% of patients following the procedure.

  9. Drug-eluting stents to prevent stent thrombosis and restenosis.

    Science.gov (United States)

    Im, Eui; Hong, Myeong-Ki

    2016-01-01

    Although first-generation drug-eluting stents (DES) have significantly reduced the risk of in-stent restenosis, they have also increased the long-term risk of stent thrombosis. This safety concern directly triggered the development of new generation DES, with innovations in stent platforms, polymers, and anti-proliferative drugs. Stent platform materials have evolved from stainless steel to cobalt or platinum-chromium alloys with an improved strut design. Drug-carrying polymers have become biocompatible or biodegradable and even polymer-free DES were introduced. New limus-family drugs (such as everolimus, zotarolimus or biolimus) were adopted to enhance stent performances. As a result, these new DES demonstrated superior vascular healing responses on intracoronary imaging studies and lower stent thrombotic events in actual patients. Recently, fully-bioresorbable stents (scaffolds) have been introduced, and expanding their applications. In this article, the important concepts and clinical results of new generation DES and bioresorbable scaffolds are described.

  10. Drug eluting stents and modern stent technologies for in-stent restenosis.

    Science.gov (United States)

    Werner, Martin

    2017-08-01

    The implantation of metallic stents has become a standard procedure to improve the outcome after angioplasty of peripheral vessels. However, the occurrence of in-stent restenosis is hampering the long-term efficacy of these procedures and is associated with re-occurrence of symptoms. The optimal treatment modality for in-stent-restenosis in the peripheral vasculature is not well examined. This review discusses the existing evidence for the treatment of in-stent restenosis with drug eluting stents and modern stent technologies.

  11. Influence of covered stent versus bare stent on long-term efficacy of transjugular intrahepatic portosystemic shunt: a meta-analysis

    Directory of Open Access Journals (Sweden)

    XU Lu

    2016-10-01

    future, multicenter prospective randomized controlled clinical trials with a larger sample size are needed to provide a basis of evidence-based medicine for the application of covered stent in TIPS.

  12. The risk and prognostic impact of definite stent thrombosis or in-stent restenosis after coronary stent implantation

    DEFF Research Database (Denmark)

    Thayssen, Per; Jensen, Lisette Okkels; Lassen, Jens Flensted

    2012-01-01

    Aims: Data are limited on the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with coronary stents. We examined the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with percutaneous coronary intervention (PCI). Methods and results......: All patients who underwent stent implantation from 2002 to 2005 were identified in the Western Denmark Heart Registry. The hazard ratio (HR) for death associated with stent thrombosis or in-stent restenosis was estimated with a Cox regression analysis with stent thrombosis or in-stent restenosis...... as time-dependent variables. A total of 12,277 patients were treated with stent implantation. Stent thrombosis was observed in 111 (0.9%) patients and in-stent restenosis in 503 (4.1%) patients within 12 months after the index PCI. Occurrence of stent thrombosis was associated with an increased risk...

  13. Role of Esophageal Metal Stents Placement and Combination Therapy in Inoperable Esophageal Carcinoma: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Lai, Andrew; Lipka, Seth; Kumar, Ambuj; Sethi, Sajiv; Bromberg, David; Li, Nanxing; Shen, Huafeng; Stefaniwsky, Lilia; Brady, Patrick

    2018-04-01

    More than 50% of patients with esophageal cancer already have inoperable disease at the time of diagnosis. Controversy surrounds the outcomes of patients with advanced esophageal cancer who receive palliative care by either stent alone or stent plus an additional modality. We set out to perform a systematic review and meta-analysis of studies assessing the use of metal stents as treatment options for symptomatic improvement, survival, and adverse events. We searched Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception until January 14, 2016, as well as other databases for randomized controlled trials (RCTs) comparing esophageal stent versus either esophageal stent plus brachytherapy, radiotherapy, or chemotherapy. For quality assurance purposes throughout the systematic review, multiple independent extractions were performed, and the process was executed as per the standards of the Cochrane collaboration. Primary outcomes were mean change in dysphagia score, overall survival, and quality of life. Secondary outcomes were adverse events including fever, severe pain, aspiration, fistula, stent migration, perforation, and restenosis. Eight RCTs enrolling 732 patients were included with three distinct comparisons: stents combination therapy vs stents alone (5 studies, n = 417), stents alone versus brachytherapy alone (2 studies, n = 274), and stents + brachytherapy vs brachytherapy alone (1 study, n = 41). Stents combination therapy was defined as stents plus radiotherapy, chemotherapy, or both. Mean change in dysphagia scores favored stents combination therapy versus stents alone, and the effect was seen in patients surviving longer than 3 months. Stents combination therapy was also associated with a more favorable overall survival. The risks of stent migration, aspiration pneumonia, and restenosis were lower in the stents combination group compared to stents alone, while the risks of severe pain, hemorrhage, and

  14. Future developments in biliary stenting

    Science.gov (United States)

    Hair, Clark D; Sejpal, Divyesh V

    2013-01-01

    Biliary stenting has evolved dramatically over the past 30 years. Advancements in stent design have led to prolonged patency and improved efficacy. However, biliary stenting is still affected by occlusion, migration, anatomical difficulties, and the need for repeat procedures. Multiple novel plastic biliary stent designs have recently been introduced with the primary goals of reduced migration and improved ease of placement. Self-expandable bioabsorbable stents are currently being investigated in animal models. Although not US Food and Drug Administration approved for benign disease, fully covered self-expandable metal stents are increasingly being used in a variety of benign biliary conditions. In malignant disease, developments are being made to improve ease of placement and stent patency for both hilar and distal biliary strictures. The purpose of this review is to describe recent developments and future directions of biliary stenting. PMID:23837001

  15. Future developments in biliary stenting

    Directory of Open Access Journals (Sweden)

    Hair CD

    2013-06-01

    Full Text Available Clark D Hair,1 Divyesh V Sejpal21Department of Medicine, Section of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, TX, USA; 2Department of Medicine, Section of Gastroenterology, Hofstra North Shore-LIJ School of Medicine, North Shore University Hospital, Manhasset, NY, USAAbstract: Biliary stenting has evolved dramatically over the past 30 years. Advancements in stent design have led to prolonged patency and improved efficacy. However, biliary stenting is still affected by occlusion, migration, anatomical difficulties, and the need for repeat procedures. Multiple novel plastic biliary stent designs have recently been introduced with the primary goals of reduced migration and improved ease of placement. Self-expandable bioabsorbable stents are currently being investigated in animal models. Although not US Food and Drug Administration approved for benign disease, fully covered self-expandable metal stents are increasingly being used in a variety of benign biliary conditions. In malignant disease, developments are being made to improve ease of placement and stent patency for both hilar and distal biliary strictures. The purpose of this review is to describe recent developments and future directions of biliary stenting.Keywords: plastic stents, self-expandable metal stents, drug eluting stents, bioabsorbable stents, malignant biliary strictures, benign biliary strictures

  16. Stent Thrombosis With Drug-Eluting Stents and Bioresorbable Scaffolds: Evidence From a Network Meta-Analysis of 147 Trials.

    Science.gov (United States)

    Kang, Si-Hyuck; Chae, In-Ho; Park, Jin-Joo; Lee, Hak Seung; Kang, Do-Yoon; Hwang, Seung-Sik; Youn, Tae-Jin; Kim, Hyo-Soo

    2016-06-27

    This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS. To improve outcomes of patients undergoing percutaneous coronary revascularization, there have been advances in the design of drug-eluting stents (DES), including the development of drug-eluting bioresorbable vascular scaffolds (BVS). Prospective, randomized, controlled trials comparing bare-metal stents (BMS), paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), Endeavor zotarolimus-eluting stents (E-ZES), cobalt-chromium (CoCr) everolimus-eluting stents (EES), platinum-chromium (PtCr)-EES, biodegradable polymer (BP)-EES, Resolute zotarolimus-eluting stents (R-ZES), BP biolimus-eluting stents (BP-BES), hybrid sirolimus-eluting stents (H [Orsiro]-SES), polymer-free sirolimus- and probucol-eluting stents, or BVS were searched in online databases. The primary endpoint was definite or probable stent thrombosis at 1 year. A total of 147 trials including 126,526 patients were analyzed in this study. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. CoCr-EES, PtCr-EES, and H-SES were associated with significantly lower risk than BVS. CoCr-EES and H-SES were superior to SES and BP-BES. The risk of myocardial infarction was significantly lower with H-SES than with BVS. There were no significant differences regarding all-cause or cardiac mortality. Contemporary devices including BVS showed comparably low risks of repeat revascularization. Contemporary DES, including biocompatible DP-DES, BP-DES, and polymer-free DES, showed a low risk of definite or probable stent thrombosis at 1 year. BVS had an increased risk of device thrombosis compared with CoCr-EES, PtCr-EES, and H-SES. Data from extended follow-up are warranted to confirm the long-term safety of contemporary coronary devices. Copyright © 2016 American College of Cardiology Foundation. Published by

  17. The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent

    Directory of Open Access Journals (Sweden)

    Cristina Lucía Dávila-Fajardo

    2017-02-01

    Full Text Available This article contains data related to the research article entitled “Results of genotype–guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent” (J. Sánchez-Ramos, C.L. Dávila-Fajardo, P. Toledo Frías, X. Díaz Villamarín, L.J. Martínez-González, S. Martínez Huertas, F. Burillo Gómez, J. Caballero Borrego, A. Bautista Pavés, M.C. Marín Guzmán, J.A. Ramirez Hernández, C. Correa Vilches, J. Cabeza Barrera, 2016 (1. This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype–guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up, study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33.

  18. Biodegradable stents in benign stenosis of the esophagus

    International Nuclear Information System (INIS)

    Manova, G.

    2013-01-01

    Full text: Introduction: Benign stenosis of the esophagus can be postcorrosion peptic or postoperative. The treatment is difficult and traditionally consists of multiple dilatations. In refractory stenosis the placement of metal self-expanding stents is disputed because requiring their subsequent removal. New experience for therapeutic decision is self- degradable stents. Manipulation is a single and not requires their removal. What you will learn: Patients indicated for the treatment with self- degradable stents are with benign stenosis not suitable for balloon dilatation or bougienage dilation. The main groups are those with postcorrosion stenosis, peptic stenosis due to untreated gastroesophageal reflux disease with different prescription as well as post-surgical and post-radiation stenosis. Self-expanding stents made by monofilament polymer of polydioxanone, whose integrity and radial force remain 6-8 weeks depending on the gastric pH are used. Stents are applied in hard guide placed in the stenosis through the working channel of gastroscopy, and they are released under X-ray control. Putting is preceded by balloon dilatation due to the large diameter of the mounted stent. During the manipulations, several difficulties are encountered, which are missing in self-expanding metal stents. Discussion: Short-term results are satisfactory - Dysphagia in the patients is overcome and they recover their normal diet. The patients reported no pain. The control inspection of the 1st month showed partial degradation of the stents. On 3rd month it is set the complete degradation. Term follow-up shows resumption of dysphagia. Conclusion: Good short-term results make the use of self-degradable stents possible alternative for the treatment of the esophagus refractory stenosis. Long-term results are contradictory, still missing long enough randomized studies on this topic

  19. Heterogeneous Intravascular Ultrasound Findings of Stent Thrombosis

    OpenAIRE

    Morofuji, Toru; Inaba, Shinji; Aisu, Hiroe; Takahashi, Kayo; Saito, Makoto; Higashi, Haruhiko; Yoshii, Toyofumi; Sumimoto, Takumi

    2017-01-01

    Objective The underlying mechanisms of stent thrombosis are not completely understood. Methods We experienced 12 definite stent thrombosis cases (1 early, 1 late, and 10 very late) at our hospital from July 2011 to April 2016 and evaluated the possible causes of stent thrombosis by intravascular ultrasound (IVUS). Results Five different potential morphological causes of stent thrombosis (neoatherosclerosis, stent malapposition, stent fracture, edge dissection, and stent underexpansion) were d...

  20. Role of Tamsulosin in Improving Double-J Ureteric Stent-Related ...

    African Journals Online (AJOL)

    Objective: To evaluate the efficacy of tamsulosin in improving stent- related symptoms and quality of life (QoL) in patients with double-J (DJ) ureteric stents. Subjects and Methods: A total of 136 patients were prospectively evaluated and distributed randomly in two groups. Group 1 was 69 patients with mean age 35 years ...

  1. Stent sizing strategies in renal artery stenting: the comparison of conventional invasive renal angiography with renal computed tomographic angiography.

    Science.gov (United States)

    Kadziela, Jacek; Michalowska, Ilona; Pregowski, Jerzy; Janaszek-Sitkowska, Hanna; Lech, Katarzyna; Kabat, Marek; Staruch, Adam; Januszewicz, Andrzej; Witkowski, Adam

    2016-01-01

    Randomized trials comparing invasive treatment of renal artery stenosis with standard pharmacotherapy did not show substantial benefit from revascularization. One of the potential reasons for that may be suboptimal procedure technique. To compare renal stent sizing using two modalities: three-dimensional renal computed tomography angiography (CTA) versus conventional angiography. Forty patients (41 renal arteries), aged 65.1 ±8.5 years, who underwent renal artery stenting with preprocedural CTA performed within 6 months, were retrospectively analyzed. In CTA analysis, reference diameter (CTA-D) and lesion length (CTA_LL) were measured and proposed stent diameter and length were recorded. Similarly, angiographic reference diameter (ANGIO_D) and lesion length (ANGIO_LL) as well as proposed stent dimensions were obtained by visual estimation. The median CTA_D was 0.5 mm larger than the median ANGIO_D (p < 0.001). Also, the proposed stent diameter in CTA evaluation was 0.5 mm larger than that in angiography (p < 0.0001). The median CTA_LL was 1 mm longer than the ANGIO_LL (p = NS), with significant correlation of these variables (r = 0.66, p < 0.0001). The median proposed stent length with CTA was equal to that proposed with angiography. The median diameter of the implanted stent was 0.5 mm smaller than that proposed in CTA (p < 0.0005) and identical to that proposed in angiography. The median length of the actual stent was longer than that proposed in angiography (p = 0.0001). Renal CTA has potential advantages as a tool adjunctive to angiography in appropriate stent sizing. Careful evaluation of the available CTA scans may be beneficial and should be considered prior to the planned procedure.

  2. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

    DEFF Research Database (Denmark)

    Urban, Philip; Meredith, Ian T; Abizaid, Alexandre

    2015-01-01

    BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9......), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual...... ratio, 0.50; 95% CI, 0.37 to 0.69; Pbleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet...

  3. Oversizing and Restenosis with Self-Expanding Stents in Iliofemoral Arteries

    International Nuclear Information System (INIS)

    Saguner, Ardan M.; Traupe, Tobias; Räber, Lorenz; Hess, Nina; Banz, Yara; Saguner, Arhan R.; Diehm, Nicolas; Hess, Otto M.

    2012-01-01

    Purpose: Uncoated self-expanding nitinol stents (NS) are commonly oversized in peripheral arteries. In current practice, 1-mm oversizing is recommended. Yet, oversizing of NS may be associated with increased restenosis. To provide further evidence, NS were implanted in porcine iliofemoral arteries with a stent-to-artery-ratio between 1.0 and 2.3. Besides conventional uncoated NS, a novel self-expanding NS with an antiproliferative titanium-nitride-oxide (TiNOX) coating was tested for safety and efficacy. Methods: Ten uncoated NS and six TiNOX-coated NS (5–6 mm) were implanted randomly in the iliofemoral artery of six mini-pigs. After implantation, quantitative angiography (QA) was performed for calculation of artery and minimal luminal diameter. Follow-up was performed by QA and histomorphometry after 5 months. Results: Stent migration, stent fracture, or thrombus formation were not observed. All stents were patent at follow-up. Based on the location of the stent (iliac/femoral) and the stent-to-artery-ratio, stent segments were divided into “normal-sized” (stent-to-artery-ratio < 1.4, n = 12) and “oversized” (stent-to-artery-ratio ≥ 1.4, n = 9). All stent segments expanded to their near nominal diameter during follow-up. Normal-sized stent segments increased their diameter by 6% and oversized segments by 29%. A significant correlation between oversizing and restenosis by both angiography and histomorphometry was observed. Restenosis rates were similar for uncoated NS and TiNOX-coated NS. Conclusions: TiNOX-coated NS are as safe and effective as uncoated NS in the porcine iliofemoral artery. All stents further expand to near their nominal diameter during follow-up. Oversizing is linearly and positively correlated with neointimal proliferation and restenosis, which may not be reduced by TiNOX-coating.

  4. Transanal stent in anterior resection does not prevent anastomotic leakage

    DEFF Research Database (Denmark)

    Bülow, Steffen; Bulut, O; Christensen, Ib Jarle

    2006-01-01

    OBJECTIVE: A defunctioning transanal stent may theoretically reduce the leakage rate after anterior rectal resection. We present a randomized open study with the aim of comparing the leakage rate after anterior resection with a loop ileostomy, a transanal stent, both or neither. PATIENTS AND METH....... On this basis it was decided to discontinue the study prematurely for ethical reasons. CONCLUSION: Decompression of the anastomosis with a transanal stent does not reduce the risk of anastomotic leakage after anterior resection.......OBJECTIVE: A defunctioning transanal stent may theoretically reduce the leakage rate after anterior rectal resection. We present a randomized open study with the aim of comparing the leakage rate after anterior resection with a loop ileostomy, a transanal stent, both or neither. PATIENTS...... AND METHODS: Randomized open trial of 194 patients operated in 11 hospitals during September 2000 to September 2003 with anterior resection for a mobile rectal tumour, 115 men and 79 women, median age 68 years (range 37-90 years). The surgeon decided upon the use of a protective ileostomy, and after...

  5. 'Stent in a stent'--an alternative technique for removing partially covered stents following sleeve gastrectomy complications.

    Science.gov (United States)

    Vasilikostas, Georgios; Sanmugalingam, Nimalan; Khan, Omar; Reddy, Marcus; Groves, Chris; Wan, Andrew

    2014-03-01

    Endoscopic stenting is a relatively new technique for the treatment of post sleeve gastrectomy complications. Partially covered stents are used in this method to minimise the risk of migration but they are associated with difficulties with removal. Patients requiring emergency stenting following sleeve gastrectomy underwent insertion of a partially covered metallic stent. One month later, if the stent was not easily removable, a fully covered overlapping stent was inserted and the patient was readmitted 2 weeks later for removal of both stents. Four patients required stenting following sleeve gastrectomy leaks, and one patient required stenting for a stricture. In these cases, a 'stent in a stent' technique was used for removal. This technique allows the safe removal of partially covered stents inserted following sleeve gastrectomy complications.

  6. Impact of polymer formulations on neointimal proliferation after zotarolimus-eluting stent with different polymers: insights from the RESOLUTE trial.

    Science.gov (United States)

    Waseda, Katsuhisa; Ako, Junya; Yamasaki, Masao; Koizumi, Tomomi; Sakurai, Ryota; Hongo, Yoichiro; Koo, Bon-Kwon; Ormiston, John; Worthley, Stephen G; Whitbourn, Robert J; Walters, Darren L; Meredith, Ian T; Fitzgerald, Peter J; Honda, Yasuhiro

    2011-06-01

    Polymer formulation may affect the efficacy of drug-eluting stents. Resolute, Endeavor, and ZoMaxx are zotarolimus-eluting stents with different stent platforms and different polymer coatings and have been tested in clinical trials. The aim of this analysis was to compare the efficacy of zotarolimus-eluting stents with different polymers. Data were obtained from the first-in man trial or first randomized trials of each stent, The Clinical RESpOnse EvaLUation of the MedTronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (RESOLUTE), Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions (ENDEAVOR II), and ZoMaxx I trials. Follow-up intravascular ultrasound analyses (8 to 9 months of follow-up) were possible in 353 patients (Resolute: 88, Endeavor: 98, ZoMaxx: 82, Driver: 85). Volume index (volume/stent length) was obtained for vessel, stent, lumen, peristent plaque, and neointima. Cross-sectional narrowing was defined as neointimal area divided by stent area (%). Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. At baseline, vessel, lumen, and peristent plaque volume index were not significantly different among the 4 stent groups. At follow-up, percent neointimal obstruction was significantly lower in Resolute compared with Endeavor, ZoMaxx, and Driver (Resolute: 3.7±4.0, Endeavor: 17.5±10.1, ZoMaxx: 14.6±8.1, Driver: 29.4±17.2%; Ppolymer used in Resolute independently correlated with neointimal suppression among 3 zotarolimus-eluting stents. The different polymer formulations significantly affect the relative amount of neointima for zotarolimus-eluting stents. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00248079.

  7. Angioplasty and stent placement - carotid artery

    Science.gov (United States)

    ... medlineplus.gov/ency/article/002953.htm Angioplasty and stent placement - carotid artery To use the sharing features ... to remove plaque buildup ( endarterectomy ) Carotid angioplasty with stent placement Description Carotid angioplasty and stenting (CAS) is ...

  8. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial.

    Science.gov (United States)

    de Winter, Robbert J; Katagiri, Yuki; Asano, Taku; Milewski, Krzysztof P; Lurz, Philipp; Buszman, Pawel; Jessurun, Gillian A J; Koch, Karel T; Troquay, Roland P T; Hamer, Bas J B; Ophuis, Ton Oude; Wöhrle, Jochen; Wyderka, Rafał; Cayla, Guillaume; Hofma, Sjoerd H; Levesque, Sébastien; Żurakowski, Aleksander; Fischer, Dieter; Kośmider, Maciej; Goube, Pascal; Arkenbout, E Karin; Noutsias, Michel; Ferrari, Markus W; Onuma, Yoshinobu; Wijns, William; Serruys, Patrick W

    2018-02-03

    MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45

  9. Influence of 103Pd radioactive stent on apoptosis of vascular smooth muscle cells

    International Nuclear Information System (INIS)

    Liu Yingmei; Wu Wei; Chen Xiaochao; Zhang Xuming; Wang Jingfeng; Wei Yulin; Yang Li

    2003-01-01

    Objective: To evaluate the influence of 103 Pd radioactive stent on apoptosis and its relative genes bcl-2 and bax in injured vascular media smooth muscle cells of rabbit abdominal arteries and to investigate the mechanism of 103 Pd radioactive stent for preventing restenosis after angioplasty. Methods: Fifty male New Zealand rabbits were randomized into stent group and 103 Pd stent group. Each group was subdivided into 5 sub-groups. Control group was set up. The study arteries were harvested at 3, 7, 14, 28 and 56 d after stenting and the pathomorphology, apoptosis analysis and in situ hybridization were performed to evaluate the expression of bcl-2 and bax mRNA. Results: The severity of the restenosis in 103 Pd stent group was less than that of stent group. It was most obvious at the 56th day (P 103 Pd stent group had much more apoptosis of vascular smooth muscle cells than stent group did and reached the peak at the 7th day, (14.72±0.53)% vs (12.42±1.13)% (P 103 Pd stent group was much lower than that of stent group at 3 to 28 d. The difference was most obvious at the 28th day after stenting, (18.43± 0.67)% vs (21.55±0.93)% (P 103 Pd stent group was higher than that of stent group, the peak was at the 7th day, (11.17±0.94)% vs (9.30±1.01)%. The ratio of bcl-2/bax in 103 Pd stent group was much lower than that of stent group at 3 to 28 d. Linear correlation analysis showed that there was significant negative correlation between bcl-2 mRNA and apoptosis. Between bax mRNA and apoptosis, the positive correlation was found (P 103 Pd radioactive stent induced more significant apoptosis in vascular media smooth muscle cells by promoting the expression of apoptosis related genes and relieved the expanding of restenosis

  10. Self-expandable metalic endotracheal stent

    International Nuclear Information System (INIS)

    Do, Young Soo; Cho, Dae Soon; Cho, Kyung Ja; Lee, Young Soo; Lee, Mi Jae

    1993-01-01

    Six bare stents and six covered stents were inserted in the trachea of 12 dogs under general anesthesia. After 1-10 weeks of observation, the dogs were killed, and the trachea and lung were examined grossly and histologically. Pneumonia and stent migration were observed more frequently at covered stent group. Inflammatory change of the trachea was more severe at covered stent group. In conclusion, we believe that it is inadequate to insert silicone covered stent in the tracheobronchial tree. (Author)

  11. Self-expandable metalic endotracheal stent

    Energy Technology Data Exchange (ETDEWEB)

    Do, Young Soo; Cho, Dae Soon; Cho, Kyung Ja; Lee, Young Soo; Lee, Mi Jae [Korea Cancer Center Hospital, Seoul (Korea, Republic of)

    1993-01-01

    Six bare stents and six covered stents were inserted in the trachea of 12 dogs under general anesthesia. After 1-10 weeks of observation, the dogs were killed, and the trachea and lung were examined grossly and histologically. Pneumonia and stent migration were observed more frequently at covered stent group. Inflammatory change of the trachea was more severe at covered stent group. In conclusion, we believe that it is inadequate to insert silicone covered stent in the tracheobronchial tree. (Author).

  12. Experimental study of 103Pd stents for preventing the restenosis of biliary duct

    International Nuclear Information System (INIS)

    Gao Qinyi; Shu Qiang; Lu Xiangdong; Li Yaming; He Guijin; Pei Zhuguo; Xu Shuhe

    2004-01-01

    Objective: To explore the feasibility of preventing biliary duct restenosis with the stent treated with 103 Pd and to elucidate the mechanisms of the inhibition of the smooth muscle cell proliferation and the increase of apoptosis. Methods: The experimental dogs were randomly divided into common-stent group and 103 Pd stent group, each of 6 animals. Pathohistology, cell apoptosis, immunohistochemistry for proliferating cell nuclear antigen (PCNA), the expression of gene p53 by in situs hybridization, the test of the peripheral blood and measurement of radiation of tissue around the stent were studied. Results: The utmost intimal thickness of biliary duct in the 103 Pd stent group was found to be obviously less compared to that in common-stent group after 30 d, the percentages of the stenosis of the biliary duct were (54.73 ± 21.64)% and (17.61 ± 14.52)%, respectively, there was a significant difference between two groups (P 103 Pd stent group, and decreased in the common-stent group; the expression of PCNA of biliary smooth muscle cells of 103 Pd group was weaker compared with that in the common-group. Conclusion: 103 Pd stent may inhibit the proliferation of smooth muscle cells and prevent the restenosis of biliary duct. (authors)

  13. Delayed complications after flow-diverter stenting: reactive in-stent stenosis and creeping stents.

    Science.gov (United States)

    Cohen, José E; Gomori, John Moshe; Moscovici, Samuel; Leker, Ronen R; Itshayek, Eyal

    2014-07-01

    We assessed the frequency and severity of changes in stent configuration and location after the treatment of intracranial aneurysms, and patterns of in-stent stenosis. We retrospectively reviewed data for consecutive aneurysm patients managed with endovascular implantation of flow-diverter stents (Silk Flow Diverter [Balt Extrusion, Montmorency, France] and Pipeline Embolization Device [ev3/Coviden, Minneapolis, MN, USA]) from October 2011 to July 2012. Routine 2, 6, 9-12, and 16-20 month follow-up angiograms were compared, with a focus on changes in stent configuration and location from immediately after deployment to angiographic follow-up, and the incidence and development of in-stent stenosis. Thirty-four patients with 42 aneurysms met inclusion criteria. The Silk device was implanted in 16 patients (47%, single device in 15), the Pipeline device in 18 (53%, single device in 16). On first follow-up angiography, in-stent stenosis was observed in 38% of Silk devices and 39% of Pipeline devices. In-stent stenosis was asymptomatic in 12 of 13 patients. One woman presented with transient ischemic attacks and required stent angioplasty due to end tapering and mild, diffuse in-stent stenosis. Configuration and location changes, including stent creeping and end tapering were seen in 2/16 patients (13%) with Silk devices, and 0/18 patients with Pipeline devices. We describe stent creeping and end tapering as unusual findings with the potential for delayed clinical complications. In-stent stenosis, with a unique behavior, is a frequent angiographic finding observed after flow-diverter stent implant. The stenosis is usually asymptomatic; however, close clinical and angiographic monitoring is mandatory for individualized management. Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. Angioplasty and stent - heart - discharge

    Science.gov (United States)

    Drug-eluting stents - discharge; PCI - discharge; Percutaneous coronary intervention - discharge; Balloon angioplasty - discharge; Coronary angioplasty - discharge; Coronary artery angioplasty - discharge; Cardiac ...

  15. Indications for stenting during thrombolysis

    DEFF Research Database (Denmark)

    Bækgaard, N; Broholm, R; Just, Sven Richardt Lundgren

    2013-01-01

    of a stent in this position is the treatment of choice facilitating the venous flow into an unobstructed outflow tract either from the femoral vein or the deep femoral vein or both. The stent, made of stainless steel or nitinol, has to be self-expandable and flexible with radial force to overcome...... the challenges in this low-pressure system. The characteristics of the anatomy with external compression and often a curved vein segment with diameter difference make stent placement necessary. Ballooning alone has no place in this area. The proportion of inserted stents varies in the published materials...

  16. Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials.

    Science.gov (United States)

    Sawaya, Fadi J; Morice, Marie-Claude; Spaziano, Marco; Mehran, Roxana; Didier, Romain; Roy, Andrew; Valgimigli, Marco; Kim, Hyo-Soo; Woo Park, Kyung; Hong, Myeong-Ki; Kim, Byeong-Keuk; Jang, Yangsoo; Feres, Fausto; Abizaid, Alexandre; Costa, Ricardo A; Colombo, Antonio; Chieffo, Alaide; Giustino, Gennaro; Stone, Gregg W; Bhatt, Deepak L; Palmerini, Tullio; Gilard, Martine

    2017-02-01

    Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short- (≤6 months) versus long-term (≥1 year) DAPT after drug-eluting stent (DES) placement in women and men. We pooled individual patient data from 6 randomized trials of DAPT (EXCELLENT, OPTIMIZE, PRODIGY, RESET, SECURITY, ITALIC PLUS). The primary outcome was 1-year risk of major adverse cardiac events (MACE). The main secondary outcome was 1-year risk of any bleeding. Out of the 11,473 randomized patients included in the pooled dataset, 3,454 (30%) were females. At 1-year follow-up, women had higher risk of MACE (3.6% vs. 2.8%; P = 0.01) but similar risk of bleeding (1.9% vs. 1.6%; P = 0.16) as compared with men. Compared with long-term DAPT, short-term DAPT was associated with similar rates of MACE in both women (HR 0.88; 95% CI 0.62-1.25) and men (HR 1.25; 95% CI 0.95-1.6; P interaction = 0.08)]. At 1-year follow-up, short-term DAPT was associated with lower rates of bleeding as compared with long-term DAPT in both women (HR 0.84; 95% CI 0.51-1.37) and men (HR 0.58; 95% CI 0.40-0.84; P-interaction = 0.25). The presence of MVD was associated with higher MACE rates in the short-term DAPT group in women (HR: 1.16; CI 0.60-2.23) and men (HR: 2.29; CI 1.22-4.29; P interaction = 0.25). Short-term DAPT is associated with similar rates of MACE but lower risk of bleeding when as compared with prolonged DAPT. There was no significant difference between sexes in the population studied. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  17. The stenting strategy of drug-eluting stents for coronary artery disease in patients on dialysis

    Directory of Open Access Journals (Sweden)

    Hiroshi Fujita

    2014-12-01

    Full Text Available Background: Reports regarding the relationship between the length and diameter of implanted drug-eluting stents and clinical and angiographic outcomes in dialysis patients are limited. Aim: We investigated the efficiency of drug-eluting stents for coronary artery disease in patients on dialysis from the viewpoint of stent sizing. Methods: Sirolimus-eluting stents were implanted in 88 lesions and bare metal stents were implanted in 43 lesions. We compared stenting strategy, major adverse cardiac events, and angiographic results between sirolimus-eluting stent and bare metal stent groups. Results: Stent diameter was smaller and stent length was longer in the sirolimus-eluting stent group than in the bare metal stent group in our routine practices. There was no significant between-group difference in late diameter loss. Rates of angiographic restenosis and target lesion revascularization were significantly higher in the sirolimus-eluting stent group than in the bare metal stent group. Although stent length was significantly longer and stent diameter was smaller in the sirolimus-eluting stent group, sirolimus-eluting stents did not improve the subsequent clinical and angiographic results compared with bare metal stents in dialysis patients. Conclusion: In dialysis patients, a longer length and/or smaller diameter sirolimus-eluting stent implantation was associated with high rates of restenosis and target lesion revascularization compared with bare metal stents.

  18. Dedicated bifurcation stents

    Directory of Open Access Journals (Sweden)

    Ajith Ananthakrishna Pillai

    2012-03-01

    Full Text Available Bifurcation percutaneous coronary intervention (PCI is still a difficult call for the interventionist despite advancements in the instrumentation, technical skill and the imaging modalities. With major cardiac events relate to the side-branch (SB compromise, the concept and practice of dedicated bifurcation stents seems exciting. Several designs of such dedicated stents are currently undergoing trials. This novel concept and pristine technology offers new hope notwithstanding the fact that we need to go a long way in widespread acceptance and practice of these gadgets. Some of these designs even though looks enterprising, the mere complex delivering technique and the demanding knowledge of the exact coronary anatomy makes their routine use challenging.

  19. Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy.

    Science.gov (United States)

    Kereiakes, Dean J; Yeh, Robert W; Massaro, Joseph M; Driscoll-Shempp, Priscilla; Cutlip, Donald E; Steg, P Gabriel; Gershlick, Anthony H; Darius, Harald; Meredith, Ian T; Ormiston, John; Tanguay, Jean-François; Windecker, Stephan; Garratt, Kirk N; Kandzari, David E; Lee, David P; Simon, Daniel I; Iancu, Adrian Corneliu; Trebacz, Jaroslaw; Mauri, Laura

    2015-10-01

    This study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS. Despite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES. Prospective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months. Among 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference -1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference -1.8%, p = 0.053, noninferiority p stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  20. Intravascular stent graft with polyurethane and metallic stent: experimental study

    International Nuclear Information System (INIS)

    Do, Young Soo; Lee, Won Jae; Kim, Boo Kyung Han; Park, Jae Hyung; Lee, Hak Jong; Lee, Sang Hyun; Kim, Sung Hyun; Kim, Jong Won; Ha, Jongwon

    1997-01-01

    To evaluate the usefulness of a new model of the stent graft, and of tissue response related to placement of the stent graft. The stent graft was constructed from polyurethane (Pellethane) graft and Hanaro stent(12mm in diameter, 45mm in length, 10 bends). A stent grafts was inserted into the lower thoracic aorta in each of six adult mongrel dogs(body weight, 12-16kg). At one, two, four, and six months, follow-up studies of angiography and spiral CT angiography were preformed to evaluate wascular patency, vascular stenosis, and thrombus formation. Two dogs were sacrificed at 1month, 2months, and 6months after insertion of the stent graft and macroscopic, light microscopic, and scanning electron microscopic examinations of the aortic segment including the stent graft were performed to evaluate intimal hyperplasia, endothelial growth to the graft, and thrombus formation. During follow-up at one, two, four, and six months, angiography or spiral CT angiography showed 20-100% luminal stenosis or occlusion of the lower thoracic aorta by the thrombus and perigraft leaks in three dogs(50%), and collateral vessels caused by occlusion of the aorta in two (33.3%). On gross examination, there were thrombi of 1-5mm thickness at the graft portions in all dogs, and this thickness gradually increased. The mean thickness of intimal hyperplasia at the stent portion gradually increased from 120μm to 227μm and the mean thickness of intimal hyperplasia at the graft portion from 93μm to 914μm. This thickness was greater at the graft portion than at the stent portion. Scanning electron microscopy showed elliptical endothelial lining on the neointimal surfaces at each end of the graft. Thrombi caused stenosis or occlusion of the stent graft. In order for such a graft to be ideal, further study is needed

  1. Stent fabric fatigue of grafts supported by Z-stents versus ringed stents: an in vitro buckling test.

    Science.gov (United States)

    Lin, Jing; Wang, Lu; Guidoin, Robert; Nutley, Mark; Song, Ge; Zhang, Ze; Du, Jia; Douville, Yvan

    2014-03-01

    Stent-grafts externally fitted with a Z-shaped stents were compared to devices fitted with ringed stents in an in vitro oscillating fatigue machine at 200 cycles per minute and a pressure of 360 mmHg for scheduled durations of up to 1 week. The devices fitted with Z-stents showed a considerably lower endurance limit to buckling compared to the controls. The contact between the apexes of adjacent Z-stents resulted in significant damage to the textile scaffolds and polyester fibers due to the sharp angle of the Z-stents. The ringed stents did not cause any fraying in the textile scaffolds.

  2. Endoscopic Dilatation versus Oesophageal Stent in Benign Oesophageal Stricture

    Directory of Open Access Journals (Sweden)

    Hadyanto Caputra

    2016-09-01

    Full Text Available Aim: Oesophageal stricture is one of the causes of dysphagia. It is a condition in which the lumen of oesophagus is narrowed by fibrotic tissue in the oesophageal wall. It is usually caused by inflammation or any other cause that leads to necrotizing of tissue. It is mainly differentiated into benign or malignant. The aim of this article is to answer the clinical question on the effectiveness of oesophageal stenting compared to endoscopic dilatation in patient with benign oesophageal stricture due to ingestion of corrosive substances, who had undergone several endoscopic dilatations. Method: We conducted search of relevant articles using PubMed search engine to answer the clinical question. Keywords being used during the search process were: ("oesophageal stricture"[All Fields] OR "oesophageal stenosis"[All Fields] AND (("dilatation"[All Fields] AND ("stents"[MeSH Terms] OR "stents"[All Fields] OR "stent"[All Fields]. Results were further converged by adding specific filters, which were full text articles and clinical trial. Results: The chosen article was further appraised in order to identify its validity and eligibility to answer the clinical question. We chose to use CONSORT (statement to improve the quality of reporting of RCTs to facilitate the critical appraisal and interpretation of RCTs. Conclusion: Stenting was associated with greater dysphagia, co-medication and adverse events. No randomized controlled trials which compared biodegradable stents with other stents or with balloon dilatation was identified. Lack of adequately robust evidence for effectiveness and cost-effectiveness formed the rationale of this trial.

  3. Influence of stent design and use of protection devices on outcome of carotid artery stenting: a pooled analysis of individual patient data.

    Science.gov (United States)

    Wodarg, Fritz; Turner, Elisabeth L; Dobson, Joanna; Ringleb, Peter A; Mali, Willem P; Fraedrich, Gustav; Chatellier, Gilles; Bequemin, Jean-Pierre; Brown, Martin M; Algra, Ale; Mas, Jean-Louis; Jansen, Olav; Bonati, Leo H

    2018-04-19

    Carotid artery stenting is an alternative to endarterectomy for the treatment of symptomatic carotid stenosis but was associated with a higher risk of procedural stroke or death in randomized controlled trials (RCTs). Technical aspects of treatment may partly explain these results. The purpose of this analysis was to investigate the influence of technical aspects such as stent design or the use of protection devices, as well as clinical variables, on procedural risk. We pooled data of 1557 individual patients receiving stent treatment in three large RCTs comparing stenting versus endarterectomy for symptomatic carotid stenosis. The primary outcome event was any procedural stroke or death occurring within 30 days after stenting. Procedural stroke or death occurred significantly more often with the use of open-cell stents (61/595 patients, 10.3%) than with closed-cell stents (58/962 patients, 6.0%; RR 1.76; 95% CI 1.23 to 2.52; P=0.002). Procedural stroke or death occurred in 76/950 patients (8.0%) treated with protection devices (predominantly distal filters) and in 43/607 (7.1%) treated without protection devices (RR 1.10; 95% CI 0.71 to 1.70; P=0.67). Clinical variables predicting the primary outcome event were age, severity of the qualifying event, history of prior stroke, and level of disability at baseline. The effect of stent design remained similar after adjustment for these variables. In symptomatic carotid stenosis, the use of stents with a closed-cell design is independently associated with a lower risk of procedural stroke or death compared with open-cell stents. Filter-type protection devices do not appear to reduce procedural risk. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. Stent parameters predict major adverse clinical events and the response to platelet glycoprotein IIb/IIIa blockade: findings of the ESPRIT trial.

    Science.gov (United States)

    Tcheng, James E; Lim, Ing Haan; Srinivasan, Shankar; Jozic, Joseph; Gibson, C Michael; O'Shea, J Conor; Puma, Joseph A; Simon, Daniel I

    2009-02-01

    Only limited data describe relationships between stent parameters (length and diameter), adverse events after percutaneous coronary intervention, and effects of platelet glycoprotein IIb/IIIa blockade by stent parameters. In this post hoc analysis of the 1983 patients receiving a stent in the Enhanced Suppression of the Platelet Glycoprotein IIb/IIIa Receptor with Integrilin Therapy randomized percutaneous coronary intervention trial of eptifibatide versus placebo, rates of the major adverse cardiac event (MACE) end point (death, myocardial infarction, urgent target-vessel revascularization, or thrombotic bailout) at 48 hours and 1 year were correlated with stent parameters and then analyzed by randomization to eptifibatide versus placebo. In the placebo group, MACE increased with number of stents implanted, total stent length (by quartiles of or=30 mm), and total stented vessel area (by quartiles of area or=292 mm(2)). By stent parameters, MACE at 48 hours was reduced in the eptifibatide group at stent lengths of 18 to or=30 mm (OR, 0.43; 95% CI, 0.25 to 0.75; P=0.003), stent diameters of >2.5 to <3.5 mm (OR, 0.56; 95% CI, 0.39 to 0.82; P=0.002), and with 2 stents implanted (OR, 0.39; 95% CI, 0.22 to 0.69; P=0.001). In the placebo group, near-linear relationships were observed between both increasing stent length and increasing stented vessel area and MACE at 48 hours and 1 year (all, P<0.001); these gradients were flattened in the eptifibatide group (P=0.005 for stent length). Stent parameters predict MACE after percutaneous coronary intervention. Glycoprotein IIb/IIIa blockade mitigates much of the hazard of increasing procedural complexity.

  5. Percutaneous Intraductal Radiofrequency Ablation for Clearance of Occluded Metal Stent in Malignant Biliary Obstruction: Feasibility and Early Results

    Energy Technology Data Exchange (ETDEWEB)

    Pai, Madhava, E-mail: madhava.pai@imperial.ac.uk [Hammersmith Hospital, Imperial College, HPB Unit, Department of Surgery (United Kingdom); Valek, Vlastimil; Tomas, Andrasina [University Hospital Brno Bohunice, Department of Radiology (Czech Republic); Doros, Attila [Semmelweis University, Radiology Unit, Department of Transplantation and Surgery (Hungary); Quaretti, Pietro [IRCCS Policlinico San Matteo, Department of Radiology (Italy); Golfieri, Rita; Mosconi, Cristina [University of Bologna, Department of Radiology, Policlinico S. Orsola-Malpighi (Italy); Habib, Nagy, E-mail: nagy.habib@imperial.ac.uk [Hammersmith Hospital, Imperial College, HPB Unit, Department of Surgery (United Kingdom)

    2013-07-11

    PurposeThe major complication occurring with biliary stents is stent occlusion, frequently seen because of tumour in-growth, epithelial hyperplasia, and sludge deposits, resulting in recurrent jaundice and cholangitis. We report a prospective study with the results of first in man percutaneous intraductal radiofrequency (RF) ablation to clear the blocked metal stents in patients with malignant biliary obstruction using a novel bipolar RF catheter.MethodsNine patients with malignant biliary obstruction and blocked metal stents were included. These patients underwent intraductal biliary RF ablation through the blocked metal stent following external biliary decompression with an internal–external biliary drainage.ResultsAll nine patients had their stent patency restored successfully without the use of secondary stents. Following this intervention, there was no 30-day mortality, haemorrhage, bile duct perforation, bile leak, or pancreatitis. Of the nine patients, six are alive and three patients are dead with a median follow-up of 122 (range 50–488) days and a median stent patency of 102.5 (range 50–321) days. Six patients had their stent patent at the time of last follow-up or death. Three patients with stent blockage at 321, 290, and 65 days postprocedure underwent percutaneous transhepatic drain insertion and repeat ablation.ConclusionsIn this selective group of patients, it appears that this new approach is safe and feasible. Efficacy remains to be proven in future, randomized, prospective studies.

  6. Percutaneous Intraductal Radiofrequency Ablation for Clearance of Occluded Metal Stent in Malignant Biliary Obstruction: Feasibility and Early Results

    International Nuclear Information System (INIS)

    Pai, Madhava; Valek, Vlastimil; Tomas, Andrasina; Doros, Attila; Quaretti, Pietro; Golfieri, Rita; Mosconi, Cristina; Habib, Nagy

    2014-01-01

    PurposeThe major complication occurring with biliary stents is stent occlusion, frequently seen because of tumour in-growth, epithelial hyperplasia, and sludge deposits, resulting in recurrent jaundice and cholangitis. We report a prospective study with the results of first in man percutaneous intraductal radiofrequency (RF) ablation to clear the blocked metal stents in patients with malignant biliary obstruction using a novel bipolar RF catheter.MethodsNine patients with malignant biliary obstruction and blocked metal stents were included. These patients underwent intraductal biliary RF ablation through the blocked metal stent following external biliary decompression with an internal–external biliary drainage.ResultsAll nine patients had their stent patency restored successfully without the use of secondary stents. Following this intervention, there was no 30-day mortality, haemorrhage, bile duct perforation, bile leak, or pancreatitis. Of the nine patients, six are alive and three patients are dead with a median follow-up of 122 (range 50–488) days and a median stent patency of 102.5 (range 50–321) days. Six patients had their stent patent at the time of last follow-up or death. Three patients with stent blockage at 321, 290, and 65 days postprocedure underwent percutaneous transhepatic drain insertion and repeat ablation.ConclusionsIn this selective group of patients, it appears that this new approach is safe and feasible. Efficacy remains to be proven in future, randomized, prospective studies

  7. Initial study of sediment antagonism and characteristics of silver nanoparticle-coated biliary stents in an experimental animal model.

    Science.gov (United States)

    Tian, Yigeng; Xia, Mingfeng; Zhang, Shuai; Fu, Zhen; Wen, Qingbin; Liu, Feng; Xu, Zongzhen; Li, Tao; Tian, Hu

    2016-01-01

    Plastic biliary stents used to relieve obstructive jaundice are frequently blocked by sediment, resulting in loss of drainage. We prepared stents coated with silver nanoparticles (AgNPs) and compared their ability to resist sedimentation with Teflon stents in a beagle model of obstructive jaundice. AgNP-coated Teflon biliary stents were prepared by chemical oxidation-reduction and evaluated in an obstructive jaundice model that was produced by ligation of common bile duct (CBD); animals were randomized to two equal groups for placement of AgNP-coated or Teflon control stents. Liver function and inflammatory index were found to be similar in the two groups, and the obstruction was relieved. Stents were removed 21 days after insertion and observed by scanning and transmission electron microscopy. The AgNP coating was analyzed by energy dispersive X-ray analysis (EDXA), and the composition of sediment was assayed by Fourier-transform infrared (FTIR) spectroscopy. Electron microscopy revealed a black, closely adherent AgNP stent coating, with thicknesses of 1.5-6 µm. Sediment thickness and density were greater on Teflon than on AgNP-coated stents. EDXA confirmed the stability and integrity of the AgNP coating before and after in vivo animal experimentation. FTIR spectroscopy identified stent sediment components including bilirubin, cholesterol, bile acid, protein, calcium, and other substances. AgNP-coated biliary stents resisted sediment accumulation in this canine model of obstructive jaundice caused by ligation of the CBD.

  8. Percutaneous intraductal radiofrequency ablation for clearance of occluded metal stent in malignant biliary obstruction: feasibility and early results.

    Science.gov (United States)

    Pai, Madhava; Valek, Vlastimil; Tomas, Andrasina; Doros, Attila; Quaretti, Pietro; Golfieri, Rita; Mosconi, Cristina; Habib, Nagy

    2014-02-01

    The major complication occurring with biliary stents is stent occlusion, frequently seen because of tumour in-growth, epithelial hyperplasia, and sludge deposits, resulting in recurrent jaundice and cholangitis. We report a prospective study with the results of first in man percutaneous intraductal radiofrequency (RF) ablation to clear the blocked metal stents in patients with malignant biliary obstruction using a novel bipolar RF catheter. Nine patients with malignant biliary obstruction and blocked metal stents were included. These patients underwent intraductal biliary RF ablation through the blocked metal stent following external biliary decompression with an internal-external biliary drainage. All nine patients had their stent patency restored successfully without the use of secondary stents. Following this intervention, there was no 30-day mortality, haemorrhage, bile duct perforation, bile leak, or pancreatitis. Of the nine patients, six are alive and three patients are dead with a median follow-up of 122 (range 50-488) days and a median stent patency of 102.5 (range 50-321) days. Six patients had their stent patent at the time of last follow-up or death. Three patients with stent blockage at 321, 290, and 65 days postprocedure underwent percutaneous transhepatic drain insertion and repeat ablation. In this selective group of patients, it appears that this new approach is safe and feasible. Efficacy remains to be proven in future, randomized, prospective studies.

  9. Long Term Follow-up of a Transjugular Intrahepatic Portosystemic Shunt: A Comparison of Covered and Uncovered Stents

    Energy Technology Data Exchange (ETDEWEB)

    Joo, Seung Moon; Park, Jae Hyung; Kim, Hyo Cheol; Jae, Hwan Jun; Chung, Jin Wook [Seoul National University Hospital, Seoul (Korea, Republic of)

    2009-01-15

    To evaluate the long term patency of transjugular intrahepatic portosystemic shunts (TIPS) and to compare the patency rate of covered and uncovered stents in TIPS. The study population included 78 patients with portal hypertension that underwent TIPS between January 1999 and July 2007 at our institution using uncovered stents in 53 patients and covered stents in 25 patients. The primary and secondary patency rates of TIPS were estimated to compare the uncovered and covered stent groups. The primary and secondary patency rates of the TIPS patients were found to be 83.9% and 93.9% at the 6 month follow-up and 73.5% and 88.5% at the12 month follow-up for uncovered and covered stents, respectively. A breakdown patency rates for the 12 month follow-up revealed that the primary patency rates were 76.6% and 66.3% for uncovered and covered stents, respectively; whereas, the secondary patency rates were 94.3% and 73.8% for the uncovered and covered stents, respectively. A comparative analysis did not provide evidence to suggest that a difference exists between the patency rates of the uncovered and covered stent groups (p>0.05). No significant difference was found between the patency rates of the uncovered and covered stent groups. A follow-up to this study would be a more thorough randomized evaluation of the different types of covered stents to compare long-term patency rates.

  10. Temporary self-expanding cardia stents for the treatment of achalasia: an experimental study in dogs

    International Nuclear Information System (INIS)

    Zhu Yueqi; Cheng Yingsheng; Li Minghua; Zhao Jungong; Li Feng; Chen Niwei

    2011-01-01

    Objective: To assess the performance, efficiency and optimal removal time of a newly designed temporary retrievable cardia covered stent (TRC-CS) for the treatment of achalasia in a dog model. Methods: Eighty-four achalasia-like dog models were randomly divided into seven groups of 12, a control group (CG; no stent insertion), a standard stent control group (NSCG, standard esophageal stent) and five treatment groups (TG, TRC-CS). Stents were retrieved at 4 days after insertion in the NSCG and at 4 days (4 d-TG), 2 weeks (2 w-TG), 1 month (1 m-TG), 3 months (3 m-TG), and 6 months (6 m-TG) in the TGs. lower esophageal sphincter pressure (LESP) and a timed barium esophagram were assessed before stent insertion, after stent retrieval, and at 1-week, 1-, 3- and 6-month follow-up. Three dogs in NSCG and 4 d-TG were sacrificed for histological examination at each follow-up to investigate the inflammatory reaction after stent insertion. Results: Stent insertion/removal and the follow-up procedures were well tolerated. At 6-month follow-up, the 2 w-TG and 1 m-TG demonstrated an acceptable stent migration (n=2 in both TGs versus n=4 in NSCG, n=4 in 3 m-TG, and =6 in 6 m-TG), improved LESP compared to after BAC injection (P<0.05), and improved timed barium height (p=0.0144 and 0.0409). Mouse-proliferating cell nuclear antigen (PCNA) and α-smooth muscle actin staining revealed no inflammatory reaction difference between the NSCG and 4d-TG at each follow-up. Conclusion: The TRC-CS was effective in the treatment of achalasia in a dog model. LESP measurements, timed barium esophagram studies suggest an optimal stent retrieval time of between 2 w∼1 m. (authors)

  11. Percutaneous biliary drainage and stenting

    International Nuclear Information System (INIS)

    Totev, M.

    2012-01-01

    Full text: Percutaneous transhepatic cholangiography (PTC) is an X-ray or US guided procedure that involves the injection of a contrast material directly into the bile ducts inside the liver to produce pictures of them. If a blockage or narrowing is found, additional procedures may be performed: 1. insertion of a catheter to drain excess bile out of the body or both - internal and external; 2. plastic endoprothesis placement; 3. self-expandable metal stents placement to help open bile ducts or to bypass an obstruction and allow fluids to drain. Current percutaneous biliary interventions include percutaneous transhepatic cholangiography (PTC) and biliary drainage to manage benign and malignant obstructions. Internal biliary stents are either plastic or metallic, and various types of each kind are available. Internal biliary stents have several advantages. An external tube can be uncomfortable and have a psychological disadvantage. An internal stent prevents the problems related to external catheters, for example, pericatheter leakage of bile and the need for daily flushing. The disadvantages include having to perform endoscopic retrograde cholangiopancreatography (ERCP) or new PTC procedures to obtain access in case of stent obstruction. Better patency rates are reported with metallic than with plastic stents in cases of malignant obstruction, though no effect on survival is noted. Plastic internal stents are the cheapest but reportedly prone to migration. Metallic stents are generally not used in the treatment of benign disease because studies have shown poor long-term patency rates. Limited applications may include the treatment of patients who are poor surgical candidates or of those in whom surgical treatment fails. Most postoperative strictures are treated surgically, though endoscopic and (less commonly) percutaneous placement of nonmetallic stents has increasingly been used in the past few years. Now there are some reports about use of biodegradable biliary

  12. Impact of Tamsulosin, Tolterodine and drug-combination on the outcomes of lower urinary tract symptoms secondary to post-ureteroscopy ureteral stent: A prospective randomized controlled clinical study

    Directory of Open Access Journals (Sweden)

    O. Abdelkader

    2017-03-01

    Conclusion: Combination of alpha blockers (Tamsulosin and Anticholinergics (Tolterodine seems to significantly improve post-URS lower urinary tract symptoms secondary to ureteral stents with lower need for analgesia and better quality of life. Adverse effect of used drugs mentioned as transient and tolerated by the patients without need for auxiliary medication.

  13. Combined Arterial Infusion and Stent Implantation Compared with Metal Stent Alone in Treatment of Malignant Gastroduodenal Obstruction

    International Nuclear Information System (INIS)

    Wang Zhongmin; Chen Kemin; Gong Ju; Zheng Yunfeng; Wang Tianxiang

    2009-01-01

    .38 to 1.48 (p < 0.01). There were no short-term complications. Late complications including hematemesis (n = 3), migration (n = 12), and stent occlusion due to tumor overgrowth (n = 5) were evenly distributed between the groups. In the DIT group chemotherapy-induced neutropenia and transient renal dysfunction were detected in six patients, which improved after symptomatic management. Mean survival time after the procedure was 5.9 and 11.1 months for MSI and DIT, respectively (P < 0.001). In conclusion, both MSI and DIT offer effective palliation for malignant gastroduodenal obstruction, but DIT appears to offer superior survival over MSI alone. Ideally, a prospective randomized trial comparing these two techniques should be carried out to validate this result.

  14. Endotracheal expandable metallic stent placement in dogs

    Energy Technology Data Exchange (ETDEWEB)

    Sawada, S; Tanabe, Y; Fujiwara, Y; Koyama, T; Tanigawa, N; Kobayashi, M; Katsube, Y; Nakamura, H [Tottori Univ. School of Medicine, Yonago (Japan). Dept. of Radiology Research Inst. for Microbial Diseases, Osaka (Japan). Dept. of Radiology

    1991-01-01

    Various types of Gianturco zig-zag wire stent were implanted into the tracheas of 4 dogs to define the suitable characteristics of the endotracheal wire stent in these animals. These stents were constructed of 0.45, and 0.33 mm stainless steel wire. The diameter of the fully expanded stents was 3 cm and their lengths were 2, 3, and 4 cm. The 2 cm stent constructed of 0.33 mm wire showed minimum pathologic changes of the trachea of the dog compared to the other stents, and at the same time had a complete covering of ciliated columnar epithelium over the stent surface. (orig.).

  15. JJ Stent Removal under Ultrasound Guidance in Women: It is Simple and Safe.

    Science.gov (United States)

    Amer, Bernard; Gupta, Sandeep; Kanwar, Vijayendra S; Lodh, Bijit; Khumukcham, Somarendra; Akoijam, Kaku Singh

    2014-12-01

    With the increase in number of patients treated for urological problems with endoscopic procedures, the number of patients with JJ stent is also increasing. The amount of workload thus incurred multiplies, even to the point that, sometimes we waste more time in the operating room removing JJ stents than the actual endourological procedures. Here in our institute, we have devised a very simple and effective way of removing JJ stents in women and also determined the efficacy, safety and cost of JJ stent removal under ultrasound guidance in women in comparison to cystoscopic removal. Two hundred women attending the Department of Urology from July 2012 to July 2013 at RIMS hospital were randomly divided into two arms. One hundred women had their JJ stent removed with cystoscope and another 100 women had their JJ stent removed under ultrasound guidance using simple surgical tools available at the hospital. The primary comparative points were waiting time for operating room appointment date, cost of the procedure, time taken for the procedure, discomfort or pain felt by the patient and urethral injuries. In all the parameters, stent removal under ultrasound guidance was significantly better except for urethral injuries where both the procedures had similar outcomes. We concluded that JJ stent removal under ultrasound guidance in women was simple, effective and safe.

  16. Preliminary Report of Carotid Artery Stenting Using a Tapered Stent

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, Chang Woo; Kim, Dong Hyun; Hong, Seung; Jeong; Kim, Young Suk; Byun, Joo Nam; Oh, Jae Hee [Dept. of Radiology, Chosun University College of Medicine, Gwangju (Korea, Republic of); Ahn, Seong Hwan [Dept. of Neurology, Chosun University College of Medicine, Gwangju (Korea, Republic of)

    2011-10-15

    To analyze the results of carotid artery stenting using a tapered stent and to evaluate the effectiveness of the tapered stent compared to previously reported studies using non-tapered stents. From October 2008 to August 2010, elective carotid artery stenting using a tapered stent was attempted in 39 lesions from 36 consecutive patients. Post-procedural complications were evaluated by neurologic symptoms and magnetic resonance imaging. Restenosis or occlusion was evaluated by carotid Doppler ultrasound and computerized tomography with angiography. Newly developed neurologic symptoms were evaluated clinically. The self-expandable tapered stent was placed across the carotid artery stenosis. A total stroke was noted in 3 patients, while a major stroke was noted in 1 patient. On diffusion weighted imaging, new lesions were observed in 15 patients, but 13 patients were clinically silent. Follow-up imaging studies were performed in the 13 clinically silent lesions, and no evidence of restenosis or occlusion was found any of the 13 lesions. During clinical follow-up in 34 lesions from 31 patients, there were newly developed neurological symptoms in only 1 patient.

  17. Comparative analysis of intraluminal radiation stent in treatment of advanced esophageal carcinoma

    International Nuclear Information System (INIS)

    Guo Jinhe; Teng Gaojun; Zhu Guangyu; He Shicheng; Fang Wen; Deng Gang; Li Guozhao

    2007-01-01

    Objective: To compare the clinical effectiveness of intraluminal radiation stent with that of common covered stent to palliate dysphagia in advanced esophageal cancer. Methods: Fifty three cases were randomly assigned to the experimental group (Group A, n=27) and the control group (Group B, n26). Radiation stents were placed in Group A and common covered stents were placed in Group B. A randomized trial was performed to compare the two groups with respect to complications, relief of dysphagia, and overall survival period. Results: The placement of stents were successful in all the 53 patients. In Group A, no leakage of radiation source was observed through ECT examination, and no displacement of radiation seeds was found through radiography. The follow-up CT showed reduced lesion size compared to presurgical lesion. Three of the 5 patients who underwent uncovered radiation stent placement showed complete necrosis and inflammatory hyperblastosis in tumor tissue adjacent to radiation particles at 2 months follow-up. The lumen of the stents were smooth and had no overgrowth of tumor tissue. Granulation hyperplasia was found at both ends of the stents, prominent at the proximal ends, The incidence of stent- related complications had no significant difference between group A and group B (test, P>0.05). Dysphasia resolved significantly after stent placement in both groups. The improvement of dysphasia was more significant in Group A than in Group B after 2 months of stent placement (1.37±0.56 in group A, 1.82±0.50 in group B,P=0.004). The median survival period was longer in Group A than in Group B (7 months vs 4 months ). The mean survival period was also longer in Group A than in Group B (8.3 months vs 3.5 months). There was a statistically significant difference in the survival period between the two groups (P<0.01). Conclusion: Intraluminal radiation esophageal stent can not only palliate dysphagia but also restrain tumor growth. Palliation period of dysphagia and

  18. Radial force measurement of endovascular stents: Influence of stent design and diameter.

    Science.gov (United States)

    Matsumoto, Takuya; Matsubara, Yutaka; Aoyagi, Yukihiko; Matsuda, Daisuke; Okadome, Jun; Morisaki, Koichi; Inoue, Kentarou; Tanaka, Shinichi; Ohkusa, Tomoko; Maehara, Yoshihiko

    2016-04-01

    Angioplasty and endovascular stent placement is used in case to rescue the coverage of main branches to supply blood to brain from aortic arch in thoracic endovascular aortic repair. This study assessed mechanical properties, especially differences in radial force, of different endovascular and thoracic stents. We analyzed the radial force of three stent models (Epic, E-Luminexx and SMART) stents using radial force-tester method in single or overlapping conditions. We also analyzed radial force in three thoracic stents using Mylar film testing method: conformable Gore-TAG, Relay, and Valiant Thoracic Stent Graft. Overlapping SMART stents had greater radial force than overlapping Epic or Luminexx stents (P stents was greater than that of all three endovascular stents (P stents, site of deployment, and layer characteristics. In clinical settings, an understanding of the mechanical characteristics, including radial force, is important in choosing a stent for each patient. © The Author(s) 2015.

  19. The implantation of separating aortic stent-graft into the canine thoracic aorta: an experimental study

    International Nuclear Information System (INIS)

    Xia Jinguo; Shi Haibin; Yang Zhengqiang; Li Chao; Liu Sheng; Zu Qingquan; Li Linsun

    2011-01-01

    Objective: to assess the technical feasibility of implanting separating stent-graft into the canine thoracic aorta and to study its biocompatibility. Methods: Twelve adult dogs were randomly and equally divided into three groups. The right femoral artery was cut open, through which the separating stent-graft was inserted and deployed in the canine thoracic aorta, with the proximal end of the graft being quite close to the origin of the left subclavian artery. the technical feasibility of the deployment process was assessed. Angiography was performed at 4, 8 and 12 weeks after stent-graft placement to evaluate the position and patency of the stent-graft. Then the dogs were sacrificed and the specimens were collected for pathologic study. Both gross and microscopic examinations were made to evaluate the fixation of the stent-graft with the vessel wall, the endothelialization of stent-graft surface and the pathologic changes of the vascular wall. Results: A total of ten separating stent-grafts were successfully deployed in the canine thoracic aorta, no migration or deformation occurred. One dog died of massive bleeding due to the rupture of the right femoral artery which occurred when the delivery system containing the inner bare stent was inserted through the right femoral artery. Death occurred in another dog as a result of the ascending aorta rupture caused by the migration of outer-layer stent-graft. Angiography was conducted at 4, 8 and 12 weeks after stent-graft placement. No migration, deformation, rupture or stenosis of the implanted stent-grafts were observed. The formation of intima on the inner surface of the bare stent appeared at 4 weeks, which became more and more obvious with the time passing, and at 12 weeks complete endothelialization of stent-graft surface was observed. Conclusion: Technically, it is feasible to deploy the separating aortic stent-graft into the canine thoracic aorta. Moreover, the separating aortic stent-graft carries excellent

  20. Angiographic CT: in vitro comparison of different carotid artery stents-does stent orientation matter?

    Science.gov (United States)

    Lettau, Michael; Bendszus, Martin; Hähnel, Stefan

    2013-06-01

    Our aim was to evaluate the in vitro visualization of different carotid artery stents on angiographic CT (ACT). Of particular interest was the influence of stent orientation to the angiography system by measurement of artificial lumen narrowing (ALN) caused by the stent material within the stented vessel segment to determine whether ACT can be used to detect restenosis within the stent. ACT appearances of 17 carotid artery stents of different designs and sizes (4.0 to 11.0 mm) were investigated in vitro. Stents were placed in different orientations to the angiography system. Standard algorithm image reconstruction and stent-optimized algorithm image reconstruction was performed. For each stent, ALN was calculated. With standard algorithm image reconstruction, ALN ranged from 19.0 to 43.6 %. With stent-optimized algorithm image reconstruction, ALN was significantly lower and ranged from 8.2 to 18.7 %. Stent struts could be visualized in all stents. Differences in ALN between the different stent orientations to the angiography system were not significant. ACT evaluation of vessel patency after stent placement is possible but is impaired by ALN. Stent orientation of the stents to the angiography system did not significantly influence ALN. Stent-optimized algorithm image reconstruction decreases ALN but further research is required to define the visibility of in-stent stenosis depending on image reconstruction.

  1. Bile Duct Anastomosis Supplied With Biodegradable Stent in Liver Transplantation: The Initial Experience.

    Science.gov (United States)

    Janousek, L; Maly, S; Oliverius, M; Kocik, M; Kucera, M; Fronek, J

    2016-12-01

    The most common biliary complications after orthotopic liver transplantation are bile leaks, anastomotic and intrahepatic strictures, stones, and ampullary dysfunction. These complications can occur in up to 10% to 30% of liver transplant recipients. Leaks occur early in the posttransplant period; the stricture formation typically graduates over time. Ten patients underwent transplantation in our preliminary study: 5 were randomized to the group with stent placement and 5 to the control group. We investigated the role of an absorbable biliary stent with the goal of proving patency of duct-to-duct biliary anastomosis. The stents are made of machine-knitted polydioxanone monofilaments. Our initial results show that duct-to-duct biliary reconstruction using an absorbable internal stent had good patency in all 5 patients. There were no signs of biliary leakage accompanying the anastomoses in any of the cases, and there was no stone formation observed after liver transplantation. The biliary stent was completely absorbed, with no adverse effects. Based on our initial experience and data, we concluded that biodegradable stents can be successfully and safely used in clinical practice. Further large prospective randomized studies are needed to estimate the efficacy of the bioabsorbable stents. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Acceptance and introduction of disruptive technologies - simple steps to build a fully functional pulmonary valved stent.

    Science.gov (United States)

    Huber, Christoph H; Marty, Bettina; von Segesser, Ludwig K

    2007-08-01

    Valved stents are new land for cardiac surgeons even though they are being used more frequently by interventional disciplines. This paper presents simple steps to build a patient-specific pulmonary valved stent and its delivery device. The design concept was tested by random participants at a med-tech meeting. The valved stent is constructed by linking an endoprosthetic graft with a valved-jugular-vein. The delivery device is made from a modified 5-ml syringe. Of 72 participants, 66 (92%) built and 60 participants implanted the device successfully into the targeted pulmonary position via a trans-infundibular access.

  3. [Coronary stents: 30 years of medical progress].

    Science.gov (United States)

    Silvain, Johanne; Cayla, Guillaume; Collet, Jean-Philippe; Fargeot, Catherine; Montalescot, Gilles

    2014-03-01

    The history of interventional cardiology has been marked by several technologic revolutions since the late 1970s. The first key step was the use of inflatable balloon angioplasty as an alternative to CABG surgery for coronary revascularization, followed by intracoronary delivery of bare metal stent (BMS) and drug eluting stents (DES) to drastically reduce intracoronary restenosis observed with BMS. Improved stents platforms and polymers (absorbable or biocompatible) led to a dramatic reduction in the rate of late stent thrombosis. Self-expanding stents are now available to improve stent a position especially in acute myocardial infarction. The emergence of new fully bioabsorbable stents that can be combined with antiproliferative drugs is the ongoing revolution. A new generation of stents is continuously improving and likely to become the ideal stent for coronary revascularization in the near future. © 2014 médecine/sciences – Inserm.

  4. Drug-eluting stent thrombosis: results from the multicenter Spanish registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos).

    Science.gov (United States)

    de la Torre-Hernández, José M; Alfonso, Fernando; Hernández, Felipe; Elizaga, Jaime; Sanmartin, Marcelo; Pinar, Eduardo; Lozano, Iñigo; Vazquez, Jose M; Botas, Javier; Perez de Prado, Armando; Hernández, Jose M; Sanchis, Juan; Nodar, Juan M Ruiz; Gomez-Jaume, Alfredo; Larman, Mariano; Diarte, Jose A; Rodríguez-Collado, Javier; Rumoroso, Jose R; Lopez-Minguez, Jose R; Mauri, Josepa

    2008-03-11

    This study sought to assess the incidence, predictors, and outcome of drug-eluting stent(DES) thrombosis in real-world clinical practice. The DES thromboses in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. We designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring. Of 23,500 patients treated with DES, definite stent thrombosis(ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred >1 year(very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases(31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction <45%, nonrestoration of Thrombolysis In Myocardial Infarction flow grade 3, and additional stenting were independent predictors for mortality. The cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.

  5. TIDES-ACS Trial: comparison of titanium-nitride-oxide coated bio-active-stent to the drug (everolimus)-eluting stent in acute coronary syndrome. Study design and objectives.

    Science.gov (United States)

    Colkesen, E B; Eefting, F D; Rensing, B J; Suttorp, M J; Ten Berg, J M; Karjalainen, P P; Van Der Heyden, J A

    2015-02-01

    Drug-eluting stents (DES), delivering antiproliferative drugs from a durable polymer, have shown to reduce in-stent restenosis after percutaneous coronary intervention (PCI) compared to bare-metal stents (BMS). However, they have been associated with a hypersensitivity reaction, delayed healing, and incomplete endothelialization, which may contribute to an increased risk of late stent thrombosis. Consequently, a prolonged duration of dual antiplatelet therapy (DAPT) is needed, with an increased risk of bleeding complication. A number of stent technologies are being developed in an attempt to modify late thrombotic events and DAPT duration. The Optimax™ stent is such a novel, next generation bioactive stent (BAS), in which a thicker layer of titanium-nitride-oxide coating is inserted over the stent struts. The rationale of this is to obtain more efficient and rapid vascular healing at the site of the stent implantation. The aim of TIDES-ACS Trial is to compare clinical outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus Synergy™-EES. Second objective is to explore whether the Optimax™-BAS use is superior compared with Synergy™-EES use with respect of hard end points (cardiac death, myocardial infarction [MI] and major bleeding). A prospective, randomized, multicenter trial (ClinicalTrials.gov Identifier: NCT02049229), will be conducted in interventional centres in Finland (six centres), France (five centres) and Holland (two centres), including a total of 1800 patients.

  6. Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease

    DEFF Research Database (Denmark)

    Raungaard, Bent; Christiansen, Evald H; Bøtker, Hans Erik

    2017-01-01

    artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion......OBJECTIVES: The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients. BACKGROUND: Biodegradable-polymer biolimus-eluting stents are superior to first......-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking. METHODS: The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary...

  7. Stenting of major airway constriction

    International Nuclear Information System (INIS)

    Wu Xiaomei

    2002-01-01

    Objective: To investigate the correlated issues in the stenting treatment of major airway constriction. Methods: Nineteen cases of major airway stenting procedure were studied retrospectively. The clinical choice of stents of different advantages or deficiencies were discussed. The importance of intravenous anesthesia supporting, life-parameters monitoring during the procedures and the prevention of complications were analysed. Results: Under intravenous and local anesthesia, 19 Wallstents had been successively placed and relieved 19 cases of major airway constrictions due to malignant or benign diseases (15 of tumors, 3 of tuberculosis, 1 of tracheomalacia). Intravenous anesthesia and life-parameters monitoring had made the procedures more safe and precise. Conclusions: Major airway stenting is an reliable method for relieving tracheobronchial stenosis; and intravenous anesthesia supporting and life-parameters monitoring guarantee the satisfactions of procedures

  8. Feasibility study using a Ni-Ti stent and electronic portal imaging to localize the prostate during radiotherapy.

    Science.gov (United States)

    Carl, Jesper; Lund, Bente; Larsen, Erik Hoejkjaer; Nielsen, Jane

    2006-02-01

    A new method for localization of the prostate during external beam radiotherapy is presented. The method is based on insertion of a thermo-expandable Ni-Ti stent. The stent is originally developed for treatment of bladder outlet obstruction caused by benign hyperplasia. The radiological properties of the stent are used for precise prostate localization during treatment using electronic portal images. Patients referred for intended curative radiotherapy and having a length of their prostatic urethra in the range from 25 to 65 mm were included. Pairs of isocentric orthogonal portal images were used to determine the 3D position at eight different treatment sessions for each patient. Fourteen patients were enrolled in the study. The data obtained demonstrated that the stent position was representative of the prostate location. The stent may also improve delineation of the prostate GTV, and prevent obstruction of bladder outlet during treatment. Precision in localization of the stent was less than 1 mm. Random errors in stent position were left-right 1.6 mm, cranial-caudal 2.2 mm and anterior-posterior 3.2 mm. In four of 14 patients a dislocation of the stent to the bladder occurred. Dislocation only occurred in patients with length of prostatic urethra less than 40 mm. A new method for radiological high precision localization of the prostate during radiotherapy is presented. The method is based on insertion of a standard Ni-Ti thermo-expandable stent, designed for treatment of benign prostate hyperplasia.

  9. Supera self-expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence

    Directory of Open Access Journals (Sweden)

    Bishu K

    2015-07-01

    Full Text Available Kalkidan Bishu,1,2 Ehrin J Armstrong1,21Division of Cardiology, University of Colorado, Aurora, 2Denver VA Medical Center, Denver, CO, USAAbstract: Femoropopliteal lesions account for a significant proportion of endovascular interventions for peripheral artery disease in patients with disabling claudication or chronic limb ischemia. The femoropopliteal artery crosses two joint structures (hip and knee joints and courses through the muscular adductor canal in the thigh, which places the artery at increased biomechanical stress. There is a critical need for stent platforms with a reduced risk of stent fracture while maintaining patency during long-term follow-up. The Supera peripheral stent system has a braided nickel–titanium alloy stent designed to withstand the unique stressors along the course of the femoropopliteal artery. This design may be associated with improved patency in association with reduced stent fracture rates on short- and medium-term follow-up. Further studies, including randomized controlled studies, comparing the Supera interwoven nickel–titanium alloy stent system with other stent platforms and angioplasty alone are needed.Keywords: peripheral artery disease, femoropopliteal atherosclerosis, SUPERA interwoven nitinol stent, stent fracture

  10. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial

    DEFF Research Database (Denmark)

    Kaltoft, Anne; Kelbaek, Henning; Thuesen, Leif

    2010-01-01

    The purpose of this study was to compare long-term clinical outcomes after implantation of drug-eluting stents (DES) and bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI).......The purpose of this study was to compare long-term clinical outcomes after implantation of drug-eluting stents (DES) and bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI)....

  11. Carotid angioplasty and stenting in the elderly

    International Nuclear Information System (INIS)

    Kadkhodayan, Yasha; Cross, DeWitte T.; Moran, Christopher J.; Derdeyn, Colin P.

    2007-01-01

    To investigate the technical success rate as well as the procedural and mid-term complication rates of carotid angioplasty and stenting in elderly patients, a group excluded from large randomized endarterectomy trials given their perceived high surgical risk. Of 200 consecutive carotid angioplasty and/or stenting procedures performed between March 1996 and March 2005, 21 procedures were performed without cerebral protection devices in 20 patients over the age of 79 years (mean age: 83 years, 12 men, eight women). These patients' medical records were retrospectively reviewed for vascular imaging reports and available clinical follow-up. Procedural and mid-term complication rates were calculated and compared to a previously published cohort of 133 consecutive patients ≤79 years of age who also underwent endovascular treatment at our institution. Carotid stenosis was reduced from a mean of 82% to no significant stenosis in all procedures. The procedural stroke rate was zero of 21 procedures. The procedural transient ischemic attack rate (TIA) was one of 21 procedures (4.8%). Mean follow-up was 24.6 months (range: 1.0-79.5 months) with at least a 30-day follow-up for 20 of the 21 procedures (95.2%). There were no new strokes. There was one recurrent ipsilateral TIA at 1.9 months. In five cases with follow-up carotid ultrasonography, no hemodynamically significant restenosis had occurred. There were three myocardial infarctions (MI) occurring at 0.5, 2.1, and 15.2 months, of which the last MI was fatal. The composite 30-day stroke and death rate was zero of 21 procedures (95% confidence interval: 0-14%). No significant difference was found in the 30-day rate of stroke, TIA, MI, or death between the elderly and younger patients. Carotid angioplasty and stenting in elderly patients can be performed successfully with acceptable procedural and mid-term complication rates comparable to younger patients. (orig.)

  12. Self-Expanding Nitinol Renal Artery Stents: Comparison of Safety and Efficacy of Bare Versus Polyzene-F Nanocoated Stents in a Porcine Model

    International Nuclear Information System (INIS)

    Kurz, P.; Stampfl, U.; Christoph, P.; Henn, C.; Satzl, S.; Radeleff, B.; Berger, I.; Richter, G. M.

    2011-01-01

    Objective: To investigate the safety and efficacy of a Polyzene-F nanocoat on new low-profile self-expandable nitinol stents in minipig renal arteries. Materials and Methods: Ten bare nitinol stents (BNS) and 10 stents coated with a 50 nm-thin Polyzene-F coating were randomly implanted into renal arteries of 10 minipigs (4- and 12-week follow-up, 5 animals/group). Thrombogenicity, on-stent surface endothelialization, vessel wall injury, late in-stent stenosis, and peristrut vessel wall inflammation were determined by quantitative angiography and postmortem histomorphometry. Results: In 6 of 10 BNS, >50% stenosis was found, but no stenosis was found in stents with a nanothin Polyzene-F coating. Histomorphometry showed a statistically significant (p < 0.05) different average maximum luminal loss of 55.16% ± 8.43% at 12 weeks in BNS versus 39.77% ± 7.41% in stents with a nanothin Polyzene-F coating. Stents with a nanothin Polyzene-F coating had a significantly (p < 0.05) lower inflammation score after 12 weeks, 1.31 ± 1.17 versus 2.17 ± 0.85 in BNS. The results for vessel wall injury (0.6 ± 0.58 for Polyzene-F-coated stents; 0.72 ± 0.98 for BNS) and re-endothelialization, (1.16 ± 0.43 and 1.23 ± 0.54, respectively) were not statistically significant at 12-week follow-up. No thrombus deposition was observed on the stents at either follow-up time point. Conclusion: Nitinol stents with a nanothin Polyzene-F coating successfully decreased in-stent stenosis and vessel wall inflammation compared with BNS. Endothelialization and vessel wall injury were found to be equal. These studies warrant long-term pig studies (≥120 days) because 12 weeks may not be sufficient time for complete healing; thereafter, human studies may be warranted.

  13. Stent migration after right ventricular outflow tract stenting in the severe cyanotic Tetralogy of Fallot case

    Directory of Open Access Journals (Sweden)

    Tamaki Hayashi

    2017-01-01

    Full Text Available We report our experience with a stent migration after right ventricle outflow tract stenting and converted to patent ductus arteriosus stenting in Tetralogy of Fallot (TOF with severe infundibular stenosis. Finally, the patient achieved to TOF repair, and the migrated stent was removed without any complication.

  14. Mechanisms of Biliary Plastic Stent Occlusion and Efforts at Prevention

    Directory of Open Access Journals (Sweden)

    Chang-Il Kwon

    2016-03-01

    Full Text Available Biliary stenting via endoscopic retrograde cholangiopancreatography has greatly improved the quality of patient care over the last 30 years. Plastic stent occlusion limits the life span of such stents. Attempts to improve plastic stent patency duration have mostly failed. Metal stents (self-expandable metal stents [SEMSs] have therefore replaced plastic stents, especially for malignant biliary strictures. SEMS are at least 10 times more expensive than plastic stents. In this focused review, we will discuss basic mechanisms of plastic stent occlusion, along with a systematic summary of previous efforts and related studies to improve stent patency and potential new techniques to overcome existing limitations.

  15. Angioplasty and stent placement - carotid artery - discharge

    Science.gov (United States)

    ... medlineplus.gov/ency/patientinstructions/000235.htm Angioplasty and stent placement - carotid artery - discharge To use the sharing ... the hospital. You may have also had a stent (a tiny wire mesh tube) placed in the ...

  16. Angioplasty and stent placement - peripheral arteries - discharge

    Science.gov (United States)

    ... medlineplus.gov/ency/patientinstructions/000234.htm Angioplasty and stent placement - peripheral arteries - discharge To use the sharing ... peripheral artery). You may have also had a stent placed. To perform the procedure: Your doctor inserted ...

  17. Angioplasty and stent placement - peripheral arteries

    Science.gov (United States)

    ... medlineplus.gov/ency/article/007393.htm Angioplasty and stent placement - peripheral arteries To use the sharing features ... inside the arteries and block blood flow. A stent is a small, metal mesh tube that keeps ...

  18. Short-term safety and efficacy of the biodegradable iron stent in mini-swine coronary arteries

    Institute of Scientific and Technical Information of China (English)

    WU Chao; QIU Hong; HU Xiao-ying; RUAN Ying-mao; TIAN Yi; CHU Yan; XU Xin-lin

    2013-01-01

    Background To overcome the drawbacks of permanent stents,biodegradable stents have been studied in recent years.The bioabsorbable polymer vascular scaffold (BVS) was the first bioabsorbable stent to undergo clinical trials,demonstrating safety and feasibility in the ABSORB studies.Iron can potentially serve as the biomaterial for biodegradable stents.This study aimed to assess the short-term safety and efficacy of a biodegradable iron stent in mini-swine coronary arteries.Methods Eight iron stents and eight cobalt chromium alloy (VISION) control stents were randomly implanted into the LAD and RCA of eight healthy mini-swine,respectively.Two stents of the same metal base were implanted into one animal.At 28 days the animals were sacrificed after coronary angiography,and histopathological examinations were performed.Results Histomorphometric measurements showed that mean neointimal thickness ((0.46±0.17) mm vs.(0.45±0.18)mm,P=0.878),neointimal area ((2.55±0.91) mm2 vs.(3.04±1.15) mm2,P=0.360) and percentage of area stenosis ((44.50±11.40)% vs.(46.00±17.95)%,P=0.845) were not significantly different between the iron stents and VISION stents.There was no inflammation,thrombosis or necrosis in either group.The scanning electron microscopy (SEM) intimal injury scores (0.75±1.04 vs.0.88±0.99,P=0.809) and number of proliferating cell nuclear antigen (PCNA) positive staining cells were not significantly different between the two groups.The percentage of neointimal coverage by SEM examination was numerically higher in iron stents than in VISION stents ((84.38±14.50)% vs.(65.00±22.04)%,P=0.057),but the difference was not statistically significant.Iron staining in the tissue surrounding the iron stents at 28 days was positive and the vascular wall adjacent to the iron stent had a brownish tinge,consistent with iron degradation.No abnormal histopathological changes were detected in coronary arteries or major organs.Conclusions The biodegradable iron stent has

  19. Management of stent dislodgment in coarctoplasty of aorta with three overlapping self-expandable nitinol stents.

    Science.gov (United States)

    Ghazi, Payam; Haji-Zeinali, Ali-Mohammad

    2010-01-01

    We describe a case of native coarctation of aorta managed with three self-expandable nitinol stents. After balloon pre-dilation, the first and second stents were dislodged. The coarcted area was successfully treated with the third stent overlapped with the previous stents. During follow up (30 months), the patient was free of complications. It seems that implantation of multiple overlapping self-expandable stents in aortic coarctation patients, if needed, is safe and possible.

  20. Optical Coherence Tomography Substudy of A Prospective Multicenter Randomized Post-Market Trial to Assess the Safety and Effectiveness of the Firehawk™ Rapamycin Target Eluting Cobalt Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesions: TARGET All Comers.

    Science.gov (United States)

    Baumbach, Andreas; Lansky, Alexandra J; Onuma, Yoshi; Asano, Taku; Johnson, Thomas; Anderson, Richard; Kiemeneij, Ferdinand; Zheng, Ming; Van Royen, Niels; Slagboom, Ton; Vlachojannis, Georg; Xu, Bo; Serruys, Patrick; Wijns, William

    2018-06-12

    Durable polymer drug-eluting stents (DP DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this Optical Coherence Tomography (OCT) sub-study was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (FIREHAWK®) (BP DES) versus the DP DES (XIENCE) at 90 days in an all comers patient population. The TARGET All Comers study is a prospective multicenter randomised post-market trial of 1656 patients randomised 1:1 to FIREHAWK or XIENCE at 21 centers in 10 European countries. The TARGET OCT sub-study enrolled 36 consecutive patients with 52 lesions at 6 centers proficient in OCT. Follow-up OCT was performed at 3 months or prior to revascularisation when occurring before the 3-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions, Firehawk, n=24; Xience, n=28), was not significantly different between groups (Firehawk 75.5μm vs Xience V 82.3 μm) meeting the primary endpoint of non-inferiority (Pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9% ± 0.3 vs 100% ± 0.1, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups. Based on OCT, the FIREHAWK BP DES has a similar healing response 3 months after implantation compared to the DP DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

  1. Long term outcomes of new generation drug eluting stents versus coronary artery bypass grafting for multivessel and/or left main coronary artery disease. A Bayesian network meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Mina, George S; Watti, Hussam; Soliman, Demiana; Shewale, Anand; Atkins, Jessica; Reddy, Pratap; Dominic, Paari

    2018-01-05

    Most data guiding revascularization of multivessel disease (MVD) and/or left main disease (LMD) favor coronary artery bypass grafting (CABG) over percutaneous coronary intervention (PCI). However, those data are based on trials comparing CABG to bare metal stents (BMS) or old generation drug eluting stents (OG-DES). Hence, it is essential to outcomes of CABG to those of new generation drug eluting stents (NG-DES). We searched PUBMED and Cochrane database for trials evaluating revascularization of MVD and/or LMD with CABG and/or PCI. A Bayesian network meta-analysis was performed to calculate odds ratios (OR) and 95% credible intervals (CrI). Primary outcome was major adverse cardiovascular events (MACE) at 3-5 years. Secondary outcomes were mortality, cerebrovascular accidents (CVA), myocardial infarction (MI) and repeat revascularization. We included 10 trials with a total of 9287 patients. CABG was associated with lower MACE when compared to BMS or OG-DES. However, MACE was not significantly different between CABG and NG-DES (OR 0.79, CrI 0.45-1.40). Moreover, there were no significant differences between CABG and NG-DES in mortality (OR 0.78, CrI 0.45-1.37), CVA (OR 0.93 CrI 0.35-2.2) or MI (OR 0.6, CrI 0.17-2.0). On the other hand, CABG was associated with lower repeat revascularization (OR 0.55, CrI 0.36-0.84). Our study suggests that NG-DES is an acceptable alternative to CABG in patients with MVD and/or LMD. However, repeat revascularization remains to be lower with CABG than with PCI. Copyright © 2018. Published by Elsevier Inc.

  2. Plastic biliary stents for malignant biliary diseases

    NARCIS (Netherlands)

    Huibregtse, Inge; Fockens, Paul

    2011-01-01

    Plastic biliary endoprostheses have not changed much since their introduction more than 3 decades ago. Although their use has been challenged by the introduction of metal stents, plastic stents still remain commonly used. Much work has been done to improve the problem of stent obstruction but

  3. Therapies targeting inflammation after stent implantation.

    Science.gov (United States)

    Okura, Hiroyuki; Takagi, Tsutomu; Yoshida, Kiyoshi

    2013-07-01

    Since the introduction of coronary vessel scaffold by metallic stent, percutaneous coronary intervention has become widely performed all over the world. Although drug-eluting stent technology has further decrease the incidence of in-stent restenosis, there still remaining issues related to stent implantation. Vessel inflammation is one of the causes that may be related to stent restenosis as well as stent thrombosis. Therefore, systemic therapies targeting inflammation emerged as adjunctive pharmacological intervention to improve outcome. Statins, corticosteroids, antiplatelets, and immunosuppresive or anti-cancer drugs are reported to favorably impact outcome after bare-metal stent implantation. In type 2 diabetic patients, pioglitazone may be the most promising drug that can lower neointimal proliferation and, as a result, lower incidence of restenosis and target lesion revascularization. On the other hand, several new stent platforms that might decrease inflammatory response after drug-eluting stent implantation have been introduced. Because durable polymer used in the first generation drug-eluting stents are recognized to be responsible for unfavorable vessel response, biocompatible or bioabsorbable polymer has been introduce and already used clinically. Furthermore, polymer-free drug-eluting stent and bioresorbable scaffold are under investigation. Although vessel inflammation may be reduced by using these new drug-eluting stents or scaffold, long-term impact needs to be investigated further.

  4. Incidence and predictors of coronary stent thrombosis

    DEFF Research Database (Denmark)

    D'Ascenzo, Fabrizio; Bollati, Mario; Clementi, Fabrizio

    2013-01-01

    Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent...

  5. 21 CFR 876.4620 - Ureteral stent.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ureteral stent. 876.4620 Section 876.4620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Surgical Devices § 876.4620 Ureteral stent. (a) Identification. A ureteral stent...

  6. 21 CFR 884.3900 - Vaginal stent.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vaginal stent. 884.3900 Section 884.3900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to...

  7. Metallic ureteral stents in malignant ureteral obstruction: clinical factors predicting stent failure.

    Science.gov (United States)

    Chow, Po-Ming; Hsu, Jui-Shan; Huang, Chao-Yuan; Wang, Shuo-Meng; Lee, Yuan-Ju; Huang, Kuo-How; Yu, Hong-Jheng; Pu, Yeong-Shiau; Liang, Po-Chin

    2014-06-01

    To provide clinical outcomes of the Resonance metallic ureteral stent in patients with malignant ureteral obstruction, as well as clinical factors predicting stent failure. Cancer patients who have received Resonance stents from July 2009 to March 2012 for ureteral obstruction were included for chart review. Stent failure was detected by clinical symptoms, image studies, and renal function tests. Survival analysis for stent duration was used to estimate patency rate and factors predicting stent failure. A total of 117 stents were inserted successfully into 94 ureteral units in 79 patients. There were no major complications. These stents underwent survival analysis and proportional hazard regression. The median duration for the stents was 5.77 months. In multivariate analysis, age (P=0.043), preoperative serum creatinine level (P=0.0174), and cancer type (P=0.0494) were significant factors associated with stent failure. Cancer treatment before and after stent insertion had no effect on stent duration. Resonance stents are effective and safe in relieving malignant ureteral obstructions. Old age and high serum creatinine level are predictors for stent failure. Stents in patients with lower gastrointestinal cancers have longer functional duration.

  8. Micro-invasive glaucoma surgery (MIGS: a review of surgical procedures using stents

    Directory of Open Access Journals (Sweden)

    Pillunat LE

    2017-08-01

    Full Text Available Lutz E Pillunat,1 Carl Erb,2 Anselm GM Jünemann,3 Friedemann Kimmich4 1Department of Ophthalmology, University Hospital Carl Gustav Carus, Dresden, 2Augenklinik am Wittenbergplatz, Berlin, Germany; 3Department of Ophthalmology University of Rostock, Rostock, Germany; 4eyecons, Karlsruhe, Germany Abstract: Over the last decade several novel surgical treatment options and devices for glaucoma have been developed. All these developments aim to cause as little trauma as possible to the eye, to safely, effectively, and sustainably reduce intraocular pressure (IOP, to produce reproducible results, and to be easy to adopt. The term “micro-invasive glaucoma surgery (MIGS” was used for summarizing all these procedures. Currently MIGS is gaining more and more interest and popularity. The possible reduction of the number of glaucoma medications, the ab interno approach without damaging the conjunctival tissue, and the probably safer procedures compared to incisional surgical methods may explain the increased interest in MIGS. The use of glaucoma drainage implants for lowering IOP in difficult-to-treat patients has been established for a long time, however, a variety of new glaucoma micro-stents are being manufactured by using various materials and are available to increase aqueous outflow via different pathways. This review summarizes published results of randomized clinical studies and extensive case report series on these devices, including Schlemm’s canal stents (iStent®, iStent® inject, Hydrus, suprachoroidal stents (CyPass®, iStent® Supra, and subconjunctival stents (XEN. The article summarizes the findings of published material on efficacy and safety for each of these approaches. Keywords: glaucoma, micro-invasive glaucoma surgery, MIGS, iStent, iStent inject, CyPass, Hydrus, XEN

  9. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Christiansen, Evald Høj

    2016-01-01

    BACKGROUND: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. OBJECTIVES: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical...... rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR...... in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877)....

  10. Coronary and peripheral stenting in aorto-ostial protruding stents: The balloon assisted access to protruding stent technique.

    Science.gov (United States)

    Helmy, Tarek A; Sanchez, Carlos E; Bailey, Steven R

    2016-03-01

    Treatment of aorto-ostial in-stent restenosis lesions represents a challenge for interventional cardiologists. Excessive protrusion of the stent into the aorta may lead to multiple technical problems, such as difficult catheter reengagement of the vessel ostium or inability to re-wire through the stent lumen in repeat interventions. We describe a balloon assisted access to protruding stent technique in cases where conventional coaxial engagement of an aorto-ostial protruding stent with the guide catheter or passage of the guide wire through the true lumen is not feasible. This technique is applicable both in coronary and peripheral arteries. © 2015 Wiley Periodicals, Inc.

  11. Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study)

    DEFF Research Database (Denmark)

    Maeng, Michael; Tilsted, Hans Henrik; Jensen, Lisette Okkels

    2014-01-01

    received two different types of drug-eluting stents. METHODS: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug......-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone...

  12. A comparative study of short- and medium-term outcomes comparing emergent surgery and stenting as a bridge to surgery in patients with acute malignant colonic obstruction.

    LENUS (Irish Health Repository)

    Kavanagh, Dara O

    2013-04-01

    The use of self-expanding metal stents as a bridge to surgery in the setting of malignant colorectal obstruction has been advocated as an acceptable alternative to emergency surgery. However, concerns about the safety of stenting have been raised following recent randomized studies.

  13. Off-pump coronary artery bypass grafting or percutaneous transluminal coronary angioplasty with stenting for proximal left anterior descending coronary artery disease?

    NARCIS (Netherlands)

    Drenth, Derk Jan

    2005-01-01

    This thesis describes and discusses the results of a prospective randomized controlled clinical trial comparing percutaneous coronary angioplasty with stenting (stenting) and off-pump coronary artery bypass grafting with a left internal mammary artery (surgery) in patients with a high-grade stenosis

  14. Experimental absorbable stent permits airway remodeling.

    Science.gov (United States)

    Liu, Kuo-Sheng; Liu, Yun-Hen; Peng, Yi-Jie; Liu, Shih-Jung

    2011-02-01

    Despite metallic and silicone stents being effective in treating various airway lesions, many concerns still remain. A bioresorbable stent that scaffolds the airway lumen and dissolves after the remodeling process is completed has advantages over metallic and silicone stents. We designed and fabricated a new mesh-type bioresorbable stent with a backbone of polycaprolactone (PCL), and evaluated its safety and biocompatibility in a rabbit trachea model. The PCL stent was fabricated by a laboratory-made microinjection molding machine. In vitro mechanical strength of the PCL stents was tested and compared to that of commercial silicone stents. The bioresorbable stents were surgically implanted into the cervical trachea of New Zealand white rabbits (n=6). Animals received bronchoscopic examination at 1, 2, 4, 8, and 12 weeks after surgery. Histological examination was completed to evaluate the biocompatibility of the stents. No animals died during the period of study. Distal stent migration was noted in 1 rabbit. In-stent secretion accumulation was found in 2 rabbits. Histological examination showed intact ciliated epithelium and marked leukocyte infiltration in the submucosa of the stented area at 10 and 28 weeks. Stent degradation was minimal, and the mechanical strength was well preserved at the end of 33 weeks. These preliminary findings showed good safety and biocompatibility of the new PCL stent when used in the airway remodeling. PCL could be a promising bioresorbable material for stent design if prolonged degradation time is required. Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  15. Microvascular stent anastomosis using N-fibroin stents: feasibility, ischemia time, and complications.

    Science.gov (United States)

    Smeets, Ralf; Vorwig, Oliver; Wöltje, Michael; Gaudin, Robert; Luebke, Andreas M; Beck-Broichsitter, Benedicta; Rheinnecker, Michael; Heiland, Max; Grupp, Katharina; Gröbe, Alexander; Hanken, Henning

    2016-05-01

    To evaluate a novel microvascular anastomosis technique using N-fibroin stents. Cylinder stents of 1 mm diameter and 5 mm length were fabricated using N-fibroin from silkworms. In 22 rats, aortas were dissected, and the stent was inserted into the two ends of the aorta and fixed using methylmethacrylate. Stent anastomosis was successful in 21 (96%) rats. The mean ischemia time was 7.4 minutes, significantly shorter than the 15.9 minutes in the control group with conventional sutures (P stent anastomosis cases, and marked host rejection was evident at the stent anastomosis sites. Around the stents, thrombi were frequent (52%). Our study demonstrated the basic feasibility of stent anastomosis using N-fibroin stents and reduced ischemia time. However, thrombus formation, frequent and severe abdominal infections, and heavy host rejection remain critical issues. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Endoscopic stent suture fixation for prevention of esophageal stent migration during prolonged dilatation for achalasia treatment.

    Science.gov (United States)

    Rieder, E; Asari, R; Paireder, M; Lenglinger, J; Schoppmann, S F

    2017-04-01

    The aim of this study is to compare endoscopic stent suture fixation with endoscopic clip attachment or the use of partially covered stents (PCS) regarding their capability to prevent stent migration during prolonged dilatation in achalasia. Large-diameter self-expanding metal stents (30 mm × 80 mm) were placed across the gastroesophageal junction in 11 patients with achalasia. Stent removal was scheduled after 4 to 7 days. To prevent stent dislocation, endoscopic clip attachment, endoscopic stent suture fixation, or PCS were used. The Eckardt score was evaluated before and 6 months after prolonged dilatation. After endoscopic stent suture fixation, no (0/4) sutured stent migrated. When endoscopic clips were used, 80% (4/5) clipped stents migrated (p = 0.02). Of two PCS (n = 2), one migrated and one became embedded leading to difficult stent removal. Technical adverse events were not seen in endoscopic stent suture fixation but were significantly correlated with the use of clips or PCS (r = 0.828, p = 0.02). Overall, 72% of patients were in remission regarding their achalasia symptoms 6 months after prolonged dilatation. Endoscopic suture fixation of esophageal stents but not clip attachment appears to be the best method of preventing early migration of esophageal stents placed at difficult locations such as at the naive gastroesophageal junction. © The Authors 2017. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  17. Angulated Stents-A Novel Stent Improvisation to Manage Difficult Post-tuberculosis Bronchial Stenosis.

    Science.gov (United States)

    Tay, Chee Kiang; Jeong, Byeong-Ho; Kim, Hojoong

    2017-10-18

    Post-tuberculosis bronchostenosis (PTBS), a complication of endobronchial tuberculosis is currently treated by bronchial stenting. However, in cases of angulated bronchial stenoses, difficulty is often encountered in stent insertion and maintenance, resulting in stent migration, granulation tissue overgrowth, and restenosis. To accommodate the angulated alignment of the stenosis, we devised an "angulated stent"-a novel improvisation of the conventional stent via splicing and suturing to achieve a resultant angulated shape. A retrospective review was undertaken to evaluate the performance of this stent. Among 283 PTBS patients who underwent interventional bronchoscopy at our center from 2004 to 2014, 21 were treated with at least one angulated stent. Clinical outcomes, including the stenting duration were investigated. After a median follow-up of 26 months, stent removal was successful in 7 (33.3%) out of 21 patients. In patients managed with angulated stents, the median duration to stent change or eventual removal was longer than those treated with straight tube stents (392 days vs. 86 days; p < 0.05). Angulated stents are a feasible treatment option in patients with angulated PTBS by reducing complications and prolonging the stent-changing interval.

  18. Primary and revision efficacy of cross-wired metallic stents for endoscopic bilateral stent-in-stent placement in malignant hilar biliary strictures.

    Science.gov (United States)

    Lee, T H; Moon, J H; Kim, J H; Park, D H; Lee, S S; Choi, H J; Cho, Y D; Park, S H; Kim, S J

    2013-01-01

    Endoscopic bilateral drainage for inoperable malignant hilar biliary strictures (HBS) using metal stents is considered to be technically difficult. Furthermore, endoscopic revision of bilateral stenting after occlusion can be challenging. This study was performed to evaluate the long-term efficacy of endoscopic bilateral stent-in-stent placement of cross-wired metallic stents in high-grade malignant HBS and planned endoscopic bilateral revision. A total of 84 patients with inoperable high-grade malignant HBS were enrolled from three academic tertiary referral centers. Two cross-wired metal stents were inserted using a bilateral stent-in-stent placement method. Bilateral endoscopic revision was also performed during follow-up using either identical metal stents or plastic stents. The main outcome measurements were technical and functional success, complications, stent patency, and endoscopic revision efficacy. The technical and clinical success rates of endoscopic bilateral stent-in-stent placement of cross-wired metallic stents were 95.2% (80/84) and 92.9% (78/84), respectively. Median patency (range) and survival were 238 days (10-429) and 256 days (10-1130), respectively. Obstruction of primary bilateral stents occurred in 30.8% (24/78) of patients with functionally successful stent placement. The technical and clinical success rates of planned bilateral endoscopic revision for occluded stents were 83.3% (20/24) and 79.2% (19/24), respectively. For revision, bilateral metallic stents were placed in 11 patients (55.0%); the remaining patients received plastic stents. Palliative endoscopic bilateral stent-in-stent placement of cross-wired metallic stents was effective in patients with inoperable HBS. Revision endoscopic bilateral stenting may be feasible and successful in cases where the primary deployed metal stents are occluded. © Georg Thieme Verlag KG Stuttgart · New York.

  19. Endobronchial Occlusion Stent: A Preliminary Experimental Study

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Yo Won; Jeong, Woo Kyoung; Lee, Seoung Hoon; Heo, Jeong Nam; Jeon, Seok Chol [Hanyang University College of Medicine, Seoul (Korea, Republic of); Ko, Gi Young; Song, Ho Young [University of Ulsan College of Medicine, Ulsan (Korea, Republic of)

    2010-04-15

    To evaluate the safety and the technical feasibility of the use of an endobronchial occlusion stent and to get preliminary data for the development of the optimal material required for endobronchial occlusions. A commercialized, self-expandable tracheobronchial stent was modified; one half had a polyurethane cover with an occluded end and the other half was uncovered with a flaring configuration. The occluded end was placed such that it would face the distal lung. Under fluoroscopic guidance, seven stents were placed at the lower lobar bronchus in 6 mini-pigs. The bronchial obstruction was examined immediately after stent placement. Chest radiographs were taken at days 1, 7, 14, and 28 after stent placement and the removed airways from two, two, one, and one mini-pigs sacrificed on corresponding days were examined for the maintenance of bronchial obstruction. Stents were successfully placed and induced the immediate bronchial obstruction in all mini-pigs. Five of seven airways with occlusion stents maintained an obstruction until the mini-pigs were sacrificed. Proximal stent migration occurred in two mini-pigs (29%), and pulmonary consolidations were observed distal to four of the stents (57%). The placement of an endobronchial occlusion stent and the obstruction of targeted bronchi seem to be feasible, but an add-on check valve should be considered to prevent stent migration and obstructive pneumonia

  20. [Absorbable coronary stents. New promising technology].

    Science.gov (United States)

    Erbel, Raimund; Böse, Dirk; Haude, Michael; Kordish, Igor; Churzidze, Sofia; Malyar, Nasser; Konorza, Thomas; Sack, Stefan

    2007-06-01

    Coronary stent implantation started in Germany 20 years ago. In the beginning, the progress was very slow and accelerated 10 years later. Meanwhile, coronary stent implantation is a standard procedure in interventional cardiology. From the beginning of permanent stent implantation, research started to provide temporary stenting of coronary arteries, first with catheter-based systems, later with stent-alone technology. Stents were produced from polymers or metal. The first polymer stent implantation failed except the Igaki-Tamai stent in Japan. Newly developed absorbable polymer stents seem to be very promising, as intravascular ultrasound (IVUS) and optical coherence tomography have demonstrated. Temporary metal stents were developed based on iron and magnesium. Currently, the iron stent is tested in peripheral arteries. The absorbable magnesium stent (Biotronik, Berlin, Germany) was tested in peripheral arteries below the knee and meanwhile in the multicenter international PROGRESS-AMS (Clinical Performance and Angiographic Results of Coronary Stenting with Absorbable Metal Stents) study. The first magnesium stent implantation was performed on July 30, 2004 after extended experimental testing in Essen. The magnesium stent behaved like a bare-metal stent with low recoil of 5-7%. The stent struts were absorbed when tested with IVUS. Stent struts were not visible by fluoroscopy or computed tomography (CT) as well as magnetic resonance imaging (MRI). That means, that the magnesium stent is invisible and therefore CT and MRI can be used for imaging of interventions. Only using micro-CT the stent struts were visible. The absorption process could be demonstrated in a patient 18 days after implantation due to suspected acute coronary syndrome, which was excluded. IVUS showed a nice open lumen. Stent struts were no longer visible, but replaced by tissue indicating the previous stent location. Coronary angiography after 4 months showed an ischemia-driven target lesion

  1. A comparative evaluation of early stent occlusion among biliary conventional versus wing stents.

    Science.gov (United States)

    Khashab, Mouen A; Hutfless, Susan; Kim, Katherine; Lennon, Anne Marie; Canto, Marcia I; Jagannath, Sanjay B; Okolo, Patrick I; Shin, Eun Ji; Singh, Vikesh K

    2012-06-01

    Conventional plastic stents with a lumen typically have limited patency. The lumenless wing stent was engineered to overcome this problem. The objective of this study was to compare the incidence of early stent occlusion (symptomatic occlusion/cholangitis necessitating re-insertion within 90 days) for wing stents and conventional plastic stents. Patients with biliary pathology treated with plastic biliary stenting during the period 2003-2009 comprised the study cohort. Patients who had at least one biliary wing stent placed comprised the wing stent group, whereas patients who underwent only conventional stent plastic placement comprised the conventional stent group. Patients were stratified by indication: benign biliary strictures (group 1), malignant biliary strictures (group 2), or benign biliary non-stricture pathology (group 3). The association of stent type with the occurrence of primary outcome by indication was analyzed by use of multivariable logistic regression. Three-hundred and forty-six patients underwent 612 ERCP procedures with placement of plastic biliary stent(s). On multivariate analysis, early stent occlusion did not differ between the wing and conventional groups in groups 1, 2, and 3. Among patients who achieved primary outcome in group 2, significantly fewer patients in the wing group had cholangitis (6.7% vs. 39.1%, P = 0.03). Among patients who achieved primary outcome in group 3, significantly fewer patients in the wing group had cholangitis (10% vs. 50%, P = 0.03). Early stent occlusion was similar for wing stents and conventional plastic stents. Wing stents, however, were associated with a lower incidence of cholangitis in patients with malignant biliary obstruction and benign non-stricturing biliary pathology.

  2. Sutureless choledochoduodenostomy with an intraluminal degradable stent in dog model

    Institute of Scientific and Technical Information of China (English)

    ZHU Ling-hua; LIANG Xiao; LIN Hui; WANG Yi-fan; ZHU Yi-ping; CAI Xiu-jun

    2011-01-01

    Background It is difficult and time-consuming for carrying out conventional hand-sewn bilioenteric anastomosis, especially for small bile duct anastomosis and laparoscopic procedure. In order to simplify it, we have developed a novel procedure of sutureless bilioenteric anastomosis with an intraluminal degradable stent. This study aimed to evaluate the feasibility and safety of this technique with cholangioduodenostomy in dog model.Methods A patent intraluminal degradable stent tube for sutureless choledochoduodenostomy in dog model was made with polylactic acid in diameter of 3 mm or 4 mm. Thirty-eight dogs were randomly divided into to a stent group (SG, n=20) and a control group (CG, n=18). Dogs in the SG underwent sutureless choledochoduodenostomy with intraluminal stent, while the CG underwent conventional choledochoduodenostomy (single layer discontinuous anastomosis with absorbable suture). Dogs of each group were divided into 4 subgroups according to time of death (1,3,6, and 12 months postoperatively) to evaluate the healing of anastomosis. Operation time, intraoperative tolerance pressure of anastomosis, rate of postoperative bile leakage, bursting pressure of anastomosis were compared between the two groups. Anastomosis tissue was observed afterwards by pathology evaluation, hydroxyproline content, serum bilirubin, liver enzyme level and magnetic resonance cholangio-pancreatography (MRCP) to assess the stricture.Results All procedures were completed successfully. The surgical time of the SG was significantly less than the CG (SG: (19.2±4.3) minutes, vs. CG: (29.2±7.1) minutes, P=0.000). One bile leakage was occurred in either group. No significant difference of intraoperative tolerance pressure of anastomosis, rate of bile leakage and postoperative bursting pressure of anastomosis, anastomotic stricture, hydroxyproline content, serum bilirubin and liver enzyme level was found between the two groups. MRCP showed no anastomosis stricture and obstruction

  3. Recurrence of Subacute Stent Thrombosis and In-Stent Restenosis during Five Months after Stent Implantation in the LAD. A Case Report.

    OpenAIRE

    島田, 弘英; 大和, 眞史; 櫻井, 俊平; 疋田, 博之; 池田, 修一

    2001-01-01

    A coronary stent was deployed in the left anterior descending artery of an 82-year-old woman with unstable angina.Recurrence of subacute stent thrombosis and in-stent restenosis occurred frequently during the five months after initial stent implantation.Balloon angioplasty and cutting balloon angioplasty failed to prevent these complications,but they ceased after re-stenting in the initial stent.In this case,tissue protrusion through the stent strut, deformation of the coil stent and inadequa...

  4. Predictors of stent dysfunction after self-expandable metal stent placement for malignant gastric outlet obstruction: tumor ingrowth in uncovered stents and migration of covered stents.

    Science.gov (United States)

    Hori, Yasuki; Naitoh, Itaru; Hayashi, Kazuki; Ban, Tesshin; Natsume, Makoto; Okumura, Fumihiro; Nakazawa, Takahiro; Takada, Hiroki; Hirano, Atsuyuki; Jinno, Naruomi; Togawa, Shozo; Ando, Tomoaki; Kataoka, Hiromi; Joh, Takashi

    2017-10-01

    Endoscopic metallic stenting is widely accepted as a palliation therapy for malignant gastric outlet obstruction (GOO). However, the predictors of stent dysfunction have not been clarified. We aimed to evaluate the predictors, especially tumor ingrowth in uncovered self-expandable metallic stents (U-SEMS) and migration of covered self-expandable metallic stents (C-SEMS), which are the main causes related to the stent characteristics. In this multicenter retrospective study, we compared patients with U-SEMS and C-SEMS in terms of clinical outcomes, and predictors of stent dysfunction. In total, 252 patients (126 with U-SEMS and 126 with C-SEMS) were enrolled. There were no significant differences in technical success, clinical success, GOO score, or time to stent dysfunction. Tumor ingrowth was significantly more frequent in U-SEMS (U-SEMS, 11.90% vs. C-SEMS, 0.79%; p = 0.002), and stent migration was significantly more frequent for C-SEMS (C-SEMS, 8.73% vs. U-SEMS, 0.79%; p = 0.005). Karnofsky performance status (p = 0.04), no presence of ascites (p = 0.02), and insufficient (stent expansion (p = 0.003) were significantly associated with tumor ingrowth in U-SEMS. Meanwhile, a shorter stent length (p = 0.05) and chemotherapy (p = 0.03) were predictors of C-SEMS migration. Both U-SEMS and C-SEMS are effective with comparable patencies. Tumor ingrowth and stent migration are the main causes of stent dysfunction for U-SEMS and C-SEMS, respectively. With regard to stent dysfunction, U-SEMS might be a good option for patients receiving chemotherapy, while C-SEMS with longer stents for patients in good condition. (Clinical trial registration number: UMIN000024059).

  5. Clinical experience in coronary stenting with the Vivant Z Stent.

    Science.gov (United States)

    Chee, K H; Siaw, F S; Chan, C G; Chong, W P; Imran, Z A; Haizal, H K; Azman, W; Tan, K H

    2005-06-01

    This single centre study was designed to demonstrate feasibility, safety and efficacy of the Vivant Z stent (PFM AG, Cologne, Germany). Patients with de novo lesion were recruited. Coronary angioplasty was performed with either direct stenting or after balloon predilatation. Repeated angiogram was performed 6 months later or earlier if clinically indicated. Between January to June 2003, a total of 50 patients were recruited (mean age 55.8 +/- 9 years). A total of 52 lesions were stented successfully. Mean reference diameter was 2.77 mm (+/-0.59 SD, range 2.05-4.39 mm) with mean target lesion stenosis of 65.5% (+/-11.6 SD, range 50.1-93.3%). Forty-six lesions (88.5%) were American College of Cardiologist/American Heart Association class B/C types. Direct stenting was performed in 18 (34.6%) lesions. Mean stent diameter was 3.18 mm (+/-0.41 SD, range 2.5-4 mm), and mean stent length was 14.86 mm (+/-2.72 SD, range 9-18 mm). The procedure was complicated in only one case which involved the loss of side branch with no clinical sequelae. All treated lesions achieved Thrombolysis In Myocardial Infarction 3 flow. Mean residual diameter stenosis was 12.2% (+/-7.55 SD, range 0-22.6%) with acute gain of 1.72 mm (+/-0.50 SD, range 0.5-2.8). At 6 months, there was no major adverse cardiovascular event. Repeated angiography after 6 months showed a restenosis rate of 17% (defined as >50% diameter restenosis). Mean late loss was 0.96 mm (+/-0.48 SD) with loss index of 0.61 (+/-0.38 SD). The restenosis rate of those lesions less than 3.0 mm in diameter was 22.2% compared with 6.25% in those lesions more than 3.0 mm in diameter. The Vivant Z stent was shown to be safe and efficacious with low restenosis rate in de novo coronary artery lesion.

  6. A method to determine the kink resistance of stents and stent delivery systems according to international standards

    Directory of Open Access Journals (Sweden)

    Brandt-Wunderlich Christoph

    2016-09-01

    Full Text Available The kink behavior of vascular stents is of particular interest for clinicians, stent manufacturers and regulatory as a kinked stent generates a lumen loss in the stented vessel and can lead to in-stent restenosis. In this study methods to determine the kink resistance of stents and stent delivery systems according to the ISO 25539-2 and FDA guidance no. 1545 were presented. The methods are applicable for balloon expandable stents as well as for self-expanding stents and determine the lumen loss and residual diameter change dependent on the specific bending radius.

  7. An in Vitro Twist Fatigue Test of Fabric Stent-Grafts Supported by Z-Stents vs. Ringed Stents

    Directory of Open Access Journals (Sweden)

    Jing Lin

    2016-02-01

    Full Text Available Whereas buckling can cause type III endoleaks, long-term twisting of a stent-graft was investigated here as a mechanism leading to type V endoleak or endotension. Two experimental device designs supported with Z-stents having strut angles of 35° or 45° were compared to a ringed control under accelerated twisting. Damage to each device was assessed and compared after different durations of twisting, with focus on damage that may allow leakage. Stent-grafts with 35° Z-stents had the most severe distortion and damage to the graft fabric. The 45° Z-stents caused less fabric damage. However, consistent stretching was still seen around the holes for sutures, which attach the stents to the graft fabric. Larger holes may become channels for fluid percolation through the wall. The ringed stent-graft had the least damage observed. Stent apexes with sharp angles appear to be responsible for major damage to the fabrics. Device manufacturers should consider stent apex angle when designing stent-grafts, and ensure their devices are resistant to twisting.

  8. Stent malapposition, as a potential mechanism of very late stent thrombosis after bare-metal stent implantation: A case report

    Energy Technology Data Exchange (ETDEWEB)

    Higuma, Takumi, E-mail: higuma@cc.hirosaki-u.ac.jp; Abe, Naoki; Hanada, Kenji; Yokoyama, Hiroaki; Tomita, Hirofumi; Okumura, Ken

    2014-04-15

    A 90-year-old man was admitted to our hospital with acute ST-segment elevation myocardial infarction. He had a history of post-infarction angina pectoris 79 months ago and had a bare-metal stent (BMS) implanted in the proximal left anterior descending artery at our hospital. Emergent coronary angiography demonstrated thrombotic occlusion in the previously stented segment. After catheter thrombectomy, antegrade flow was restored, but 90% stenosis with haziness persisted in the proximal and distal portions of the previously stented segment. Intravascular ultrasound imaging showed interstrut cavities or stent malapposition at the proximal and distal sites of stented segment. In close proximity to the sites, residual thrombi were also observed. Optical coherence tomography (OCT) demonstrated neither lipid-laden neointimal tissue nor rupture but clearly demonstrated residual thrombus adjacent to the malapposed region in addition to the stent malapposition. PCI with balloon was successfully performed and stent apposition was confirmed by OCT. Stent malapposition is an unusual mechanism of very late stent thrombosis after BMS implantation. OCT can clearly reveal the etiology of stent thrombosis.

  9. An in Vitro Twist Fatigue Test of Fabric Stent-Grafts Supported by Z-Stents vs. Ringed Stents.

    Science.gov (United States)

    Lin, Jing; Guidoin, Robert; Du, Jia; Wang, Lu; Douglas, Graeham; Zhu, Danjie; Nutley, Mark; Perron, Lygia; Zhang, Ze; Douville, Yvan

    2016-02-16

    Whereas buckling can cause type III endoleaks, long-term twisting of a stent-graft was investigated here as a mechanism leading to type V endoleak or endotension. Two experimental device designs supported with Z-stents having strut angles of 35° or 45° were compared to a ringed control under accelerated twisting. Damage to each device was assessed and compared after different durations of twisting, with focus on damage that may allow leakage. Stent-grafts with 35° Z-stents had the most severe distortion and damage to the graft fabric. The 45° Z-stents caused less fabric damage. However, consistent stretching was still seen around the holes for sutures, which attach the stents to the graft fabric. Larger holes may become channels for fluid percolation through the wall. The ringed stent-graft had the least damage observed. Stent apexes with sharp angles appear to be responsible for major damage to the fabrics. Device manufacturers should consider stent apex angle when designing stent-grafts, and ensure their devices are resistant to twisting.

  10. Long-term results after carotid artery stenting. Restenosis after carotid artery stenting using self-expandable stent

    International Nuclear Information System (INIS)

    Matsumoto, Yasushi; Furui, Eisuke; Tsuboi, Ken; Takahashi, Akira; Ezura, Masayuki

    2008-01-01

    Carotid artery stenting has emerged as an acceptable treatment alternative in patients with carotid artery stenosis. Although early clinical results of carotid artery stenting have shown promise, long, term clinical results remain less certain. We report the frequency, management, and clinical results of in-stent restenosis after carotid artery stenting using a self-expandable stent. Between August 1998 and September 2004, 80 carotid artery stenting procedures in 78 patients were performed. We evaluated 76 of the 80 procedures in 75 of the 78 patients treated during this period who had a minimum 6-month clinical and imaging (ultrasound and/or magnetic resonance angiography) follow-up. Recurrent stenosis (≥50%) after carotid artery stenting occurred in 3 (3.9%) patients. The recurrent stenosis occurred within one year after the procedure in all cases. The low rate of in-stent restenosis using self-expandable stent suggested that carotid artery stenting may be an effective alternative treatment for carotid artery stenosis, but more data of long-term follow-up are required. (author)

  11. Comparison of a New Polytetrafluoroethylene-Covered Metallic Stent to a Noncovered Stent in Canine Ureters

    International Nuclear Information System (INIS)

    Chung, Hwan-Hoon; Lee, Seung Hwa; Cho, Sung Bum; Park, Hong Suk; Kim, Young Sik; Kang, Byung Chul; Frisoli, Joan K.; Razavi, Mahmood K.

    2008-01-01

    The aim of this study was to determine the feasibility of using a newly designed polytetrafluoroethylene (PTFE)-covered metallic stent in the ureter by comparing its effectiveness with that of the noncovered stent in a canine model. We placed 14 stents in the ureters of seven mongrel dogs that weighed 30-40 kg each. The covered and noncovered stents were deployed in the right and left ureters, respectively, of six dogs. In the seventh dog, a covered stent and a double-J catheter were inserted in the right ureter, and a covered stent only was inserted in the left ureter. The first six dogs were sacrificed at 5, 10, and 15 weeks after deployment of the stents (two for each follow-up period), and the seventh dog was sacrificed at 30 weeks. There was no migration or poor expansion of any of the stents observed on plain radiography. On intravenous pyelogram and retrograde pyelogram, all of the covered stents at each follow-up period had patent lumens at the stented segments without hydronephrosis, and the passage of contrast material through it was well preserved. The noncovered stents in the dogs sacrificed at 5 and 10 weeks and one of the two dogs sacrificed at 15 weeks showed near-complete occlusion of the stent lumen due to ingrowth of the soft tissue, and severe hydronephrosis was also noted. The noncovered stent in the other dog sacrificed at 15 weeks showed the passage of contrast material without hydronephrosis, but the lumen of the stent was still nearly occluded by the soft tissue. There was no evidence of hydronephrosis or passage disturbance of the contrast material in both ureters of the dog sacrificed at 30 weeks. We conclude that the newly designed PTFE-covered stent effectively prevented the luminal occlusion caused by urothelial hyperplasia compared to the near-total occlusion of the noncovered stents, and no migration of the covered stents was noted

  12. MR Angiography of Peripheral Arterial Stents: In Vitro Evaluation of 22 Different Stent Types

    Directory of Open Access Journals (Sweden)

    Matthias C. Burg

    2011-01-01

    Full Text Available Purpose. To evaluate stent lumen visibility of a large sample of different peripheral arterial (iliac, renal, carotid stents using magnetic resonance angiography in vitro. Materials and Methods. 21 different stents and one stentgraft (10 nitinol, 7 316L, 2 tantalum, 1 cobalt superalloy, 1 PET + cobalt superalloy, and 1 platinum alloy were examined in a vessel phantom (vessel diameters ranging from 5 to 13 mm filled with a solution of Gd-DTPA. Stents were imaged at 1.5 Tesla using a T1-weighted 3D spoiled gradient-echo sequence. Image analysis was performed measuring three categories: Signal intensity in the stent lumen, lumen visibility of the stented lumen, and homogeneity of the stented lumen. The results were classified using a 3-point scale (good, intermediate, and poor results. Results. 7 stents showed good MR lumen visibility (4x nitinol, 2x tantalum, and 1x cobalt superalloy. 9 stents showed intermediate results (5x nitinol, 2x 316L, 1x PET + cobalt superalloy, and 1x platinum alloy and 6 stents showed poor results (1x nitinol, and 5x 316L. Conclusion. Stent lumen visibility varies depending on the stent material and type. Some products show good lumen visibility which may allow the detection of stenoses inside the lumen, while other products cause artifacts which prevent reliable evaluation of the stent lumen with this technique.

  13. Pyeloplasty for hydronephrosis: Issues of double J stent versus nephrostomy tube as drainage technique

    Directory of Open Access Journals (Sweden)

    Ravi Kumar Garg

    2015-01-01

    Full Text Available Aims: To compare the efficacy, complications, cost analysis and hospital stay between two methods of drainage of the kidney: double J (DJ stent versus nephrostomy tube following open pyeloplasty for ureteropelvic junction obstruction hydronephrosis. Patients and Methods: This was a prospective randomized study of 20 patients in each group over 14 months. Pre and post-operative (3 months function and drainage were assessed by ethylenedicysteine scan and intravenous urogram. Results: Both groups showed similar good improvement in function and drainage. Nephrostomy group had significantly longer hospital stay (P < 0.001 but incurred less cost. Complications with nephrostomy included tube breakage (n = 1 and urine leak after tube removal (n = 2. DJ stents were associated with stent migration (n = 4, increased frequency of micturition (n = 9, dysuria (n = 4 and urinary tract infection (n = 1. Conclusion: Both methods of drainage did not interfere with improvement after pyeloplasty. Minor complications were more with DJ stent (P = 0.0003. Although overall cost of treatment was more with stents, they reduced length of hospital stay. Optimal length of stent is essential to reduce complications secondary to migration and bladder irritation.

  14. Polymeric Biodegradable Stent Insertion in the Esophagus

    Directory of Open Access Journals (Sweden)

    Kai Yang

    2016-04-01

    Full Text Available Esophageal stent insertion has been used as a well-accepted and effective alternative to manage and improve the quality of life for patients diagnosed with esophageal diseases and disorders. Current stents are either permanent or temporary and are fabricated from either metal or plastic. The partially covered self-expanding metal stent (SEMS has a firm anchoring effect and prevent stent migration, however, the hyperplastic tissue reaction cause stent restenosis and make it difficult to remove. A fully covered SEMS and self-expanding plastic stent (SEPS reduced reactive hyperplasia but has a high migration rate. The main advantage that polymeric biodegradable stents (BDSs have over metal or plastic stents is that removal is not require and reduce the need for repeated stent insertion. But the slightly lower radial force of BDS may be its main shortcoming and a post-implant problem. Thus, strengthening support of BDS is a content of the research in the future. BDSs are often temporarily effective in esophageal stricture to relieve dysphagia. In the future, it can be expect that biodegradable drug-eluting stents (DES will be available to treat benign esophageal stricture, perforations or leaks with additional use as palliative modalities for treating malignant esophageal stricture, as the bridge to surgery or to maintain luminal patency during neoadjuvant chemoradiation.

  15. Stent Design Affects Femoropopliteal Artery Deformation.

    Science.gov (United States)

    MacTaggart, Jason; Poulson, William; Seas, Andreas; Deegan, Paul; Lomneth, Carol; Desyatova, Anastasia; Maleckis, Kaspars; Kamenskiy, Alexey

    2018-03-23

    Poor durability of femoropopliteal artery (FPA) stenting is multifactorial, and severe FPA deformations occurring with limb flexion are likely involved. Different stent designs result in dissimilar stent-artery interactions, but the degree of these effects in the FPA is insufficiently understood. To determine how different stent designs affect limb flexion-induced FPA deformations. Retrievable markers were deployed into n = 28 FPAs of lightly embalmed human cadavers. Bodies were perfused and CT images were acquired with limbs in the standing, walking, sitting, and gardening postures. Image analysis allowed measurement of baseline FPA foreshortening, bending, and twisting associated with each posture. Markers were retrieved and 7 different stents were deployed across the adductor hiatus in the same limbs. Markers were then redeployed in the stented FPAs, and limbs were reimaged. Baseline and stented FPA deformations were compared to determine the influence of each stent design. Proximal to the stent, Innova, Supera, and SmartFlex exacerbated foreshortening, SmartFlex exacerbated twisting, and SmartControl restricted bending of the FPA. Within the stent, all devices except Viabahn restricted foreshortening; Supera, SmartControl, and AbsolutePro restricted twisting; SmartFlex and Innova exacerbated twisting; and Supera and Viabahn restricted bending. Distal to the stents, all devices except AbsolutePro and Innova exacerbated foreshortening, and Viabahn, Supera, Zilver, and SmartControl exacerbated twisting. All stents except Supera were pinched in flexed limb postures. Peripheral self-expanding stents significantly affect limb flexion-induced FPA deformations, but in different ways. Although certain designs seem to accommodate some deformation modes, no device was able to match all FPA deformations.

  16. [Prospective evaluation of pain associated with indwelling JJ stents following ureterorenoscopic lithotripsy].

    Science.gov (United States)

    Dudek, Przemysław; Gołabek, Tomasz; Jaskulski, Jarosław; Orłowski, Paweł; Bukowczan, Jakub; Szopiński, Tomasz; Chłosta, Piotr

    2013-01-01

    Routine placement of JJ ure teric stents, following uncomplicated endoscopic removal of a ureteral stone, still remains debatable. Indwelling JJ stents are not without any risks. They often can cause marked discomfort, or even pain. The aim of this study was to prospectively evaluate patient's perceived pain due to renal colic and indwelling JJ stent left following ure terorenoscopic lithotripsy (URSL). 54 patients with colicky pain due to distal ureteric stone, and who underwent uncompli cated ureterorenoscopic lithotripsy, were included in the study. Follow ing URSL, patients were randomly selected to have either JJ stent left in situ (Group I), or remain without a stent (Group II). Among all study par ticipants levels of pain prior, as well as 14 days after the procedure were evalu ated with the use of a visual analogue pain scale. Pain perception at the time of colic did not vary between men and women (6.30 +/- 1.33 and 6.38 +/- 1.11, respectively, p=0.293). Similarly, no differences in perceived pain were noted 14 days following URSL. Mean pain score in patients with indwelling JJ stent was 2.12 +/- 1.23 as compared to 2.15 +/- 0.67 in those without it (p=0.148). No increase in pain levels due to indwelling JJ stent could be observed. Further research to allow for better assessment of discomfort and pain caused by an indwelling JJ stent on a larger cohort, and which could also discriminate patients' psy chosomatic symptoms, is needed.

  17. Acute ST-Elevation Myocardial Infarction after Coronary Stent Fracture.

    Science.gov (United States)

    Rafighdust, Abbasali; Eshraghi, Ali

    2015-10-27

    The invention of the drug-eluting stent (DES) has brought about revolutionary changes in the field of interventional cardiology. In the DES era, in-stent restenosis has declined but new issues such as stent thrombosis have emerged. One of the emerging paradigms in the DES era is stent fracture. There are reports about stent fracture leading to in-stent restenosis or stent thrombosis. Most of these reports concern the Sirolimus-eluting stent. The present case is a representation of a Biolimus-eluting stent fracture. We introduce a 64-year-old male patient, for whom the BioMatrix stent was deployed in the right coronary artery. Five months after the implantation, he experienced acute myocardial infarction, with stent fracture leading to stent thrombosis being the causative mechanism. Another DES (Cypher) was used to manage this situation, and the final result was good.

  18. Causes and prevention of in-stent restenosis of vertebral artery origin after stenting

    International Nuclear Information System (INIS)

    Zhao Huipin; Li Shenmao; Zhang Guangping

    2010-01-01

    Vertebral artery stenosis is an important cause of posterior circulation stroke. Vertebral artery stenosis most commonly occurs at its origin site. In recent years, balloon angioplasty and stent implantation have been widely employed in the treatment of vertebral artery origin stenosis. However, the long term outcome of stent implantation is affected by in-stent restenosis. Multiple contributory factors have been identified, but clear understanding of the overall underlying mechanism remains an enigma. With the development of pathophysiology, prevention and treatment methods of in-stent restenosis have been improved. In recent years, drug-eluting stents, radioactive stents and magnetic stents have been widely applied. To some extent, these stents and drug therapy can solve the problem of restenosis. This article aims to review the clinical application and the up-to-date research progresses in preventing and managing vertebral artery origin restenosis. (authors)

  19. Evaluation of a novel stent technology: the Genous EPC capturing stent

    NARCIS (Netherlands)

    Klomp, M.

    2012-01-01

    Tegenwoordig gebruiken ziekenhuizen een nieuwe stent bij dotterbehandelingen van kransslagadervernauwingen. Deze Genous-stent heeft een laag met antistoffen waardoor het behandelde bloedvat snel bedekt raakt met lichaamseigen cellen. Zo wordt tegengegaan dat er opnieuw een vernauwing optreedt of dat

  20. Clinical outcomes of self-expandable stent placement for benign esophageal diseases: A pooled analysis of the literature

    Science.gov (United States)

    van Halsema, Emo E; van Hooft, Jeanin E

    2015-01-01

    AIM: To analyze the outcomes of self-expandable stent placement for benign esophageal strictures and benign esophageal leaks in the literature. METHODS: The PubMed, Embase and Cochrane databases were searched for relevant articles published between January 2000 and July 2014. Eight prospective studies were identified that analyzed the outcomes of stent placement for refractory benign esophageal strictures. The outcomes of stent placement for benign esophageal leaks, perforations and fistulae were extracted from 20 retrospective studies that were published after the inclusion period of a recent systematic review. Data were pooled and analyzed using descriptive statistics. RESULTS: Fully covered self-expandable metal stents (FC SEMS) (n = 85), biodegradable (BD) stents (n = 77) and self-expandable plastic stents (SEPS) (n = 70) were inserted in 232 patients with refractory benign esophageal strictures. The overall clinical success rate was 24.2% and according to stent type 14.1% for FC SEMS, 32.9% for BD stents and 27.1% for SEPS. Stent migration occurred in 24.6% of cases. The overall complication rate was 31.0%, including major (17.7%) and minor (13.4%) complications. A total of 643 patients were treated with self-expandable stents mainly for postsurgical leaks (64.5%), iatrogenic perforations (19.6%), Boerhaave’s syndrome (7.8%) and fistulae (3.7%). FC SEMS and partially covered SEMS were used in the majority of patients. Successful closure of the defect was achieved in 76.8% of patients and according to etiology in 81.4% for postsurgical leaks, 86.0% for perforations and 64.7% for fistulae. The pooled stent migration rate was 16.5%. Stent-related complications occurred in 13.4% of patients, including major (7.8%) and minor (5.5%) complications. CONCLUSION: The outcomes of stent placement for refractory benign esophageal strictures were poor. However, randomized trials are needed to put this into perspective. The evidence on successful stent placement for benign

  1. Clinical outcomes of self-expandable stent placement for benign esophageal diseases: A pooled analysis of the literature.

    Science.gov (United States)

    van Halsema, Emo E; van Hooft, Jeanin E

    2015-02-16

    To analyze the outcomes of self-expandable stent placement for benign esophageal strictures and benign esophageal leaks in the literature. The PubMed, Embase and Cochrane databases were searched for relevant articles published between January 2000 and July 2014. Eight prospective studies were identified that analyzed the outcomes of stent placement for refractory benign esophageal strictures. The outcomes of stent placement for benign esophageal leaks, perforations and fistulae were extracted from 20 retrospective studies that were published after the inclusion period of a recent systematic review. Data were pooled and analyzed using descriptive statistics. Fully covered self-expandable metal stents (FC SEMS) (n = 85), biodegradable (BD) stents (n = 77) and self-expandable plastic stents (SEPS) (n = 70) were inserted in 232 patients with refractory benign esophageal strictures. The overall clinical success rate was 24.2% and according to stent type 14.1% for FC SEMS, 32.9% for BD stents and 27.1% for SEPS. Stent migration occurred in 24.6% of cases. The overall complication rate was 31.0%, including major (17.7%) and minor (13.4%) complications. A total of 643 patients were treated with self-expandable stents mainly for postsurgical leaks (64.5%), iatrogenic perforations (19.6%), Boerhaave's syndrome (7.8%) and fistulae (3.7%). FC SEMS and partially covered SEMS were used in the majority of patients. Successful closure of the defect was achieved in 76.8% of patients and according to etiology in 81.4% for postsurgical leaks, 86.0% for perforations and 64.7% for fistulae. The pooled stent migration rate was 16.5%. Stent-related complications occurred in 13.4% of patients, including major (7.8%) and minor (5.5%) complications. The outcomes of stent placement for refractory benign esophageal strictures were poor. However, randomized trials are needed to put this into perspective. The evidence on successful stent placement for benign esophageal leaks, perforations and

  2. Effect of cilostazol on in-stent neointimal hyperplasia after coronary artery stenting. A quantitative coronary angiography and volumetric intravascular ultrasound study

    International Nuclear Information System (INIS)

    Min, Pil-Ki; Jung, Jae-Hun; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Shim, Won-Heum

    2007-01-01

    This study was designed to investigate the efficacy of cilostazol on the prevention of in-stent neointimal hyperplasia as measured by both quantitative coronary angiography (CAG) and volumetric intravascular ultrasound (IVUS). Fifty-nine patients (39 men, age 62 years) undergoing elective coronary stenting were randomly assigned to receive aspirin plus clopidogrel or ticlopidine (Group I, n=28, 30 lesions) or aspirin plus clopidogrel or ticlopidine plus cilostazol (Group II, n=31, 35 lesions). CAG and IVUS were performed and repeated at 6 months to assess the primary endpoints of minimal luminal diameter (MLD) and in-stent neointimal hyperplasia volume. Follow-up CAG was performed on all patients and follow-up IVUS study was available for 50 lesions in 48 patients (24 lesions in Group I, 26 in Group II). There were no significant differences in the baseline angiographic data between the 2 groups. At 6 months follow-up, in-stent MLD was 1.90±0.76 mm in Group I and 2.41±0.85 mm in Group II (p=0.006). Volumetric IVUS at 6 months demonstrated that in-stent intimal hyperplasia volume per stent length was 2.2±1.4 mm 3 /mm in Group I and 1.0±0.5 mm 3 /mm in Group II (p=0.001). Triple antiplatelet therapy including cilostazol seems to be more effective at preventing in-stent neointimal hyperplasia than a dual antiplatelet regimen. (author)

  3. Comparison of self-expandable and balloon-expanding stents for hybrid ductal stenting in hypoplastic left heart complex.

    Science.gov (United States)

    Goreczny, Sebastian; Qureshi, Shakeel A; Rosenthal, Eric; Krasemann, Thomas; Nassar, Mohamed S; Anderson, David R; Morgan, Gareth J

    2017-07-01

    We aimed to compare the procedural and mid-term performance of a specifically designed self-expanding stent with balloon-expandable stents in patients undergoing hybrid palliation for hypoplastic left heart syndrome and its variants. The lack of specifically designed stents has led to off-label use of coronary, biliary, or peripheral stents in the neonatal ductus arteriosus. Recently, a self-expanding stent, specifically designed for use in hypoplastic left heart syndrome, has become available. We carried out a retrospective cohort comparison of 69 neonates who underwent hybrid ductal stenting with balloon-expandable and self-expanding stents from December, 2005 to July, 2014. In total, 43 balloon-expandable stents were implanted in 41 neonates and more recently 47 self-expanding stents in 28 neonates. In the balloon-expandable stents group, stent-related complications occurred in nine patients (22%), compared with one patient in the self-expanding stent group (4%). During follow-up, percutaneous re-intervention related to the ductal stent was performed in five patients (17%) in the balloon-expandable stent group and seven patients (28%) in self-expanding stents group. Hybrid ductal stenting with self-expanding stents produced favourable results when compared with the results obtained with balloon-expandable stents. Immediate additional interventions and follow-up re-interventions were similar in both groups with complications more common in those with balloon-expandable stents.

  4. Forgotten Ureteral Stents: An Avoidable Morbidity

    International Nuclear Information System (INIS)

    Murtaza, B.; Alvi, S.

    2016-01-01

    Objective: To assess the clinical presentation of forgotten ureteral stents and highlight the etiological factors resulting in the retention of these stents. Study Design: Observational study. Place and Duration of Study: Department of Urology, Armed Forces Institute of Urology, Rawalpindi, from January 2010 to Jun 2011. Methodology: Thirty-eight patients, with forgotten ureteral stents, retained for more than 6 months duration, were enrolled. A detailed evaluation was performed, along with the questions regarding the patients' opinion about the ureteral stents. They were specially asked whether they knew about the stents or were they formally informed regarding the stents. Subsequently, the patients were managed according to their clinical condition. Results: The male to female ratio was 2.1:1 aged 23 - 69 years, mean being 40.24 ± 12.59 years. The time of presentation after the ureteral stenting was 7 - 180 months (mean = 28.89 ± 33.435 years). Seven patients (18.4 percentage) reported with chronic kidney disease, including ESRD in two cases. Recurrent UTI was seen in 28 cases (73.6 percentage), calculus formed over the stents in 20 cases (52.6 percentage), and stent fragmented in 5 patients (13.1 percentage). Majority of patients, (n = 23, 60.5 percentage), were not even aware of the placement of these stents while 8 (21.0 percentage) knew but were reluctant about its removal. In 3 cases (7.8 percentage), the relatives knew about the stent but never informed the patients. The stent had been removed in 2 cases (5.2 percentage), but the other broken fragment was missed. One case (2.6 percentage) each had a misconception about the permanent placement of the stents like cardiac stents and regarding degradation of the stents in situ. Conclusion: Forgotten ureteral stents produce clinical features ranging from recurrent UTI to ESRD. This preventable urological complication is primarily due to the unawareness or ignorance of the patients and their relatives

  5. Effect of trimetazidine on recurrent angina pectoris and left ventricular structure in elderly multivessel coronary heart disease patients with diabetes mellitus after drug-eluting stent implantation: a single-centre, prospective, randomized, double-blind study at 2-year follow-up.

    Science.gov (United States)

    Xu, Xiaohan; Zhang, Weijun; Zhou, Yujie; Zhao, Yingxin; Liu, Yuyang; Shi, Dongmei; Zhou, Zhiming; Ma, Hanying; Wang, Zhijian; Yu, Miao; Ma, Qian; Gao, Fei; Shen, Hua; Zhang, Jianwei

    2014-04-01

    Trimetazidine has been shown to improve angina pectoris and left ventricular (LV) function in diabetic patients with ischaemic cardiomyopathy. The objective of this study was to evaluate the effects of trimetazidine on recurrent angina pectoris and LV structure after drug-eluting stent (DES) implantation in elderly multivessel coronary heart disease (CHD) patients with diabetes mellitus (DM) and a left ventricular ejection fraction (LVEF) of ≥ 50 %. This was a single-centre, prospective, randomized, double-blind evaluation study. Between January 2010 and September 2010, 700 CHD patients with DM who were aged ≥ 65 years and undergoing coronary angiography at An Zhen Hospital (Beijing, China) were recruited and prospectively randomized to receive trimetazidine (20 mg three times daily) or placebo after DES implantation as an addition to conventional CHD treatment. The primary end points were the incidence of recurrent angina pectoris and measures of various echocardiographic parameters, which included LVEF. At 2-year follow-up, patients in the trimetazidine group (n = 255) showed significant improvements in the incidence (P = 0.024) and severity of angina pectoris, compared with the control group, as well as silent myocardial ischaemia (P = 0.009) and angina pectoris-free survival (P = 0.011). LV function and structure in trimetazidine-treated patients were relatively stable at 2-year follow-up, while they deteriorated in the control group (n = 255) with a significant difference between groups (all P angina pectoris as well as LV function and structure in elderly multivessel CHD patients with DM.

  6. Self-Expandable Metal Stents and Trans-stent Light Delivery: Are Metal Stents and Photodynamic Therapy Compatible?

    Science.gov (United States)

    Wang, Luo-Wei; Li, Li-Bo; Li, Zhao-Shen; Chen, Yang K; Hetzel, Fred W.; Huang, Zheng

    2008-01-01

    Background and Objectives: Obstructive non-small cell lung cancer and obstructive esophageal cancer are US FDA approved indications of photodynamic therapy (PDT). The usefulness of PDT for the treatment of cholangiocarcinoma is currently under clinical investigation. Endoscopic stenting for lumen restoration is a common palliative intervention for those indications. It is important to assess whether self-expandable metal stents are compatible with trans-stent PDT light delivery. Study Design/Materials and Methods: Direct effects of various components of metal biliary (n = 2), esophageal (n = 2), and bronchial (n = 1) stents on PDT light transmittance and distribution were examined using a point or linear light source (630 or 652 nm diode laser). Resected pig biliary duct and esophageal wall tissues were used to examine the feasibility of PDT light delivery through the fully expanded metal stents. Results: While using a point light source, the metal components (thread and joint) of the stent could cause a significant shadow effect. The liner material (polytetrafluoroethylene or polyurethane) could cause various degrees of light absorption. When the stent was covered with a thin layer of biliary duct and esophageal tissues containing all wall layers, the shadow effect could be mitigated due to tissue scattering. Conclusions: This study clearly demonstrates that it is feasible to combine stenting and PDT for the treatment of luminal lesions. PDT light dose should be adjusted to counteract the reduction of light transmittance caused by the metal and liner materials of stent. PMID:18951422

  7. Prevention of stent thrombosis: challenges and solutions

    Science.gov (United States)

    Reejhsinghani, Risheen; Lotfi, Amir S

    2015-01-01

    Stent thrombosis is an uncommon but serious complication which carries with it significant mortality and morbidity. This review analyzes the entity of stent thrombosis from a historical and clinical perspective, and chronicles the evolution of this condition through the various generations of stent development, from bare metal to first-generation, second-generation, and third-generation drug-eluting stents. It also delineates the specific risk factors associated with stent thrombosis and comprehensively examines the literature related to each of these risks. Finally, it highlights the preventative strategies that can be garnered from the existing data, and concludes that a multifactorial approach is necessary to combat the occurrence of stent thrombosis, with higher risk groups, such as patients with ST segment elevation myocardial infarction, meriting further research. PMID:25657588

  8. Removal of retrievable self-expandable urethral stents: experience in 58 stents

    International Nuclear Information System (INIS)

    Shin, Ji Hoon; Song, Ho-Young; Kim, Jin Hyoung; Ko, Heung-Kyu; Kim, Yong Jae; Woo, Chul-Woong; Kim, Tae-Hyung; Ko, Gi-Young; Yoon, Hyun-Ki; Sung, Kyu-Bo; Park, Hyungkeun

    2006-01-01

    The purpose of this study was to retrospectively evaluate the safety and efficacy of removing retrievable self-expandable urethral stents using a retrieval hook wire. Under fluoroscopic guidance, the removal of 58 polyurethane or PTFE (polytetrafluoroethylene)-covered stents was attempted in 33 patients using a retrieval hook wire. Indications for removal were elective removal (n=21), stent migration (n=19), formation of tissue hyperplasia around or inside of the stent (n=14), stent deformity (n=3), and severe pain (n=1). The mean time the stents remained in place was 64.8±42.9 days (range, 1-177 days). Fifty-six (97%) of the 58 stents were successfully removed using the retrieval hook wire despite the following difficulties; hook wire disconnection (n=2), untied drawstrings (n=3), and polyurethane membrane disruption/separation (n=4). The removal procedure using a retrieval hook wire failed in two stents (3%) which had migrated into the urinary bladder. One of the two stents with migration into the urinary bladder was removed using a snare through the cystostomy route. The overall complication rate was 14% (seven hematuria cases and one urethral tear case), and all were minor and spontaneously resolved without further treatment. In conclusion, removal of retrievable urethral stents using a retrieval hook wire was safe and effective despite some technical difficulties. It is a useful method for allowing temporary stent placement and solving various complications of stent use. (orig.)

  9. Genous endothelial progenitor cell-capturing stent system: a novel stent technology

    NARCIS (Netherlands)

    Klomp, Margo; Beijk, Marcel A. M.; de Winter, Robbert J.

    2009-01-01

    Drug-eluting stents have been demonstrated to significantly reduce clinical and angiographic restenosis in patients with coronary artery disease compared with bare-metal stents. Intuitively, however, a prohealing approach for the prevention of in-stent restenosis by promoting accelerated

  10. Mechanical behavior of peripheral stents and stent-vessel interaction: A computational study

    Science.gov (United States)

    Dottori, Serena; Flamini, Vittoria; Vairo, Giuseppe

    2016-05-01

    In this paper stents employed to treat peripheral artery disease are analyzed through a three-dimensional finite-element approach, based on a large-strain and large-displacement formulation. Aiming to evaluate the influence of some stent design parameters on stent mechanics and on the biomechanical interaction between stent and arterial wall, quasi-static and dynamic numerical analyses are carried out by referring to computational models of commercially and noncommercially available versions of both braided self-expandable stents and balloon-expandable stents. Addressing isolated device models, opening mechanisms and flexibility of both opened and closed stent configurations are numerically experienced. Moreover, stent deployment into a stenotic peripheral artery and possible postdilatation angioplasty (the latter for the self-expandable device only) are simulated by considering different idealized vessel geometries and accounting for the presence of a stenotic plaque. Proposed results highlight important differences in the mechanical response of the two types of stents, as well as a significant influence of the vessel shape on the stress distributions arising upon the artery-plaque system. Finally, computational results are used to assess both the stent mechanical performance and the effectiveness of the stenting treatment, allowing also to identify possible critical conditions affecting the risk of stent fracture, tissue damage, and/or pathological tissue response.

  11. PulmoStent : In Vitro to In Vivo Evaluation of a Tissue Engineered Endobronchial Stent

    NARCIS (Netherlands)

    Thiebes, Anja Lena; Kelly, Nicola; Sweeney, Caoimhe A.; McGrath, Donnacha J.; Clauser, Johanna; Kurtenbach, Kathrin; Gesche, Valentine N.; Chen, Weiluan; Kok, Robbert Jan; Steinseifer, Ulrich; Bruzzi, Mark; O’Brien, Barry J.; McHugh, Peter E.; Jockenhoevel, Stefan; Cornelissen, Christian G.

    Currently, there is no optimal treatment available for end stage tumour patients with airway stenosis. The PulmoStent concept aims on overcoming current hurdles in airway stenting by combining a nitinol stent with a nutrient-permeable membrane, which prevents tumour ingrowth. Respiratory epithelial

  12. Removal of retrievable self-expandable urethral stents: experience in 58 stents

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Ji Hoon; Song, Ho-Young; Kim, Jin Hyoung; Ko, Heung-Kyu; Kim, Yong Jae; Woo, Chul-Woong; Kim, Tae-Hyung; Ko, Gi-Young; Yoon, Hyun-Ki; Sung, Kyu-Bo [Asan Medical Center, Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Seoul (Korea); Park, Hyungkeun [Asan Medical Center, Department of Urology, University of Ulsan College of Medicine, Seoul (Korea)

    2006-09-15

    The purpose of this study was to retrospectively evaluate the safety and efficacy of removing retrievable self-expandable urethral stents using a retrieval hook wire. Under fluoroscopic guidance, the removal of 58 polyurethane or PTFE (polytetrafluoroethylene)-covered stents was attempted in 33 patients using a retrieval hook wire. Indications for removal were elective removal (n=21), stent migration (n=19), formation of tissue hyperplasia around or inside of the stent (n=14), stent deformity (n=3), and severe pain (n=1). The mean time the stents remained in place was 64.8{+-}42.9 days (range, 1-177 days). Fifty-six (97%) of the 58 stents were successfully removed using the retrieval hook wire despite the following difficulties; hook wire disconnection (n=2), untied drawstrings (n=3), and polyurethane membrane disruption/separation (n=4). The removal procedure using a retrieval hook wire failed in two stents (3%) which had migrated into the urinary bladder. One of the two stents with migration into the urinary bladder was removed using a snare through the cystostomy route. The overall complication rate was 14% (seven hematuria cases and one urethral tear case), and all were minor and spontaneously resolved without further treatment. In conclusion, removal of retrievable urethral stents using a retrieval hook wire was safe and effective despite some technical difficulties. It is a useful method for allowing temporary stent placement and solving various complications of stent use. (orig.)

  13. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

    Sabaté, Manel; Windecker, Stephan; Iñiguez, Andres

    2015-01-01

    AIMS: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential...... to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES...... was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition...

  14. Complication after self expandable metallic stent for esophageal cancer

    International Nuclear Information System (INIS)

    Nagahama, Takeshi; Maruyama, Michio; Kato, Kiyomi; Shinoura, Hiroshi; Hasegawa, Kumi; Takashima, Itaru; Ebuchi, Masakazu

    2003-01-01

    Major complications after placement of esophageal stent and airway stent were reviewed and evaluated. Four patients, including two patients with perforations and two patients with fistula formation, developed major complications after placement of a self expandable metallic stent. Two patients underwent additional radiation to improve stricture after stent placement. In one patient, stent placement was selected to improve esophageal stricture that occurred after radical radiation therapy. In one patient, migration of stent into the lesion caused a perforation. It can be concluded that additional radiation after stent placement increases the risk of complication. Stent migration also can lead to the risk of perforation. (author)

  15. The current role of vascular stents.

    Science.gov (United States)

    Busquet, J

    1993-09-01

    The limitations of percutaneous balloon angioplasty have favoured the development and the use of vascular endoprostheses or stents. These thin-walled metal devices maintain after expansion, an optimal and constant diameter for the vascular lumen. Restenosis, dissection, abrupt closure, residual stenosis or re-opened total occlusion represent appropriate indications for stenting. A large experience with non-coronary application of stents is currently available in iliac, femoro-popliteal and renal arteries, aorta, large veins.

  16. Stent implantation influence wall shear stress evolution

    Science.gov (United States)

    Bernad, S. I.; Totorean, A. F.; Bosioc, A. I.; Petre, I.; Bernad, E. S.

    2016-06-01

    Local hemodynamic factors are known affect the natural history of the restenosis critically after coronary stenting of atherosclerosis. Stent-induced flows disturbance magnitude dependent directly on the strut design. The impact of flow alterations around struts vary as the strut geometrical parameters change. Our results provide data regarding the hemodynamic parameters for the blood flow in both stenosed and stented coronary artery under physiological conditions, namely wall shear stress and pressure drop.

  17. Management of JJ stent-related symptoms.

    Science.gov (United States)

    Papatsoris, Athanasios; Dellis, Athanasios; Daglas, George; Sanguedolce, Francesco

    2014-01-01

    Ureteric JJ stents are inserted in numerous pa- tients as a routine procedure. Nevertheless, the ideal JJ stent that does not cause any lower urinary tract symptoms has not been developed yet. Even special validated ques- tionnaires have been used for the assessment of JJ stent-related symtoms. For the management of such symtoms usually alpha-blockers are admin- istered. Also, studies have examined the efficacy and safety of anticholinergics and calcium channel blo- ckers. In this article we review the literature upon the management of JJ stent-related symptoms.

  18. Configuration affects parallel stent grafting results.

    Science.gov (United States)

    Tanious, Adam; Wooster, Mathew; Armstrong, Paul A; Zwiebel, Bruce; Grundy, Shane; Back, Martin R; Shames, Murray L

    2018-05-01

    A number of adjunctive "off-the-shelf" procedures have been described to treat complex aortic diseases. Our goal was to evaluate parallel stent graft configurations and to determine an optimal formula for these procedures. This is a retrospective review of all patients at a single medical center treated with parallel stent grafts from January 2010 to September 2015. Outcomes were evaluated on the basis of parallel graft orientation, type, and main body device. Primary end points included parallel stent graft compromise and overall endovascular aneurysm repair (EVAR) compromise. There were 78 patients treated with a total of 144 parallel stents for a variety of pathologic processes. There was a significant correlation between main body oversizing and snorkel compromise (P = .0195) and overall procedural complication (P = .0019) but not with endoleak rates. Patients were organized into the following oversizing groups for further analysis: 0% to 10%, 10% to 20%, and >20%. Those oversized into the 0% to 10% group had the highest rate of overall EVAR complication (73%; P = .0003). There were no significant correlations between any one particular configuration and overall procedural complication. There was also no significant correlation between total number of parallel stents employed and overall complication. Composite EVAR configuration had no significant correlation with individual snorkel compromise, endoleak, or overall EVAR or procedural complication. The configuration most prone to individual snorkel compromise and overall EVAR complication was a four-stent configuration with two stents in an antegrade position and two stents in a retrograde position (60% complication rate). The configuration most prone to endoleak was one or two stents in retrograde position (33% endoleak rate), followed by three stents in an all-antegrade position (25%). There was a significant correlation between individual stent configuration and stent compromise (P = .0385), with 31

  19. Endovascular AAA exclusion: will stents with hooks and barbs prevent stent-graft migration?

    Science.gov (United States)

    Malina, M; Lindblad, B; Ivancev, K; Lindh, M; Malina, J; Brunkwall, J

    1998-11-01

    To investigate if stents with hooks and barbs will improve stent-graft fixation in the abdominal aorta. Sixteen- to 24-mm-diameter Dacron grafts were deployed inside cadaveric aortas. The grafts were anchored by stents as in endovascular abdominal aortic aneurysm repair. One hundred thirty-seven stent-graft deployments were carried out with modified self-expanding Z-stents with (A) no hooks and barbs (n = 75), (B) 4 5-mm-long hooks and barbs (n = 39), (C) 8 10-mm-long, strengthened hooks and barbs (n = 19), or (D) hooks only (n = 4). Increasing longitudinal traction was applied to determine the displacement force needed to extract the stent-grafts. The radial force of the stents was measured and correlated to the displacement force. The median (interquartile range) displacement force needed to extract grafts anchored by stent A was 2.5 N (2.0 to 3.4), stent B 7.8 N (7.4 to 10.8), and stent C 22.5 N (17.1 to 27.9), p barbs added anchoring strength. During traction, the weaker barbs were distorted or caused intimal tears. The stronger barbs engaged the entire aortic wall. The radial force of the stents had no impact on fixation, while aortic calcification and graft oversizing had marginal effects. Stent barbs and hooks increased the fixation of stent-grafts tenfold, while the radial force of stents had no impact. These data may prove important in future endograft development to prevent stent-graft migration after aneurysm exclusion.

  20. Predictive Factors of In-Stent Restenosis in Renal Artery Stenting: A Retrospective Analysis

    International Nuclear Information System (INIS)

    Vignali, Claudio; Bargellini, Irene; Lazzereschi, Michele; Cioni, Roberto; Petruzzi, Pasquale; Caramella, Davide; Pinto, Stefania; Napoli, Vinicio; Zampa, Virna; Bartolozzi, Carlo

    2005-01-01

    Purpose. To retrospectively evaluate the role of clinical and procedural factors in predicting in-stent restenosis in patients with renovascular disease treated by renal artery stenting. Methods. From 1995 to 2002, 147 patients underwent renal artery stenting for the treatment of significant ostial atherosclerotic stenosis. Patients underwent strict clinical and color-coded duplex ultrasound follow-up. Ninety-nine patients (111 stents), with over 6 months of continuous follow-up (mean 22±12 months, range 6-60 months), were selected and classified according to the presence (group A, 30 patients, 32 lesions) or absence (group B, 69 patients, 79 lesions) of significant in-stent restenosis. A statistical analysis was performed to identify possible preprocedural and procedural predictors of restenosis considering the following data: sex, age, smoking habit, diabetes mellitus, hypertension, serum creatinine, cholesterol and triglyceride levels, renal artery stenosis grade, and stent type, length and diameter. Results. Comparing group A and B patients (χ 2 test), a statistically significant relation was demonstrated between stent diameter and length and restenosis: the risk of in-stent restenosis decreased when the stent was ≥6 mm in diameter and between 15 and 20 mm in length. This finding was confirmed by multiple logistic regression analysis. Stent diameter and length were proved to be significantly related to in-stent restenosis also when evaluating only patients treated by Palmaz stent (71 stents). Conclusion. Although it is based on a retrospective analysis, the present study confirms the importance of correct stent selection in increasing long-term patency, using stents of at least 6 mm in diameter and with a length of approximately 15-20 mm

  1. Delayed cerebral infarction due to stent folding deformation following carotid artery stenting

    Energy Technology Data Exchange (ETDEWEB)

    Seo, Kwon Duk; Lee, Kyung Yul; Suh, Sang Hyun [Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); Kim, Byung Moon [Dept. of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2014-12-15

    We report a case of delayed cerebral infarction due to stent longitudinal folding deformation following carotid artery stenting using a self-expandable stent with an open-cell design. The stented segment of the left common carotid artery was divided into two different lumens by this folding deformation, and the separated lumens became restricted with in-stent thrombosis. Although no established method of managing this rare complication exists, a conservative approach was taken with administration of anticoagulant and dual antiplatelet therapy. No neurological symptoms were observed during several months of clinical follow-up after discharge.

  2. A newly-designed temporary cardia stent for the treatment of achalasia:an experimental study in canine models

    International Nuclear Information System (INIS)

    Kuang Xiaochun; Cheng Yingsheng; Zhu Yueqi; Li Feng; Wang Weiguo

    2010-01-01

    Objective: To assess the efficacy and safety of a newly-designed temporary covered cardia stent for the treatment of achalasia in canine models and to investigate the histopathological changes at different points of follow-up time after the stent was removed. Methods: The canine achalasia model was created by injecting benzyl-dimethyl-tetradecyl ammonium chloride (BAC) circumferentially into the lower esophageal sphincter (LES) of the dogs. Twenty-four dogs with achalasia were randomly and equally divided into two groups with 12 dogs in each group: control group (using routine esophageal stents) and study group (using newly-designed temporary covered cardia stents). Under fluoroscopic guidance stents were implanted in the esophagus and were taken away from the esophagus 4 days after stent insertion in experimental dogs of both groups. LES pressures and timed barium esophagography (TBE) were performed in all dogs before and immediately after the stenting procedure, as well as at one week, 3 and 6 months after the stent was removed. Every three dogs were sacrificed each time at one week, 3 and 6 months after the stent was removed. The esophageal cardia was excised and sent for pathological examination. Results: All animals well tolerated the stent insertion / removal and the follow-up procedures. No severe complications such as esophageal perforation occurred. Comparison between two groups showed that stent migration occurrence was much lower in study group (n = 1) than that in control group (n = 5). The reduction of LES pressures in study group was more significant in comparison with control group (at 6-month follow-up, P = 0.027). The difference in barium column product (height x width) between 0-min and 5-min TBE was statistically significant in study group (at 3-month follow-up, P = 0.009). Integrated analysis of multi-comparison for LES pressures among subgroups of each group revealed that the dogs in study group exhibited better outcomes than the dogs in

  3. The effect of stent coating on stent deliverability: direct randomised comparison of drug eluting and bare metal stents using the same stent platform.

    Science.gov (United States)

    Siminiak, Tomasz; Link, Rafał; Wołoszyn, Maciej; Kałmucki, Piotr; Baszko, Artur

    2012-01-01

    There is certain experimental and clinical evidence indicating that the covering of bare metal stents (BMS) with drug eluting polymers to produce drug eluting stents (DES) results in increased stent stiffness and modifies the mechanical properties of the stent platform. In addition, it has been speculated that the mechanical performance of DES, compared to BMS, may be related to the type of polymer used to cover stents. We aimed at evaluating the deliverability of DES with a lactate based biodegradable polymer and BMS in patients with stable coronary artery disease in a prospective randomised study. One hundred eleven consecutive patients (age: 36-77, mean 58.8 years) scheduled for routine angioplasty due to stable coronary disease were randomised to receive BMS (Chopin II(TM), Balton, Poland) or paclitaxel eluting stent (Chopin Luc(TM), Balton, Poland) using the same metal platform. Only patients scheduled for angioplasty using the direct implantation technique of a single stent were randomised. The exclusion criteria included patients 〉 80 years, multivessel disease and reference diameter of the target vessel 〉 3.5 mm. In the BMS group (n = 55; 35 males and 20 females), the mean diameter of implanted stents was 3.09 ± 0.40 and the mean length was 11.37 ± 2.80, whereas in the DES group (n = 56; 34 males and 22 females) the mean stent sizes were 3.02 ± 0.34 and 17.90 ± 7.38 mm, respectively (p 〉 0.05 for length). The groups did not significantly differ regarding the frequency of stent implantation to particular coronary vessels. The direct stenting technique was attempted and failed, leading to the stents' implantation after predilatation in five patients in the BMS group and six patients in the DES group. Failure of stent implantation and subsequent implantation of another stent type was observed in no BMS patients and in one DES patient (NS). Although stent covering with lactate based drug eluting polymer may increase its stiffness, it does not affect

  4. Iliocaval Confluence Stenting for Chronic Venous Obstructions

    Energy Technology Data Exchange (ETDEWEB)

    Graaf, Rick de, E-mail: r.de.graaf@mumc.nl [Maastricht University Medical Centre (MUMC), Department of Radiology (Netherlands); Wolf, Mark de, E-mail: markthewolf@gmail.com [Maastricht University Medical Centre (MUMC), Department of Surgery (Netherlands); Sailer, Anna M., E-mail: anni.sailer@mumc.nl [Maastricht University Medical Centre (MUMC), Department of Radiology (Netherlands); Laanen, Jorinde van, E-mail: jorinde.van.laanen@mumc.nl; Wittens, Cees, E-mail: c.wittens@me.com [Maastricht University Medical Centre (MUMC), Department of Surgery (Netherlands); Jalaie, Houman, E-mail: hjalaie@ukaachen.de [University Hospital Aachen, Department of Surgery (Germany)

    2015-10-15

    PurposeDifferent techniques have been described for stenting of venous obstructions. We report our experience with two different confluence stenting techniques to treat chronic bi-iliocaval obstructions.Materials and MethodsBetween 11/2009 and 08/2014 we treated 40 patients for chronic total bi-iliocaval obstructions. Pre-operative magnetic resonance venography showed bilateral extensive post-thrombotic scarring in common and external iliac veins as well as obstruction of the inferior vena cava (IVC). Stenting of the IVC was performed with large self-expandable stents down to the level of the iliocaval confluence. To bridge the confluence, either self-expandable stents were placed inside the IVC stent (24 patients, SECS group) or high radial force balloon-expandable stents were placed at the same level (16 patients, BECS group). In both cases, bilateral iliac extensions were performed using nitinol stents.ResultsRecanalization was achieved for all patients. In 15 (38 %) patients, a hybrid procedure with endophlebectomy and arteriovenous fistula creation needed to be performed because of significant involvement of inflow vessels below the inguinal ligament. Mean follow-up was 443 ± 438 days (range 7–1683 days). For all patients, primary, assisted-primary, and secondary patency rate at 36 months were 70, 73, and 78 %, respectively. Twelve-month patency rates in the SECS group were 85, 85, and 95 % for primary, assisted-primary, and secondary patency. In the BECS group, primary patency was 100 % during a mean follow-up period of 134 ± 118 (range 29–337) days.ConclusionStenting of chronic bi-iliocaval obstruction shows relatively high patency rates at medium follow-up. Short-term patency seems to favor confluence stenting with balloon-expandable stents.

  5. The forgotten ureteric JJ stent and its prevention: a prospective audit of the value of a ureteric stent logbook.

    Science.gov (United States)

    Thomas, A Z; Casey, R G; Grainger, R; McDermott, T; Flynn, R; Thornhill, J A

    2007-01-01

    Temporary ureteric stent insertion is an integral part of modern endo-urological practice. Delayed stent removal or forgotten stents are associated with increased patient morbidity and complications which are often difficult to manage. We prospectively audited our ureteric stent insertion and removal logbook system to determine the value and effectiveness of our stent follow-up. Over a 1-year period, 210 ureteric stents were inserted in our urological unit. Of these, 47 (22.4%) patients were unaccounted as having their stents removed within the stent logbooks. One patient was lost to follow-up and re-presented with stent encrustation 10 months later. Our results in this audit suggest that our system of ureteric stent follow-up is not effective. We have now introduced a new system that we feel is a safer and a satisfactory alternative to the stent logbooks. This includes a patient education leaflet and removal date scheduling prior to discharge from hospital.

  6. [The Predictive Factors of Stent Failure in the Treatment of Malignant Extrinsc Ureteral Obstruction Using Internal Ureteral Stents].

    Science.gov (United States)

    Matsuura, Hiroshi; Arase, Shigeki; Hori, Yasuhide; Tochigi, Hiromi

    2017-12-01

    In this study, we retrospectively reviewed the experiences at our single institute in the treatment of malignant extrinsic ureteral obstruction (MUO) using ureteral stents to investigate the clinical outcomes and the predictive factors of stent failure. In 52 ureters of 38 patients who had radiologically significant hydronephrosis due to MUO, internal ureteral stents (The BARD(R) INLAY(TM) ureteral stent set) were inserted. The median follow-up interval after the initial stent insertion was 124.5 days (4-1,120). Stent failure occurred in 8 ureters (15.4%) of the 7 patients. The median interval from the first stent insertion to stent failure was 88 days (1-468). A Cox regression multivariate analysis showed that the significant predictors of stent failure were bladder invasion. Based on the possibility of stent failure, the adaptation of the internal ureteral stent placement should be considered especially in a patient with MUO combined with bladder invasion.

  7. MRT of carotid stents: influence of stent properties and sequence parameters on visualization of the carotid artery lumen

    International Nuclear Information System (INIS)

    Straube, T.; Wolf, S.; Alfke, K.; Jansen, O.; Flesser, A.; Deli, M.; Nabavi, A.

    2005-01-01

    Purpose: To evaluate MR artifacts of carotid artery stents and to optimize stent properties and sequence parameters. Material and Methods: Four carotid artery stents - Wallstent (mediloy), Precise (nitinol), ACCULINK (nitinol) and a stent prototype (nitinol) - were investigated in a flow model of the cervical vessels. The model was made of silicon tubing and a flow pump that produces realistic flow curves of the carotid artery. To investigate the effects of magnetic susceptibility and radiofrequency induced shielding artifacts, turbo spin echo and gradient echo sequences as well as CE-MRAs were measured. To improve the visualization of the stent lumen in a CE-MRA, flip angle as well as geometry and covering of the stent prototype were altered. Results: Susceptibility artifacts in stents of the carotid artery only influence the lumen visualization at the proximal and distal end of the braided mediloy stent. A change of stent coverings has no significant influence on radiofrequency artifacts, whereas a reduction in linking elements between stent segments and a change in diameter of stent struts improves visualization of the stent lumen. By increasing the flip angle in a CE-MRA, visualization of the stent lumen is possible in both mediloy and nitinol stents. Conclusion: The choice of stent material and changes in stent geometry as well as the optimization of the flip angle of the CE-MRA may reduce susceptibility and radiofrequency artifacts, rendering feasible the CE-MRA of a stented carotid artery. (orig.)

  8. Compliance Study of Endovascular Stent Grafts Incorporated with Polyester and Polyurethane Graft Materials in both Stented and Unstented Zones

    Directory of Open Access Journals (Sweden)

    Ying Guan

    2016-08-01

    Full Text Available Compliance mismatch between stent graft and host artery may induce complications and blood flow disorders. However, few studies have been reported on stent graft compliance. This study aims to explore the deformation and compliance of stent graft in stented and unstented zones under three pressure ranges. Compliance of two stent grafts incorporated with polyurethane graft (nitinol-PU and polyester graft (nitinol-PET materials respectively were tested; the stents used in the two stent grafts were identical. For the circumferential deformation of the stent grafts under each pressure range, the nitinol-PET stent graft was uniform in both zones. The nitinol-PU stent graft was circumferentially uniform in the stented zone, however, it was nonuniform in the unstented zone. The compliance of the PU graft material was 15 times higher than that of the PET graft. No significant difference in compliance was observed between stented and unstented zones of the nitinol-PET stent graft regardless of the applied pressure range. However, for the nitinol-PU stent graft, compliance of the unstented PU region was approximately twice that of the stented region; thus, compliance along the length of the nitinol-PU stent graft was not constant and different from that of the nitinol-PET stent graft.

  9. Endoscopic Biliary Stenting Versus Percutaneous Transhepatic Biliary Stenting in Advanced Malignant Biliary Obstruction: Cost-effectiveness Analysis.

    Science.gov (United States)

    Sun, Xin Rong; Tang, Cheng Wu; Lu, Wen Ming; Xu, Yong Qiang; Feng, Wen Ming; Bao, Yin; Zheng, Yin Yuan

    2014-05-01

    This study aims to compare the clinical outcomes and costs between endoscopic biliary stenting (EBS) and percutaneous transhepatic biliary stenting (PTBS). We randomly assigned 112 patients with unresectable malignant biliary obstruction 2006 and 2011 to receive EBS or PTBS with self-expandable metal stent (SEMS) as palliative treatment. PTBS was successfully performed in 55 patients who formed the PTBS group (failed in 2 patients). EBS was successfully performed in 52 patients who formed the EBS group (failed in 3 patients). The effectiveness of biliary drainage, hospital stay, complications, cost, survival time and mortality were compared. Patients in PTBS group had shorter hospital stay and lower initial and overall expense than the BBS group (P PTBS group was significantly lower than in EBS group (3/55 vs 11/52, P = 0.0343). Late complications in the EBS group did not differ significantly from PTBS group (7/55 vs 9/52, P = 0.6922). The survival curves in the two groups showed no significant difference (P = 0.5294). Conclusions: 3.

  10. Risk Factors and Clinical Evaluation of Superficial Femoral Artery Stent Fracture: Prote'ge'GPS Stent

    International Nuclear Information System (INIS)

    Lee, Da Un; Kim, Jae Kyu; Jung, Hye Doo; Huh, Tae Wook; Yim, Nam Yeol; Oh, Hyun jun; Choi, Soo Jin Na; Chang, Nam Kyu

    2010-01-01

    To evaluate the occurrence of superficial femoral artery stent fractures, the risk factors of stent fracture, and the relationship between fractures and clinical findings. Of the 38 patients who underwent treatment with Prote'ge'GPS stenting due to arterial occlusions on the superficial femoral artery, 17 also underwent a clinical analysis. Forty-three stents were inserted in the 17 superficial femoral arteries, ranging between 15 and 50 cm in length, with a mean treated length of 26.4 cm (15-50 cm). A fracture was evaluated by taking a PA and lateral simple radiography, as well as a follow-up evaluation accompanied with a CT angiography, DSA, and a color Doppler sonography. The examination involved the assessment of the difference between bone fractures due to length, placement, and frequency. Fractures occurred in 13 of 43 stents (30.2%). A total of 10 (71.4%) occurred in the upper third, compared to 4 (28.6%) in the lower third of the superficial femoral artery. In addition, 10 stents (71.4%) had a single strut fracture, whereas 4 (28.6%) had multiple strut fractures. A stent fracture occurred more frequently when the stents and lesions were longer (p=0.021, 0.012) and the stents were inserted near the joint. However, there was no significant relationship between stent numbers and the fractures (p=0.126). When the stents were inserted along the popliteal artery, a stent fracture occurred more frequently in the lower third of the artery. The stent fractures did not significantly influence the patency rate of the stented artery (p=0.44) Prote'ge'GPS stents in the superficial femoral artery revealed a considerable number of fractures and the fracture frequency showed a significant relationship with the length of stents and lesions. The closer stent insertion was to the joints, the more frequently fractures occurred. There were no evident significant relationships between the presence of stent fractures and the patency of the stented arteries

  11. Similar five-year outcome with paclitaxel- and sirolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Bligaard, Niels; Thuesen, Leif; Saunamäki, Kari

    2014-01-01

    patients with ST-segment elevation myocardial infarction (STEMI), non-STEMI, stable or unstable angina pectoris were randomized to receive Cypher™ (n = 1.065) or Taxus™ (n = 1.033) stents and were followed for 5 years. RESULTS: The primary end-point; the composite of cardiac death, myocardial infarction...... and target vessel revascularization (major adverse cardiac event, MACE), occurred in 467 patients (22.3%); Cypher™ n = 222 (20.8%), Taxus™ n = 245 (23.7%), ns. Definite and probable stent thrombosis occurred in 107 patients (5.1%); Cypher™ n = 51 (4.8%), Taxus™ n = 56 (5.4%), ns. No statistically significant...

  12. Feasibility study using a Ni-Ti stent and electronic portal imaging to localize the prostate during radiotherapy

    International Nuclear Information System (INIS)

    Carl, Jesper; Lund, Bente; Larsen, Erik Hoejkjaer; Nielsen, Jane

    2006-01-01

    Background and purpose: A new method for localization of the prostate during external beam radiotherapy is presented. The method is based on insertion of a thermo-expandable Ni-Ti stent. The stent is originally developed for treatment of bladder outlet obstruction caused by benign hyperplasia. The radiological properties of the stent are used for precise prostate localization during treatment using electronic portal images. Patients and methods: Patients referred for intended curative radiotherapy and having a length of their prostatic urethra in the range from 25 to 65 mm were included. Pairs of isocentric orthogonal portal images were used to determine the 3D position at eight different treatment sessions for each patient. Results: Fourteen patients were enrolled in the study. The data obtained demonstrated that the stent position was representative of the prostate location. The stent may also improve delineation of the prostate GTV, and prevent obstruction of bladder outlet during treatment. Precision in localization of the stent was less than 1 mm. Random errors in stent position were left-right 1.6 mm, cranial-caudal 2.2 mm and anterior-posterior 3.2 mm. In four of 14 patients a dislocation of the stent to the bladder occurred. Dislocation only occurred in patients with length of prostatic urethra less than 40 mm. Conclusions: A new method for radiological high precision localization of the prostate during radiotherapy is presented. The method is based on insertion of a standard Ni-Ti thermo-expandable stent, designed for treatment of benign prostate hyperplasia

  13. Stent placement for esophageal strictures : an update

    NARCIS (Netherlands)

    Hirdes, Meike Madeleine Catharine; Vleggaar, Frank Paul; Siersema, Peter Derk

    The use of stents for esophageal strictures has evolved rapidly over the past 10 years, from rigid plastic tubes to flexible self-expanding metal (SEMS), plastic (SEPS) and biodegradable stents. For the palliative treatment of malignant dysphagia both SEMS and SEPS effectively provide a rapid relief

  14. Stent migration following endoscopic suture fixation of esophageal self-expandable metal stents: a systematic review and meta-analysis.

    Science.gov (United States)

    Law, Ryan; Prabhu, Anoop; Fujii-Lau, Larissa; Shannon, Carol; Singh, Siddharth

    2018-02-01

    Covered self-expandable metal stents (SEMS) are utilized for the management of benign and malignant esophageal conditions; however, covered SEMS are prone to migration. Endoscopic suture fixation may mitigate the migration risk of covered esophageal SEMS. Hence, we conducted a systematic review and meta-analysis to evaluate the effectiveness and safety of endoscopic suture fixation for covered esophageal SEMS. Following PRISMA guidelines, we performed a systematic review from 2011 to 2016 to identify studies (case control/case series) reporting the technical success and migration rate of covered esophageal SEMS following endoscopic suture fixation. We searched multiple electronic databases and conference proceedings. We calculated pooled rates (and 95% confidence intervals [CI]) of technical success and stent migration using a random effects model. We identified 14 studies (212 patients) describing covered esophageal SEMS placement with endoscopic suture fixation. When reported, SEMS indications included leak/fistula (n = 75), stricture (n = 65), perforation (n = 10), and achalasia (n = 4). The pooled technical success rate was 96.7% (95% CI 92.3-98.6), without heterogeneity (I 2  = 0%). We identified 29 SEMS migrations at rate of 15.9% (95% CI 11.4-21.6), without heterogeneity (I 2  = 0%). Publication bias was observed, and using the trim-and-fill method, a more conservative estimate for stent migration was 17.0%. Suture-related adverse events were estimated to occur in 3.7% (95% CI 1.6-8.2) of cases. Endoscopic suture fixation of covered esophageal SEMS appears to reduce stent migration when compared to published rates of non-anchored SEMS. However, SEMS migration still occurs in approximately 1 out of 6 cases despite excellent immediate technical success and low risk of suture-related adverse events.

  15. Esophageal Stent for Refractory Variceal Bleeding: A Systemic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Xiao-Dong Shao

    2016-01-01

    Full Text Available Background. Preliminary studies suggest that covered self-expandable metal stents may be helpful in controlling esophageal variceal bleeding. Aims. To evaluate the effectiveness and safety of esophageal stent in refractory variceal bleeding in a systematic review and meta-analysis. Methods. A comprehensive literature search was conducted on PubMed, EMBASE, and Cochrane Library covering the period from January 1970 to December 2015. Data were selected and abstracted from eligible studies and were pooled using a random-effects model. Heterogeneity was assessed using I2 test. Results. Five studies involving 80 patients were included in the analysis. The age of patients ranged from 18 to 91 years. The mean duration of follow-up was 46.8 d (range, 30–60 d. The success rate of stent deployment was 96.7% (95% CI: 91.6%–99.5% and complete response to esophageal stenting was in 93.9% (95% CI: 82.2%–99.6%. The incidence of rebleeding was 13.2% (95% CI: 1.8%–32.8% and the overall mortality was 34.5% (95% CI: 24.8%–44.8%. Most of patients (87.4% died from hepatic or multiple organ failure, and only 12.6% of patients died from uncontrolled bleeding. There was no stent-related complication reported and the incidence of stent migration was 21.6% (95% CI: 4.7%–46.1%. Conclusion. Esophageal stent may be considered in patients with variceal bleeding refractory to conventional therapy.

  16. Incidence of definite stent thrombosis or in-stent restenosis after drug-eluting stent implantation for treatment of coronary in-stent restenosis. From western denmark heart registry

    DEFF Research Database (Denmark)

    Jensen, Jesper; Jensen, Lisette Okkels; Terkelsen, Christian Juhl

    2012-01-01

    There are limited data on the optimal management of in-stent restenosis after percutaneous coronary intervention (PCI) with bare metal stent (BMS) or drug-eluting stent (DES) implantations. We assessed the clinical presentation, the incidence, and prognosis of definite stent thrombosis...

  17. Stent Graft in Managing Juxta-Renal Aortoiliac Occlusion

    International Nuclear Information System (INIS)

    Prabhudesai, V.; Mitra, K.; West, D. J.; Dean, M. R. E.

    2003-01-01

    Endovascular procedures are frequently used as an alternative to surgical bypass in aortic and iliac occlusion. Stents have revolutionized the scope of such endovascular procedures, but there are few reports of stents or stent grafts in occlusive juxta-renal aortic occlusion. We present a case where such occlusion was managed by use of a stent graft with successful outcome

  18. Basic Knowledge about Metal Stent Development

    Directory of Open Access Journals (Sweden)

    Seok Jeong

    2016-03-01

    Full Text Available Biliary self-expandable metal stents (SEMS, a group of non-vascular stents, have been used in the palliative management of biliary obstruction around the world. However, there are still unmet needs in the clinical application of biliary SEMS. Comprehensive understanding of the SEMS is required to resolve the drawbacks and difficulties of metal stent development. The basic structure of SEMS, including the materials and knitting methods of metal wires, covering materials, and radiopaque markers, are discussed in this review. What we know about the physical and mechanical properties of the SEMS is very important. With an understanding of the basic knowledge of metal stents, hurdles such as stent occlusion, migration, and kinking can be overcome to develop more ideal SEMS.

  19. Stent graft placement for dysfunctional arteriovenous grafts

    Energy Technology Data Exchange (ETDEWEB)

    Jeon, Gyeong Sik [Dept. of Radiology, CHA Bundang Medical Center, College of Medicine, CHA University, Seongnam (Korea, Republic of); Shin, Byung Seok; Ohm, Joon Young; Ahn, Moon Sang [Chungnam National University Hospital, Daejeon (Korea, Republic of)

    2015-07-15

    This study aimed to evaluate the usefulness and outcomes of stent graft use in dysfunctional arteriovenous grafts. Eleven patients who underwent stent graft placement for a dysfunctional hemodialysis graft were included in this retrospective study. Expanded polytetrafluoroethylene covered stent grafts were placed at the venous anastomosis site in case of pseudoaneurysm, venous laceration, elastic recoil or residual restenosis despite the repeated angioplasty. The patency of the arteriovenous graft was evaluated using Kaplan-Meier analysis. Primary and secondary mean patency was 363 days and 741 days. Primary patency at 3, 6, and 12 months was 82%, 73%, and 32%, respectively. Secondary patency at the 3, 6, 12, 24, and 36 months was improved to 91%, 82%, 82%, 50%, and 25%, respectively. Fractures of the stent graft were observed in 2 patients, but had no effect on the patency. Stent graft placement in dysfunctional arteriovenous graft is useful and effective in prolonging graft patency.

  20. External stent for repair of secondary tracheomalacia.

    Science.gov (United States)

    Johnston, M R; Loeber, N; Hillyer, P; Stephenson, L W; Edmunds, L H

    1980-09-01

    Tracheomalacia was created in anesthetized piglets by submucosal resection of 3 to 5 tracheal cartilages. Measurements of airway pressure and flow showed that expiratory airway resistance is maximal at low lung volumes and is significantly increased by creation of the malacic segment. Cervical flexion increases expiratory airway resistance, whereas hyperextension of the neck reduces resistance toward normal. External stenting of the malacic segment reduces expiratory airway resistance, and the combination of external stenting and hyperextension restores airway resistance to normal except at low lung volume. Two patients with secondary tracheomalacia required tracheostomy and could not be decannulated after the indication for the tracheostomy was corrected. Both were successfully decannulated after external stenting of the malacic segment with rib grafts. Postoperative measurements of expiratory pulmonary resistance show a marked decrease from preoperative measurements. External stenting of symptomatic tracheomalacia reduces expiratory airway resistance by supporting and stretching the malacic segment and is preferable to prolonged internal stenting or tracheal resection.

  1. Atrial septal stenting - How I do it?

    Directory of Open Access Journals (Sweden)

    Kothandam Sivakumar

    2015-01-01

    Full Text Available A wide atrial communication is important to maintain hemodynamics in certain forms of congenital and acquired heart defects. In comparison to balloon septostomy or blade septostomy, atrial septal stenting provides a controlled, predictable, and long-lasting atrial communication. It often needs a prior Brockenbrough needle septal puncture to obtain a stable stent position. A stent deployed across a previously dilated and stretched oval foramen or tunnel form of oval foramen carries higher risk of embolization. This review provides technical tips to achieve a safe atrial septal stenting. Even though this is a "How to do it article," an initial discussion about the indications for atrial septal stenting is vital as the resultant size of the atrial septal communication should be tailored for each indication.

  2. Classic crush and DK crush stenting techniques.

    Science.gov (United States)

    Zhang, Jun-Jie; Chen, Shao-Liang

    2015-01-01

    Clinical data have supported the advantages of the double kissing (DK) crush technique, which consists of stenting the side branch (SB), balloon crush, first kissing, stenting the main vessel (MV) and final kissing balloon inflation, for complex coronary bifurcation lesions compared to other stenting techniques. Careful rewiring from the proximal cell of the MV stent to make sure the wire is in the true lumen of the SB stent is key to acquiring optimal angiographic results. Balloon anchoring from the MV, alternative inflation and each kissing inflation using large enough non-compliant balloons at high pressure, and the proximal optimisation technique are mandatory to improve both angiographic and clinical outcomes. Stratification of a given bifurcation lesion is recommended before decision making.

  3. Plastic Biliary Stent Migration During Multiple Stents Placement and Successful Endoscopic Removal Using Intra-Stent Balloon Inflation Technique: A Case Report and Literature Review.

    Science.gov (United States)

    Calcara, Calcedonio; Broglia, Laura; Comi, Giovanni; Balzarini, Marco

    2016-02-05

    Late migration of a plastic biliary stent after endoscopic placement is a well known complication, but there is little information regarding migration of a plastic stent during multiple stents placement. A white man was hospitalized for severe jaundice due to neoplastic hilar stenosis. Surgical eligibility appeared unclear on admission and endoscopy was carried out, but the first stent migrated proximally at the time of second stent insertion. After failed attempts with various devices, the migrated stent was removed successfully through cannulation with a dilation balloon. The migration of a plastic biliary stent during multiple stents placement is a possible complication. In this context, extraction can be very complicated. In our patient, cannulation of a stent with a dilation balloon was the only effective method.

  4. Upper Gastrointestinal Stent Insertion in Malignant and Benign Disorders

    Science.gov (United States)

    Kang, Hyoun Woo

    2015-01-01

    Upper gastrointestinal (GI) stents are increasingly being used to manage upper GI obstructions. Initially developed for palliative treatment of esophageal cancer, upper GI stents now play an emerging role in benign strictures of the upper GI tract. Because recurrent obstruction and stent-related complications are common, new modifications of stents have been implemented. Self-expandable metal stents (SEMS) have replaced older plastic stents. In addition, newly designed SEMS have been developed to prevent complications. This review provides an overview of the various types, indications, methods, complications, and clinical outcomes of upper GI stents in a number of malignant and benign disorders dividing the esophagus and gastroduodenum. PMID:26064817

  5. Incidence of New Ischaemic Brain Lesions After Carotid Artery Stenting with the Micromesh Roadsaver Carotid Artery Stent: A Prospective Single-Centre Study

    Energy Technology Data Exchange (ETDEWEB)

    Ruffino, Maria Antonella, E-mail: mruffino@cittadellasalute.to.it [Azienda Ospedaliera Universitaria- Città della Salute e della Scienza di Torino, San Giovanni Battista Hospital, Vascular Radiology Unit, Department of Diagnostic Imaging and Radiotherapy (Italy); Faletti, Riccardo [University of Torino, Azienda Ospedaliera Universitaria- Città della Salute e della Scienza di Torino, San Giovanni Battista Hospital, Radiology Unit, Department of Surgical Sciences (Italy); Bergamasco, Laura [University of Torino, Azienda Ospedaliera Universitaria- Città della Salute e della Scienza di Torino, San Giovanni Battista Hospital, Department of Surgical Sciences (Italy); Fonio, Paolo [University of Torino, Azienda Ospedaliera Universitaria- Città della Salute e della Scienza di Torino, San Giovanni Battista Hospital, Radiology Unit, Department of Surgical Sciences (Italy); Righi, Dorico [Azienda Ospedaliera Universitaria- Città della Salute e della Scienza di Torino, San Giovanni Battista Hospital, Vascular Radiology Unit, Department of Diagnostic Imaging and Radiotherapy (Italy)

    2016-11-15

    AimsSeveral randomized trials of patients with carotid stenosis show increased adverse neurological events with stenting versus endarterectomy in the 30-day post-procedure. This study examines the incidence of new ischaemic lesions in patients treated in our centre using the new Roadsaver stent.Methods and resultsBetween September 2015 and January 2016, 23 consecutive patients (age 74.3 ± 7.3 years, 17.4 % female) underwent carotid artery stenting with the Roadsaver stent, a nitinol double-layer micromesh device. A distal protection device was used in all cases. Diffusion-weighted magnetic resonance imaging was performed 24 h before, and 24 h and 30 days after the procedure. The 24-h post-procedure imaging showed 15 new ipsilateral ischaemic lesions in 7 (30.4 %) patients: median volume 0.076 cm{sup 3} (interquartile range 0.065–0.146 cm{sup 3}). All lesions were asymptomatic. The 30-day imaging showed complete resolution of all lesions and no new ischaemic lesions. Follow-up clinical and ultrasound examinations at 30 days and 6 months recorded no adverse cardiac or cerebrovascular events.ConclusionsProtected stenting with micromesh Roadsaver stent showed good safety and efficacy in the treatment of carotid stenosis, with a low incidence of delayed embolic events and new ipsilateral ischaemic brain lesions. These preliminary results are encouraging, but need to be confirmed with larger populations.

  6. Incidence of New Ischaemic Brain Lesions After Carotid Artery Stenting with the Micromesh Roadsaver Carotid Artery Stent: A Prospective Single-Centre Study

    International Nuclear Information System (INIS)

    Ruffino, Maria Antonella; Faletti, Riccardo; Bergamasco, Laura; Fonio, Paolo; Righi, Dorico

    2016-01-01

    AimsSeveral randomized trials of patients with carotid stenosis show increased adverse neurological events with stenting versus endarterectomy in the 30-day post-procedure. This study examines the incidence of new ischaemic lesions in patients treated in our centre using the new Roadsaver stent.Methods and resultsBetween September 2015 and January 2016, 23 consecutive patients (age 74.3 ± 7.3 years, 17.4 % female) underwent carotid artery stenting with the Roadsaver stent, a nitinol double-layer micromesh device. A distal protection device was used in all cases. Diffusion-weighted magnetic resonance imaging was performed 24 h before, and 24 h and 30 days after the procedure. The 24-h post-procedure imaging showed 15 new ipsilateral ischaemic lesions in 7 (30.4 %) patients: median volume 0.076 cm"3 (interquartile range 0.065–0.146 cm"3). All lesions were asymptomatic. The 30-day imaging showed complete resolution of all lesions and no new ischaemic lesions. Follow-up clinical and ultrasound examinations at 30 days and 6 months recorded no adverse cardiac or cerebrovascular events.ConclusionsProtected stenting with micromesh Roadsaver stent showed good safety and efficacy in the treatment of carotid stenosis, with a low incidence of delayed embolic events and new ipsilateral ischaemic brain lesions. These preliminary results are encouraging, but need to be confirmed with larger populations.

  7. An ovine in vivo framework for tracheobronchial stent analysis.

    Science.gov (United States)

    McGrath, Donnacha J; Thiebes, Anja Lena; Cornelissen, Christian G; O'Shea, Mary B; O'Brien, Barry; Jockenhoevel, Stefan; Bruzzi, Mark; McHugh, Peter E

    2017-10-01

    Tracheobronchial stents are most commonly used to restore patency to airways stenosed by tumour growth. Currently all tracheobronchial stents are associated with complications such as stent migration, granulation tissue formation, mucous plugging and stent strut fracture. The present work develops a computational framework to evaluate tracheobronchial stent designs in vivo. Pressurised computed tomography is used to create a biomechanical lung model which takes into account the in vivo stress state, global lung deformation and local loading from pressure variation. Stent interaction with the airway is then evaluated for a number of loading conditions including normal breathing, coughing and ventilation. Results of the analysis indicate that three of the major complications associated with tracheobronchial stents can potentially be analysed with this framework, which can be readily applied to the human case. Airway deformation caused by lung motion is shown to have a significant effect on stent mechanical performance, including implications for stent migration, granulation formation and stent fracture.

  8. Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

    Science.gov (United States)

    Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; Otaegui, Imanol; Masotti, Mónica; Zueco, Javier; Veláquez, Maite; Sanchís, Juan; García-Touchard, Arturo; Lázaro-García, Rosa; Moreu, José; Bethencourt, Armando; Cuesta, Javier; Rivero, Fernando; Cárdenas, Alberto; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Fernández, Cristina

    2016-06-27

    The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p 1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  9. Stent insertion in patients with malignant biliary obstruction: problems of the Hanaro stent

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Jae Hyun; Seong, Chang Kyu; Shin, Tae Beom; Kim, Yong Joo [School of Medicine, Kyungpook National Univ., Daegu (Korea, Republic of); Jung, Gyoo Sik [School of Medicine, Kosin National Univ., Pusan (Korea, Republic of); Park, Byeung Ho [School of Medicine, Donga National Univ., Pusan (Korea, Republic of)

    2002-07-01

    To investigate the problems of the Hanaro stent (Solco Intermed, Seoul, Korea) when used in the palliative treatment of patients with inoperable malignant biliary obstruction. Between January 2000 and May 2001, the treatment of 46 patients with malignant biliary obstruction involved percutaneous placement of the Hanaro stent. Five patients encountered problems during removal of the stent's introduction system. The causes of obstruction were pancreatic carcinoma (n=2), cholangiocarcinoma (n=2), and gastric carcinoma with biliary invasion (n=1). In one patient, percutaneous transhepatic cholangiography and stent insertion were performed as a one-step procedure, while the others underwent conventional percutaneous transhepatic biliary drainage for at least two days prior to stent insertion. A self-expandable Hanaro stent, 8-10 mm in deameter and 50-100 mm in lengh, and made from a strand of nitinol wire, was used in all cases. Among the five patients who encountered problems, breakage of the olive tip occourred in three, upward displacement of the stent in two, and improper expansion of the distal portion of the stent, unrelated with the obstruction site, in one. The broken olive tip was pushed to the duodenum in two cases and to the peripheral intrahepatic duct in one. Where the stent migrated during withdrawal of its introduction system, an additional stent was inserted. In one case, the migrated stent was positioned near the liver capsule and the drainage catheter could not be removed. Although the number of patients in this study was limited, some difficulties were encountered in withdrawing the stent's introduction system. To prevent the occurrence of this unusual complication, the stent should be appropriately expansile, and shape in the olive tip should be considered.

  10. Self-expandable metallic stents vs. plastic stents for endoscopic biliary drainage in hepatocellular carcinoma.

    Science.gov (United States)

    Chung, Kwang Hyun; Lee, Sang Hyub; Park, Jin Myung; Lee, Jae Min; Ahn, Dong-Won; Ryu, Ji Kon; Kim, Yong-Tae

    2015-06-01

    The patency of self-expandable metallic stents (SEMS) is known to be better than plastic stents in the palliation of malignant biliary obstruction. However, data are scarce for obstructive jaundice caused by hepatocellular carcinoma (HCC). This study aimed to compare SEMSs and plastic stents for the palliation of obstructive jaundice in unresectable HCC. A total of 96 patients who underwent endoscopic retrograde biliary drainage with SEMSs or plastic stents were included in this retrospective analysis. The rate of successful biliary drainage, adverse events, stent patency duration, and patient survival were compared between the SEMS (n = 36) and plastic stent (n = 60) groups. The rate of successful biliary drainage was similar between the SEMS and plastic stent groups (25/36 [69.4 %] vs. 39/60 [65.0 %]; P = 0.655). Adverse events occurred in 6 patients (16.7 %) in the SEMS group and 13 patients (21.7 %) in the plastic stent group (P = 0.552). The median patency duration was also similar between the two groups (60 vs. 68 days; P = 0.396). The median patient survival was longer in the plastic stent group than in the SEMS group (123 vs. 48 days; P = 0.005). SEMSs were not superior to plastic stents for the palliation of malignant biliary obstruction in HCC with regard to successful drainage, stent patency, and adverse events. Patient survival was better in the plastic stent group. Given the lower cost, plastic stents could be a favorable option for malignant biliary obstruction caused by HCC. © Georg Thieme Verlag KG Stuttgart · New York.

  11. Enterprise stent for the treatment of symptomatic intracranial atherosclerotic stenosis: an initial experience of 44 patients.

    Science.gov (United States)

    Feng, Zhengzhe; Duan, Guoli; Zhang, Ping; Chen, Lei; Xu, Yi; Hong, Bo; Zhao, Wenyuan; Liu, Jianmin; Huang, Qinghai

    2015-10-08

    Wingspan stenting for the treatment of complex intracranial atherosclerotic stenosis (ICAS), i.e., that involving tortuous vascular pathways, long (>15 mm) lesions or arterial bifurcations, has a relatively high risk of complications. This retrospective study assessed the safety and efficacy of undersized balloon angioplasty followed by deployment of the more flexible Enterprise stent for the treatment of complex symptomatic ICAS. Forty-four patients on combined antiplatelet therapy and intensive risk factor management and a symptomatic 70-99% stenosis of a major intracranial artery in complex settings that was treated with balloon angioplasty and Enterprise stent deployment between July 2009 and August 2013 were enrolled. Primary outcome was occurrence of ischemic or hemorrhagic stroke or death within 30 days after intervention. Secondary outcomes included procedural success (defined as achievement of 50% in-stent restenosis after mean 22 months follow-up. In this retrospective, single-center experience, undersized balloon angioplasty followed by Enterprise stent deployment appears technically feasible with a relatively low rate of complications for the treatment of complex symptomatic ICAS. Prospective, multicenter, randomized controlled trials against optimal medical management are warranted.

  12. A Novel Stent Coated with Antibodies to Endoglin Inhibits Neointimal Formation of Porcine Coronary Arteries

    Directory of Open Access Journals (Sweden)

    Song Cui

    2014-01-01

    Full Text Available Endoglin/CD105 is an accessory protein of the transforming growth factor-β receptor system that plays a critical role in proliferation of endothelial cells and neovasculature. Here, we aimed to assess the effect of novel stents coated with antibodies to endoglin (ENDs on coronary neointima formation. Thirty ENDs, thirty sirolimus-eluting stents (SESs, and thirty bare metal stents (BMSs were randomly assigned and placed in the coronary arteries in 30 juvenile pigs. Histomorphometric analysis and scanning electron microscopy were performed after stent implantation. Our results showed that after 7 days, there was no difference in the neointimal area and percent area stenosis in ENDs compared with SMSs or BMSs. After 14 days, the neointima area and percent area stenosis in ENDs were markedly decreased than those in BMSs or SESs (P<0.05. Moreover, the percentage of reendothelialization was significantly higher in ENDs than that in SESs or BMSs (P<0.01 at 7 and 14 days. The artery injury and the inflammation scores were similar in all groups at 7 and 14 days. In conclusion, our results demonstrated for the first time to our knowledge that endoglin antibody-coated stents can markedly reduce restenosis by enhancing reendothelialization in the porcine model and potentially offer a new approach to prevent restenosis.

  13. First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan - Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent.

    Science.gov (United States)

    Konishi, Akihide; Ho, Mami; Shirai, Yuko; Shirato, Haruki

    2018-05-25

    A prospective randomized clinical trial showed that the BioFreedom stent (Biosensors International), which is a polymer-free and carrier-free drug-coated stent, was significantly superior to a bare-metal stent (BMS) in patients at high bleeding risk who were receiving a 1-month course of dual antiplatelet therapy (DAPT). However, the stent thrombosis rate (2.01% for BioFreedom vs. 2.20% for BMS) was 4-6-fold higher than that of approved drug-eluting stents based on real-world data in Japan. Furthermore, the frequency of stent thrombosis at more than 1 month with the BioFreedom stent was slightly higher than that at less than 1 month. This result suggested that it would not be acceptable to stop DAPT universally at 1 month. Thus, the target patients for the BioFreedom stent are unspecified patients at high bleeding risk needing to continue DAPT for as long as necessary in Japan. Therefore, based on the pre- and post-marketing balance of medical devices regulations, regulatory approval was given for unspecified patients conditionally upon real-world data collection of 2,000 patients with a Use-Results Survey, instead of conducting additional pre-marketing clinical trial(s). The Use-Results Survey System is part of a strategy to expedite patients' access to innovative medical devices and to accelerate the development of medical devices.

  14. Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Grüntzig Lecture ESC 2014

    Science.gov (United States)

    Byrne, Robert A.; Joner, Michael; Kastrati, Adnan

    2015-01-01

    Modern-day stenting procedures leverage advances in pharmacotherapy and device innovation. Patients treated with contemporary antiplatelet agents, peri-procedural antithrombin therapy and new-generation drug-eluting stents (DES) have excellent outcomes over the short to medium term. Indeed, coupled with the reducing costs of these devices in most countries there remain very few indications where patients should be denied treatment with standard-of-care DES therapy. The two major causes of stent failure are stent thrombosis (ST) and in-stent restenosis (ISR). The incidence of both has reduced considerably in recent years. Current clinical registries and randomized trials with broad inclusion criteria show rates of ST at or stent failure neoatherosclerotic change within the stented segment represents a final common pathway for both thrombotic and restenotic events. In future, a better understanding of the pathogenesis of this process may translate into improved late outcomes. Moreover, the predominance of non-stent-related disease as a cause of subsequent myocardial infarction during follow-up highlights the importance of lifestyle and pharmacological interventions targeted at modification of the underlying disease process. Finally, although recent developments focus on strategies which circumvent the need for chronically indwelling stents—such as drug-coated balloons or fully bioresorbable stents—more data are needed before the wider use of these therapies can be advocated. PMID:26417060

  15. Biodegradable magnesium-alloy stent:current situation in research

    International Nuclear Information System (INIS)

    Chen Hua; Zhao Xianxian

    2011-01-01

    In recent years, permanent metal stents are employed in the majority of interventional therapies; nevertheless, such kind of stents carries the problems of thrombosis and restenosis. Therefore, the biodegradable magnesium alloy stent has become the focus of attention. Theoretically, it has overcome the problems caused by permanent metal stents, so it is the development direction to use the biodegradable magnesium alloy in future. The authors believe that biodegradable magnesium alloy stents will be widely used in interventional procedures for many diseases. (authors)

  16. Transient coronary aneurysm formation after Nevo™ stent implantation versus persistent coronary aneurysm after Cypher Select™ stent implantation

    DEFF Research Database (Denmark)

    Christiansen, Evald Høj; Lassen, Jens Flensted; Jensen, Lisette Okkels

    2011-01-01

    We implanted a Cypher Select™ coronary stent and two months later a Nevo™ sirolimus-eluting coronary stent in another vessel. At a prescheduled angiographic follow-up, coronary aneurysms were seen in the two stented segments, 6 and 8 months after stent implantation, respectively. Six months later......, the aneurysm had healed in the Nevo, but was still present in the Cypher stented segment. We hypothesize that aneurysm formation was induced by sirolimus and the polymer of the implanted stents, and that subsequent healing was possible in the Nevo stent after degradation of the polymer....

  17. Initial study of sediment antagonism and characteristics of silver nanoparticle-coated biliary stents in an experimental animal model

    Directory of Open Access Journals (Sweden)

    Tian Y

    2016-04-01

    Full Text Available Yigeng Tian,1,* Mingfeng Xia,2,* Shuai Zhang,3 Zhen Fu,4 Qingbin Wen,2 Feng Liu,4 Zongzhen Xu,4 Tao Li,4 Hu Tian4 1Department of Physics, School of Physics and Technology, University of Jinan, Jinan, Shandong, People’s Republic of China; 2Department of Surgery, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, People’s Republic of China; 3Department of General Surgery, Sixth People’s Hospital of Jinan, Jinan, Shandong, People’s Republic of China; 4Department of General Surgery, Shandong Provincial Qianfoshan Hospital, Shandong University, Jinan, Shandong, People’s Republic of China *These authors contributed equally to this work Objective: Plastic biliary stents used to relieve obstructive jaundice are frequently blocked by sediment, resulting in loss of drainage. We prepared stents coated with silver nanoparticles (AgNPs and compared their ability to resist sedimentation with Teflon stents in a beagle model of obstructive jaundice.Methods: AgNP-coated Teflon biliary stents were prepared by chemical oxidation–reduction and evaluated in an obstructive jaundice model that was produced by ligation of common bile duct (CBD; animals were randomized to two equal groups for placement of AgNP-coated or Teflon control stents. Liver function and inflammatory index were found to be similar in the two groups, and the obstruction was relieved. Stents were removed 21 days after insertion and observed by scanning and transmission electron microscopy. The AgNP coating was analyzed by energy dispersive X-ray analysis (EDXA, and the composition of sediment was assayed by Fourier-transform infrared (FTIR spectroscopy.Results: Electron microscopy revealed a black, closely adherent AgNP stent coating, with thicknesses of 1.5–6 µm. Sediment thickness and density were greater on Teflon than on AgNP-coated stents. EDXA confirmed the stability and integrity of the AgNP coating before and after in vivo animal experimentation. FTIR

  18. Antirestenotic Effects of a Novel Polymer-Coated D-24851 Eluting Stent. Experimental Data in a Rabbit Iliac Artery Model

    International Nuclear Information System (INIS)

    Lysitsas, Dimitrios N.; Katsouras, Christos S.; Papakostas, John C.; Toumpoulis, Ioannis K.; Angelidis, Charalampos; Bozidis, Petros; Thomas, Christopher G.; Seferiadis, Konstantin; Psychoyios, Nikolaos; Frillingos, Stathis; Pavlidis, Nikolaos; Marinos, Euaggelos; Khaldi, Lubna; Sideris, Dimitris A.; Michalis, Lampros K.

    2007-01-01

    Experimental and clinical data suggest that stents eluting antiproliferative agents can be used for the prevention of in-stent restenosis. Here we investigate in vitro the antiproliferative and apoptotic effect of D-24851 and evaluate the safety and efficacy of D-24851-eluting polymer-coated stents in a rabbit restenosis model (n = 53). Uncoated stents (n = 6), poly (dl-lactide-co-glycolide) (PLGA)-coated stents (n = 7), and PLGA-coated stents loaded with 0.08 ± 0.0025 μM (31 ± 1 μg; low dose; n = 7), 0.55 ± 0.02 μM (216 ± 8 μg; high dose; n = 6), and 4.55 ± 0.1 μM (1774 ± 39 μg; extreme dose; n = 5) of D-24851 were randomly implanted in New Zealand rabbit right iliac arteries and the animals were sacrificed after 28 days for histomorphometric analysis. For the assessment of endothelial regrowth in 90 days, 12 rabbits were subjected to PLGA-coated (n = 3), low-dose (n = 3), high-dose (n = 3), and extreme-dose (n = 3) stent implantation. In vitro studies revealed that D-24851 exerts its growth inhibitory effects via inhibition of proliferation and induction of apoptosis without increasing the expression of heat shock protein-70, a cytoprotective and antiapoptotic protein. Treatment with low-dose D-24851 stents was associated with a significant reduction in neointimal area and percentage stenosis only compared with bare metal stents (38% [P = 0.029] and 35% [P = 0.003] reduction, respectively). Suboptimal healing, however, was observed in all groups of D-24851-loaded stents in 90 days in comparison with PLGA-coated stents. We conclude that low-dose D-24851-eluting polymer-coated stents significantly inhibit neointimal hyperplasia at 28 days through inhibition of proliferation and enhancement of apoptosis. In view of the suboptimal re-endothelialization, longer-term studies are needed in order to establish whether the inhibition of intimal growth is maintained

  19. Complications of stent placement in patients with esophageal cancer: A systematic review and network meta-analysis.

    Directory of Open Access Journals (Sweden)

    Amin Doosti-Irani

    Full Text Available Palliative treatments and stents are necessary for relieving dysphagia in patients with esophageal cancer. The aim of this study was to simultaneously compare available treatments in terms of complications.Web of Science, Medline, Scopus, Cochrane Library and Embase were searched. Statistical heterogeneity was assessed using the Chi2 test and was quantified by I2. The results of this study were summarized in terms of Risk Ratio (RR. The random effects model was used to report the results. The rank probability for each treatment was calculated using the p-score.Out of 17855 references, 24 RCTs reported complications including treatment related death (TRD, bleeding, stent migration, aspiration, severe pain and fistula formation. In the ranking of treatments, thermal ablative therapy (p-score = 0.82, covered Evolution® stent (p-score = 0.70, brachytherapy (p-score = 0.72 and antireflux stent (p-score = 0.74 were better treatments in the network of TRD. Thermal ablative therapy (p-score = 0.86, the conventional stent (p-score = 0.62, covered Evolution® stent (p-score = 0.96 and brachytherapy (p-score = 0.82 were better treatments in the network of bleeding complications. Covered Evolution® (p-score = 0.78, uncovered (p-score = 0.88 and irradiation stents (p-score = 0.65 were better treatments in network of stent migration complications. In the network of severe pain, Conventional self-expandable nitinol alloy covered stent (p-score = 0.73, polyflex (p-score = 0.79, latex prosthesis (p-score = 0.96 and brachytherapy (p-score = 0.65 were better treatments.According to our results, thermal ablative therapy, covered Evolution® stents, brachytherapy, and antireflux stents are associated with a lower risk of TRD. Moreover, thermal ablative therapy, conventional, covered Evolution® and brachytherapy had lower risks of bleeding. Overall, fewer complications were associated with covered Evolution® stent and brachytherapy.

  20. Complications of stent placement in patients with esophageal cancer: A systematic review and network meta-analysis

    Science.gov (United States)

    Doosti-Irani, Amin; Mansournia, Mohammad Ali; Rahimi-Foroushani, Abbas; Haddad, Peiman

    2017-01-01

    Background Palliative treatments and stents are necessary for relieving dysphagia in patients with esophageal cancer. The aim of this study was to simultaneously compare available treatments in terms of complications. Methods Web of Science, Medline, Scopus, Cochrane Library and Embase were searched. Statistical heterogeneity was assessed using the Chi2 test and was quantified by I2. The results of this study were summarized in terms of Risk Ratio (RR). The random effects model was used to report the results. The rank probability for each treatment was calculated using the p-score. Results Out of 17855 references, 24 RCTs reported complications including treatment related death (TRD), bleeding, stent migration, aspiration, severe pain and fistula formation. In the ranking of treatments, thermal ablative therapy (p-score = 0.82), covered Evolution® stent (p-score = 0.70), brachytherapy (p-score = 0.72) and antireflux stent (p-score = 0.74) were better treatments in the network of TRD. Thermal ablative therapy (p-score = 0.86), the conventional stent (p-score = 0.62), covered Evolution® stent (p-score = 0.96) and brachytherapy (p-score = 0.82) were better treatments in the network of bleeding complications. Covered Evolution® (p-score = 0.78), uncovered (p-score = 0.88) and irradiation stents (p-score = 0.65) were better treatments in network of stent migration complications. In the network of severe pain, Conventional self-expandable nitinol alloy covered stent (p-score = 0.73), polyflex (p-score = 0.79), latex prosthesis (p-score = 0.96) and brachytherapy (p-score = 0.65) were better treatments. Conclusion According to our results, thermal ablative therapy, covered Evolution® stents, brachytherapy, and antireflux stents are associated with a lower risk of TRD. Moreover, thermal ablative therapy, conventional, covered Evolution® and brachytherapy had lower risks of bleeding. Overall, fewer complications were associated with covered Evolution® stent and

  1. Endoscopic bilateral stent-in-stent placement for malignant hilar obstruction using a large cell type stent.

    Science.gov (United States)

    Park, Jin Myung; Lee, Sang Hyub; Chung, Kwang Hyun; Jang, Dong Kee; Ryu, Ji Kon; Kim, Yong-Tae; Lee, Jae Min; Paik, Woo Hyun

    2016-12-01

    Bilateral stent-in-stent (SIS) self-expandable metal stent placement is technically challenging for palliation of unresectable malignant hilar obstruction. In the SIS technique, the uniform large cell type biliary stent facilitates contralateral stent deployment through the mesh of the first metallic stent. This study aimed to assess the technical success and clinical effectiveness of this technique with a uniform large cell type biliary stent. Thirty-one patients who underwent bilateral SIS placement using a large cell type stent were reviewed retrospectively. All patients showed malignant hilar obstruction (Bismuth types II, III, IV) with different etiologies. Sixteen (51.6%) patients were male. The mean age of the patients was 67.0+/-14.0 years. Most patients were diagnosed as having hilar cholangiocarcinoma (58.1%) and gallbladder cancer (29.0%). Technical success rate was 83.9%. Success was achieved more frequently in patients without masses obstructing the biliary confluence (MOC) than those with MOC (95.2% vs 60.0%, P=0.03). Functional success rate was 77.4%. Complications occurred in 29.0% of the patients. These tended to occur more frequently in patients with MOC (50.0% vs 19.0%, P=0.11). Median time to recurrent biliary obstruction was 188 days and median survival was 175 days. The large cell type stent can be used efficiently for bilateral SIS placement in malignant hilar obstruction. However, the risk of technical failure increases in patients with MOC, and caution is needed to prevent complications for these patients.

  2. Partially Covered Metal Stents May Not Prolong Stent Patency Compared to Uncovered Stents in Unresectable Malignant Distal Biliary Obstruction

    Science.gov (United States)

    Kim, Jae Yun; Ko, Gyu Bong; Lee, Tae Hoon; Park, Sang-Heum; Lee, Yun Nah; Cho, Young Sin; Jung, Yunho; Chung, Il-Kwun; Choi, Hyun Jong; Cha, Sang-Woo; Moon, Jong Ho; Cho, Young Deok; Kim, Sun-Joo

    2017-01-01

    Background/Aims Controversy still exists regarding the benefits of covered self-expandable metal stents (SEMSs) compared to uncovered SEMSs. We aimed to compare the patency and stent-related adverse events of partially covered SEMSs (PC-SEMSs) and uncovered SEMSs in unresectable malignant distal biliary obstruction. Methods A total of 134 patients who received a PC-SEMS or uncovered SEMS for palliation of unresectable malignant distal biliary obstruction were reviewed retrospectively. The main outcome measures were stent patency, stent-related adverse events, and overall survival. Results The median stent patency was 118 days (range, 3 to 802 days) with PC-SEMSs and 105 days (range, 2 to 485 days) with uncovered SEMSs (p=0.718). The overall endoscopic revision rate due to stent dysfunction was 36.6% (26/71) with PC-SEMSs and 36.5% (23/63) with uncovered SEMSs (p=0.589). Tumor ingrowth was more frequent with uncovered SEMSs (4.2% vs 19.1%, p=0.013), but migration was more frequent with PC-SEMSs (11.2% vs 1.5%, p=0.04). The incidence of stent-related adverse events was 2.8% (2/71) with PC-SEMSs and 9.5% (6/63) with uncovered SEMSs (p=0.224). The median overall survival was 166 days with PC-SEMSs and 168 days with uncovered SEMSs (p=0.189). Conclusions Compared to uncovered SEMSs, PC-SEMSs did not prolong stent patency in unresectable malignant distal biliary obstruction. Stent migration was more frequent with PC-SEMSs. However, tumor ingrowth was less frequent with PC-SEMSs compared to uncovered SEMSs. PMID:28208003

  3. Nine-month Angiographic and Two-year Clinical Follow-up of Novel Biodegradable-polymer Arsenic Trioxide-eluting Stent Versus Durable-polymer Sirolimus-eluting Stent For Coronary Artery Disease

    Directory of Open Access Journals (Sweden)

    Li Shen

    2015-01-01

    Full Text Available Background: Despite great reduction of in-stent restenosis, first-generation drug-eluting stents (DESs have increased the risk of late stent thrombosis due to delayed endothelialization. Arsenic trioxide, a natural substance that could inhibit cell proliferation and induce cell apoptosis, seems to be a promising surrogate of sirolimus to improve DES performance. This randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent (AES, compared with traditional sirolimus-eluting stent (SES. Methods: Patients with symptoms of angina pectoris were enrolled and randomized to AES or SES group. The primary endpoint was target vessel failure (TVF, and the second endpoint includes rates of all-cause death, cardiac death or myocardial infarction, target lesion revascularization (TLR by telephone visit and late luminal loss (LLL at 9-month by angiographic follow-up. Results: From July 2007 to 2009, 212 patients were enrolled and randomized 1:1 to receive either AES or SES. At 2 years of follow-up, TVF rate was similar between AES and SES group (6.67% vs. 5.83%, P = 0.980. Frequency of all-cause death was significantly lower in AES group (0 vs. 4.85%, P = 0.028. There was no significant difference between AES and SES in frequency of TLR and in-stent restenosis, but greater in-stent LLL was observed for AES group (0.29 ± 0.52 mm vs. 0.10 ± 0.25 mm, P = 0.008. Conclusions: After 2 years of follow-up, AES demonstrated comparable efficacy and safety to SES for the treatment of de novo coronary artery lesions.

  4. Flexibility and trackability of laser cut coronary stent systems.

    Science.gov (United States)

    Szabadíts, Péter; Puskás, Zsolt; Dobránszky, János

    2009-01-01

    Coronary stents are the most important supports in present day cardiology. Flexibility and trackability are two basic features of stents. In this paper, four different balloon-expandable coronary stent systems were investigated mechanically in order to compare their suitability. The coronary stent systems were assessed by measurements of stent flexibility as well as by comparison of forces during simulated stenting in a self-investigated coronary vessel model. The stents were cut by laser from a single tube of 316L stainless steel or L-605 (CoCr) cobalt chromium alloy. The one-and four-point bending tests were carried out to evaluate the stent flexibility E x I (Nmm(2)), under displacement control in crimped and expanded configurations. The flexibility of stents would be rather dependent on the design than on raw material. In general a more flexible stent needs lower tracking force during the implantation. The L-605 raw material stents need lower track force to pass through in the vessel model than the 316L raw material stents. The sort and long stents passed through the curved vessel model in different ways. The long stents nestled to the vessel wall at the outer arc and bent, while the short stents did not bend in the curve, only the delivery systems bent.

  5. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials.

    Science.gov (United States)

    Planer, David; Smits, Pieter C; Kereiakes, Dean J; Kedhi, Elvin; Fahy, Martin; Xu, Ke; Serruys, Patrick W; Stone, Gregg W

    2011-10-01

    This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown. We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD). At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p SPIRIT II]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the

  6. Tracheal obstruction caused by an expandable metallic stent: a case of successful removal of the stent.

    Science.gov (United States)

    Okuyama, Hiroomi; Kubota, Akio; Kawahara, Hisayoshi; Oue, Takaharu; Nose, Satoko; Ihara, Toshiyuki

    2005-07-01

    We report a case of tracheal obstruction caused by an expandable metallic stent. A 3-month-old girl with severe tracheomalacia had a placement of a Palmaz stent. At 3 years of age, she developed progressive dyspnea. The CT scan showed tracheal obstruction caused by granulation tissue over the stent. At operation, the stent was found to have penetrated the posterior tracheal wall. Under partial cardiopulmonary bypass, the stent was removed along with the membranous wall of the trachea, and the trachea was reconstructed using slide tracheoplasty. Tracheal obstruction is one of the serious complications caused by an expandable metallic stent. Direct open approach to the trachea under cardiopulmonary bypass is thought to be a safe way to manage this problem.

  7. TOKYO criteria 2014 for transpapillary biliary stenting.

    Science.gov (United States)

    Isayama, Hiroyuki; Hamada, Tsuyoshi; Yasuda, Ichiro; Itoi, Takao; Ryozawa, Shomei; Nakai, Yousuke; Kogure, Hirofumi; Koike, Kazuhiko

    2015-01-01

    It is difficult to carry out meta-analyses or to compare the results of different studies of biliary stents because there is no uniform evaluation method. Therefore, a standardized reporting system is required. We propose a new standardized system for reporting on biliary stents, the 'TOKYO criteria 2014', based on a consensus among Japanese pancreatobiliary endoscopists. Instead of stent occlusion, we use recurrent biliary obstruction, which includes occlusion and migration. The time to recurrent biliary obstruction was estimated using Kaplan-Meier analysis with the log-rank test. We can evaluate both plastic and self-expandable metallic stents (uncovered and covered). We also propose specification of the cause of recurrent biliary obstruction, identification of complications other than recurrent biliary obstruction, indication of severity, measures of technical and clinical success, and a standard for clinical care. Most importantly, the TOKYO criteria 2014 allow comparison of biliary stent quality across studies. Because blocked stents can be drained not only using transpapillary techniques but also by an endoscopic ultrasonography-guided transmural procedure, we should devise an evaluation method that includes transmural stenting in the near future. © 2014 The Authors. Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society.

  8. Targeting In-Stent-Stenosis with RGD- and CXCL1-Coated Mini-Stents in Mice.

    Science.gov (United States)

    Simsekyilmaz, Sakine; Liehn, Elisa A; Weinandy, Stefan; Schreiber, Fabian; Megens, Remco T A; Theelen, Wendy; Smeets, Ralf; Jockenhövel, Stefan; Gries, Thomas; Möller, Martin; Klee, Doris; Weber, Christian; Zernecke, Alma

    2016-01-01

    Atherosclerotic lesions that critically narrow the artery can necessitate an angioplasty and stent implantation. Long-term therapeutic effects, however, are limited by excessive arterial remodeling. We here employed a miniaturized nitinol-stent coated with star-shaped polyethylenglycole (star-PEG), and evaluated its bio-functionalization with RGD and CXCL1 for improving in-stent stenosis after implantation into carotid arteries of mice. Nitinol foils or stents (bare metal) were coated with star-PEG, and bio-functionalized with RGD, or RGD/CXCL1. Cell adhesion to star-PEG-coated nitinol foils was unaltered or reduced, whereas bio-functionalization with RGD but foremost RGD/CXCL1 increased adhesion of early angiogenic outgrowth cells (EOCs) and endothelial cells but not smooth muscle cells when compared with bare metal foils. Stimulation of cells with RGD/CXCL1 furthermore increased the proliferation of EOCs. In vivo, bio-functionalization with RGD/CXCL1 significantly reduced neointima formation and thrombus formation, and increased re-endothelialization in apoE-/- carotid arteries compared with bare-metal nitinol stents, star-PEG-coated stents, and stents bio-functionalized with RGD only. Bio-functionalization of star-PEG-coated nitinol-stents with RGD/CXCL1 reduced in-stent neointima formation. By supporting the adhesion and proliferation of endothelial progenitor cells, RGD/CXCL1 coating of stents may help to accelerate endothelial repair after stent implantation, and thus may harbor the potential to limit the complication of in-stent restenosis in clinical approaches.

  9. Stent underexpansion in angiographic guided percutaneous coronary intervention, despite adjunctive balloon post-dilatation, in drug eluting stent era

    Directory of Open Access Journals (Sweden)

    Mehrdad Taherioun

    2014-01-01

    Full Text Available BACKGROUND: Stent underexpansion is the most powerful predictor of long-term stent patency and clinical outcome. The purpose of this study was to evaluate the incidence and predictors of stent underexpansion despite adjunctive post-dilatation with non-compliant balloon. METHODS: After elective coronary stent implantation and adjunctive post-dilatation with non-compliant balloon and optimal angiographic result confirmed by the operator, intravascular ultrasound (IVUS was performed for all the treated lesions. If the treated lesions fulfilled the IVUS criteria, they are considered as the optimal stent group; if not, they are considered as the suboptimal group. RESULTS: From 50 patients enrolled in this study 39 (78% had optimal stent deployment and 11 (22% had suboptimal stent deployment. In the suboptimal group 7 (14% had underexpansion, 2 (4% malposition, and 2 (4% had asymmetry. There were no stent edge dissections detected by IVUS. We did not find any correlation between lesion calcification, ostial lesions, stent length, and stent underexpansion. Stent diameter ≤ 2.75 mm had a strong correlation with stent underexpansion. CONCLUSION: Despite adjunctive post-dilatation with noncompliant balloon, using a relatively small stent diameter was a strong predictor for underexpansion. IVUS guided percutaneous coronary intervention (PCI may be considered for drug eluting stent (DES implantation in relatively small vessels.   Keywords: Stent, Percutaneous Coronary Intervention, Ultrasound, Post-dilatation 

  10. Covered versus Uncovered Self-Expandable Metal Stents for Managing Malignant Distal Biliary Obstruction: A Meta-Analysis.

    Science.gov (United States)

    Li, Jinjin; Li, Tong; Sun, Ping; Yu, Qihong; Wang, Kun; Chang, Weilong; Song, Zifang; Zheng, Qichang

    2016-01-01

    To compare the efficacy of using covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (UCSEMSs) to treat objective jaundice caused by an unresectable malignant tumor. We performed a comprehensive electronic search from 1980 to May 2015. All randomized controlled trials comparing the use of CSEMSs and UCSEMSs to treat malignant distal biliary obstruction were included. The analysis included 1417 patients enrolled in 14 trials. We did not detect significant differences between the UCSEMS group and the CSEMS group in terms of cumulative stent patency (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.19-4.53; p = 0.93, I2 = 0%), patient survival (HR 0.77, 95% CI 0.05-10.87; p = 0.85, I2 = 0%), overall stent dysfunction (relative ratio (RR) 0.85, M-H, random, 95% CI 0.57-1.25; p = 0.83, I2 = 63%), the overall complication rate (RR 1.26, M-H, fixed, 95% CI 0.94-1.68; p = 0.12, I2 = 0%) or the change in serum bilirubin (weighted mean difference (WMD) -0.13, IV fixed, 95% CI 0.56-0.3; p = 0.55, I2 = 0%). However, we did detect a significant difference in the main causes of stent dysfunction between the two groups. In particular, the CSEMS group exhibited a lower rate of tumor ingrowth (RR 0.25, M-H, random, 95% CI 0.12-0.52; p = 0.002, I2 = 40%) but a higher rate of tumor overgrowth (RR 1.76, M-H, fixed, 95% CI 1.03-3.02; p = 0.04, I2 = 0%). Patients with CSEMSs also exhibited a higher migration rate (RR 9.33, M-H, fixed, 95% CI 2.54-34.24; p = 0.008, I2 = 0%) and a higher rate of sludge formation (RR 2.47, M-H, fixed, 95% CI 1.36-4.50; p = 0.003, I2 = 0%). Our meta-analysis indicates that there is no significant difference in primary stent patency and stent dysfunction between CSEMSs and UCSEMSs during the period from primary stent insertion to primary stent dysfunction or patient death. However, when taking further management for occluded stents into consideration, CSEMSs is a better choice for patients with malignant biliary

  11. Stent-assisted angioplasty for intracranial atherosclerosis

    International Nuclear Information System (INIS)

    Nakahara, Toshinori; Sakamoto, Shigeyuki; Hamasaki, Osamu; Sakoda, Katsuaki

    2002-01-01

    We report on two patients with intracranial atherosclerosis of the carotid artery or vertebral artery treated with stent-assisted angioplasty. Both patients have severe intracranial atherosclerosis (>70%) with refractory symptoms despite optimal medical treatment. In both patients, a coronary balloon-expandable stent was successfully placed using a protective balloon technique without procedural complications. The patients were asymptomatic and neurologically intact at a mean clinical follow-up of 13 months. Follow-up angiograms did not show restenosis 3 or 4 months after procedure, respectively. Stent-assisted angioplasty for intracranial atherosclerosis in the elective patient has proven effective, with an acceptable low rate of morbidity and mortality. (orig.)

  12. Drug-eluting stents and bare metal stents in patients with NSTE-ACS

    DEFF Research Database (Denmark)

    Pedersen, Sune Haahr; Pfisterer, Matthias; Kaiser, Christoph

    2014-01-01

    the randomised BASKET-PROVE trial (sirolimus-eluting stent vs. everolimus-eluting stent vs. bare metal stent in large-vessel stenting). The primary endpoint was the combined two-year rate of cardiovascular death or non-fatal myocardial infarction (MI). Secondary endpoints were each component of the primary...... implantation in large vessels was associated with a reduction in both TVR and the combined endpoint consisting of cardiovascular death/MI. Thus, DES use improves both efficacy and safety. These findings support the use of DES in NSTE-ACS patients....

  13. Treatment of Post-Stent Gastroesophageal Reflux by Anti-Reflux Z-Stent

    International Nuclear Information System (INIS)

    Davies, Roger Philip; Kew, Jacqueline; Byrne, Peter D.

    2000-01-01

    Severe symptoms of heartburn and retrosternal pain consistent with gastro-esophageal reflux (GER) developed in a patient following placement of a conventional self-expanding 16-24-mm-diameter x 12-cm-long esophageal stent across the gastroesophageal junction to treat an obstructing esophageal carcinoma. A second 18-mm-diameter x 10-cm-long esophageal stent with anti-reflux valve was deployed coaxially and reduced symptomatic GER immediately. Improvement was sustained at 4-month follow-up. An anti-reflux stent can be successfully used to treat significant symptomatic GER after conventional stenting

  14. Comparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Junker, Anders

    2012-01-01

    Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents...... (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point...... was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients...

  15. [Developments in percutaneous coronary intervention and coronary stents].

    Science.gov (United States)

    Simsek, C; Daemen, J; Zijlstra, F

    2014-01-01

    In The Netherlands, more than 30.000 patients undergo a percutaneous coronary intervention every year, during which a coronary stent implantation will be performed in 90% of the cases. It is estimated that more than 5 million coronary stent implantations will be performed worldwide this year. While these numbers are impressive, however, coronary stents still have as a limitation the possibility of stent thrombosis. This has been and is an important stimulus for the development of both coronary stents, from a bare metal stent via a drug eluting stent to the present-day development of bio-absorbable stents, and anti-platelet drugs,from acenocoumarol to thieropyridines. The possibility of shortening the period of use of this powerful medication by developing new kinds of non-thrombogenic stents would, for example, make it possible to achieve significant reductions in subsequent bleeding during (dental) procedures.

  16. Covered duodenal self-expandable metal stents prolong biliary stent patency in double stenting: The largest series of bilioduodenal obstruction.

    Science.gov (United States)

    Hori, Yasuki; Naitoh, Itaru; Hayashi, Kazuki; Kondo, Hiromu; Yoshida, Michihiro; Shimizu, Shuya; Hirano, Atsuyuki; Okumura, Fumihiro; Ando, Tomoaki; Jinno, Naruomi; Takada, Hiroki; Togawa, Shozo; Joh, Takashi

    2018-03-01

    Endoscopic biliary and duodenal stenting (DS; double stenting) is widely accepted as a palliation therapy for malignant bilioduodenal obstruction. The aim of the current study was to investigate the patency and adverse events of duodenal and biliary stents in patients with DS. Patients who underwent DS from April 2004 to March 2017 were analyzed retrospectively with regard to clinical outcomes and predictive factors of recurrent biliary and duodenal obstruction (recurrent biliary obstruction [RBO] and recurrent duodenal obstruction [RDO]). A total of 109 consecutive patients was enrolled. Technical success of DS was achieved in 108 patients (99.1%). Symptoms due to biliary and duodenal obstruction were improved in 89 patients (81.7%). RBO occurred in 25 patients (22.9%) and RDO in 13 (11.9%). The median times to RBO and RDO from DS were 87 and 76 days, respectively. Placement of a duodenal uncovered self-expandable metal stent (U-SEMS) was significantly associated with RBO in the multivariable analysis (P = 0.007). Time to RBO was significantly longer in the duodenal covered self-expandable metal stent group than in the U-SEMS group (P = 0.003). No predictive factors of RDO were detected, and duodenal stent type was not associated with the time to RDO (P = 0.724). Double stenting was safe and effective for malignant bilioduodenal obstruction. Duodenal U-SEMS is a risk factor for RBO. The covered self-expandable metal stent is the preferred type of duodenal SEMS in patients with DS (Clinical trial registration number: UMIN000027606). © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

  17. Mechanical design of an intracranial stent for treating cerebral aneurysms.

    Science.gov (United States)

    Shobayashi, Yasuhiro; Tanoue, Tetsuya; Tateshima, Satoshi; Tanishita, Kazuo

    2010-11-01

    Endovascular treatment of cerebral aneurysms using stents has advanced markedly in recent years. Mechanically, a cerebrovascular stent must be very flexible longitudinally and have low radial stiffness. However, no study has examined the stress distribution and deformation of cerebrovascular stents using the finite element method (FEM) and experiments. Stents can have open- and closed-cell structures, and open-cell stents are used clinically in the cerebrovasculature because of their high flexibility. However, the open-cell structure confers a risk of in-stent stenosis due to protrusion of stent struts into the normal parent artery. Therefore, a flexible stent with a closed-cell structure is required. To design a clinically useful, highly flexible, closed-cell stent, one must examine the mechanical properties of the closed-cell structure. In this study, we investigated the relationship between mesh patterns and the mechanical properties of closed-cell stents. Several mesh patterns were designed and their characteristics were studied using numerical simulation. The results showed that the bending stiffness of a closed-cell stent depends on the geometric configuration of the stent cell. It decreases when the stent cell is stretched in the circumferential direction. Mechanical flexibility equal to an open-cell structure was obtained in a closed-cell structure by varying the geometric configuration of the stent cell. Copyright © 2010 IPEM. Published by Elsevier Ltd. All rights reserved.

  18. Effects of 32P radioactive stents on in-stent restenosis in a double stent injury model of the porcine coronary arteries

    International Nuclear Information System (INIS)

    Kim, Han-Soo; Chan, Rosanna C.; Kollum, Marc; Au, Arthur; Tio, Fermin O.; Yazdi, Hamid A.; Ajani, Andrew E.; Waksman, Ron

    2001-01-01

    Background: The major limitation of coronary stenting remains in-stent restenosis, due to the development of neointimal proliferation. Radioactive stents have demonstrated the ability to reduce this proliferation in the healthy nonatherosclerotic porcine animal model. However, inhibition of tissue proliferation in the in-stent restenotic lesion in a porcine model is not well characterized. The objective of this study was to examine the efficacy and safety of the 32 P radioactive stent for the treatment of in-stent restenosis in a double stent injury model of the porcine coronaries. Methods and Materials: Eighteen coronary arteries in 9 pigs underwent nonradioactive stent (8 mm in length) implantation. Thirty days after the initial stent implantation, a 32 P radioactive stent (18 mm in length) with an activity of 0 and 18 μCi was implanted to cover the initial stent. The swine were killed 30 days after the second stent implantation. Histomorphometric analysis was performed for vessel area (VA), stent strut area (SSA), intimal area (IA), and lumen area (LA). Results: Injury scores, VA, SSA, and LA were similar among the control and radiated groups. Neointimal formation was significantly reduced after placement of radioactive stents as compared to control in both the overlapped (0.93±0.12 vs. 1.31±0.51 mm 2 , p 2 , p 32 P radioactive stents may be safe and effective in reducing neointimal formation leading to in-stent restenosis. Longer follow-up will be required to examine whether these positive findings can be maintained

  19. Stent Fracture and Reocclusion After Placement of a Single Self-Expanding Stent in the Common Iliac Artery and Endovascular Treatment

    International Nuclear Information System (INIS)

    Higashiura, Wataru; Sakaguchi, Shoji; Morimoto, Kengo; Kichikawa, Kimihiko

    2008-01-01

    We present a case of fracture of a single self-expanding stent placed in the common iliac artery (CIA). An 80-year-old woman underwent placement of a self-expanding stent for CIA occlusion. Stent fracture and reocclusion were detected after 18 months. Successful revascularization was achieved using a stent-in-stent maneuver. The possibility of stent fracture with reocclusion should be considered following treatment with a single self-expanding stent for CIA occlusion.

  20. Clinical Outcome After DK Crush Versus Culotte Stenting of Distal Left Main Bifurcation Lesions: The 3-Year Follow-Up Results of the DKCRUSH-III Study.

    Science.gov (United States)

    Chen, Shao-Liang; Xu, Bo; Han, Ya-Ling; Sheiban, Imad; Zhang, Jun-Jie; Ye, Fei; Kwan, Tak W; Paiboon, Chitprapai; Zhou, Yu-Jie; Lv, Shu-Zheng; Dangas, George D; Xu, Ya-Wei; Wen, Shang-Yu; Hong, Lang; Zhang, Rui-Yan; Wang, Hai-Chang; Jiang, Tie-Ming; Wang, Yan; Sansoto, Teguh; Chen, Fang; Yuan, Zu-Yi; Li, Wei-Min; Leon, Martin B

    2015-08-24

    The present study aimed to investigate the difference in major adverse cardiac events (MACE) at 3 years after double-kissing (DK) crush versus culotte stenting for unprotected left main distal bifurcation lesions (LMDBLs). The multicenter and randomized DKCRUSH-III (Comparison of double kissing crush versus culotte stenting for unprotected distal left main bifurcation lesions: results from a multicenter, randomized, prospective study) showed that DK crush stenting was associated with fewer MACE at 1-year follow-up in patients with LMDBLs compared with culotte stenting. Here, we report the 3-year clinical outcome of the DKCRUSH-III study. A total of 419 patients with LMDBLs who were randomly assigned to either the DK crush or culotte group in the DKCRUSH-III study were followed for 3 year. The primary endpoint was the occurrence of a MACE at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by simple and complex LMDBLs according to the DEFINITION (Definition and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) study criteria. At 3 years, MACE occurred in 49 patients the culotte group and in 17 patients in the DK crush group (cumulative event rates of 23.7% and 8.2%, respectively; p DK crush group (p = 0.007). Complex LMDBLs were associated with a higher rate of MACE (35.3%) at 3 years compared with a rate of 8.1% in patients with simple LMDBLs (p DK] Crush Versus Culotte Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions: DKCRUSH-III, a Multicenter Randomized Study Comparing Double-Stent Techniques; ChiCTR-TRC-11001877). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. Long-Term Results After Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions Nordic Bifurcation Study 5-Year Follow-Up Results

    DEFF Research Database (Denmark)

    Maeng, M.; Holm, N. R.; Erglis, A.

    2013-01-01

    Objectives This study sought to report the 5-year follow-up results of the Nordic Bifurcation Study. Background Randomized clinical trials with short-term follow-up have indicated that coronary bifurcation lesions may be optimally treated using the optional side branch stenting strategy. Methods...... complex strategy of planned stenting of both the main vessel and the side branch. (C) 2013 by the American College of Cardiology Foundation...

  2. Functional Self-Expandable Metal Stents in Biliary Obstruction

    Science.gov (United States)

    Kwon, Chang-Il; Ko, Kwang Hyun; Hahm, Ki Baik

    2013-01-01

    Biliary stents are widely used not only for palliative treatment of malignant biliary obstruction but also for benign biliary diseases. Each plastic stent or self-expandable metal stent (SEMS) has its own advantages, and a proper stent should be selected carefully for individual condition. To compensate and overcome several drawbacks of SEMS, functional self-expandable metal stent (FSEMS) has been developed with much progress so far. This article looks into the outcomes and defects of each stent type for benign biliary stricture and describes newly introduced FSEMSs according to their functional categories. PMID:24143314

  3. Biomimicry, vascular restenosis and coronary stents.

    Science.gov (United States)

    Schwartz, R S; van der Giessen, W J; Holmes, D R

    1998-01-01

    Biomimicry is in its earliest stages and is being considered in the realm of tissue engineering. If arterial implants are to limit neointimal thickening, purely passive structures cannot succeed. Bioactivity must be present, either by pharmacologic intervention or by fabricating a 'living stent' that contains active cellular material. As tissue engineering evolves, useful solutions will emerge from applying this knowledge directly to vascular biologic problems resulting from angioplasty, stenting, and vascular prosthesis research.

  4. Nasolacrimal Polyurethane Stent: Complications with CT Correlation

    International Nuclear Information System (INIS)

    Pinto, Isabel T.; Paul, Laura; Grande, Carlos

    1998-01-01

    Purpose: To evaluate initial results in patients with epiphora secondary to obstruction of the nasolacrimal duct treated by placement of a polyurethane stent, and to discuss the technical problems and complications arising during the procedure, with visualization of the anatomy of the drainage apparatus using computed tomography (CT). Methods: We inserted 20 polyurethane Song stents under fluoroscopic guidance after dacryocystography in 19 patients with grade 3-4 epiphora caused by idiopathic obstruction of the nasolacrimal duct. CT scans were obtained following stent placement in all patients. Results: We focus on the technical problems and complications that arose during these procedures. During negotiation of the guidewire past the obstruction at the level of the junction of the duct with the lacrimal sac, the guidewire created a false passage in a posterior suborbital direction in two cases and towards the posterior midline in another. In all cases the guidewire was withdrawn and reinserted through the proper anatomic route without further difficulty or complications. In two cases the stent was improperly positioned wholly or partially outside the nasolacrimal system (one medially, one posteriorly). In one case the stent was removed and reinserted; in the other it remains in place and functional. CT was performed in all these cases to ensure proper anatomic alignment and determine what had gone wrong. The epiphora was completely resolved in 13 cases and partially relieved in four; there were three cases of stent obstruction. Epistaxis of short duration (1 hr) occurred in seven patients and headache in one. Conclusions: Treatment of epiphora with polyurethane stents is a technique that is well tolerated by patients and achieves a high success rate, yet problems in placement may be encountered. Though no major consequences for patients are involved, cognizance of such difficulties is important to avoid incorrect positioning of stents

  5. Hemi-Intravascular Stenting for Supermicrosurgical Anastomosis

    OpenAIRE

    Kensuke Tashiro, MD; Shuji Yamashita, MD; Mitsunaga Narushima, MD; Isao Koshima, MD; Shimpei Miyamoto, MD

    2017-01-01

    Background:. Although supermicrosurgical anastomosis is a widely known reconstructive microsurgical technique, it is difficult to perform. To expand the clinical use of supermicrosurgery, we used hemi-intravascular stenting (hemi-IVaS), which is performed by inserting an intravascular stent into one side of the vessel. We conducted lymphaticovenular anastomosis, free perforator flap transfer, and fingertip replantation with supermicrosurgical anastomosis using hemi-IVaS technique and examined...

  6. Renal artery stent angioplasty for renovascular hypertension

    International Nuclear Information System (INIS)

    Li Gang; Li Haiqing; Wang Lin

    2005-01-01

    Objective: To evaluate the therapeutic results of expandable stent for treatment of atherosclerotic renovascular obstructive disease. Methods: 15 patients (10 men and 5 women, 41-75 years old; mean age, 52 years) with renal arterial hypertension underwent renal stent angioplasty including renal arterial stenosis 89%(n=13) and fully obstruction without function in 2, of which 2 patients had bilateral involvement. The stenotic range of all arterial segments showed 60% to 90% width of the normal arterial diameter. 16 stents were implanted under the guidance of fluoroscopy. The most of stents implanted were Palmaz (n=12, 75%) with regular clinical and angiographic follow up. Results: Technical success (residual stenosis <30%) was achieved in all patients without serious complication. During the follow-up (6-15 months; mean, 8 ± 4 months), hypertension was improved in 9 patients and cured in 4 patients with a total benefit of 86% and no efficacy in 2(13%). The average systolic blood pressure decreased from 27.12 ± 3.09 kPa to 18.62 ± 3.12 kPa and the average diastolic blood pressure decreased from 17.73 ± 1.92 kPa to 11.12 ± 2.43 kPa after stent treatment (P<0.05). Serum creatinine remained stable in 60% (n=9) patients with improvement in 33% (n=5) and worsened in 6% (n=1) patients. Follow-up angiography was performed in all patients with 1 case of a restenosis. 6 months after expanding through stent by using balloon, the two follow up angiographies showed a stable restenosis about 20%. Conclusions: Percutaneous transluminal stent placement is highly beneficial for patients who had renal arterial obstructive disease. The success of stent angioplasty of complete obstructive renal arteries reveals wide prospects for interventional method. (authors)

  7. The Bolton Treovance abdominal stent-graft: European clinical trial design.

    Science.gov (United States)

    Chiesa, R; Riambau, V; Coppi, G; Zipfel, B; Llagostera, S; Marone, E M; Kahlberg, A

    2012-10-01

    Endovascular aortic repair (EVAR) has emerged as a promising, less invasive alternative to conventional open surgery for the treatment of infrarenal abdominal aortic aneurysms (AAAs). In the last 20 years, the application rate of EVAR and its clinical results have significantly improved thanks to the evolution of stent-grafts and endovascular delivery systems. However, further development is still needed to reduce the incidence of complications and secondary re-interventions. The Treovance abdominal aortic stent-graft (Bolton Medical, Barcelona, Spain) is a new-generation endovascular device, developed to increase flexibility, lower profile, improve deployment and sealing mechanisms. In particular, it is provided with some innovative features as a double layer of proximal barbs (suprarenal and infrarenal) for supplemental fixation, dull barbs between modules to avoid potential leg disconnections, detachable outer sheath provided with a new-design hemostatic valve, and a double improved mechanism (slow motion and "pin and pull") for precise stent-graft deployment. A European prospective, non-randomized, multi-institutional, "first-in-human" trial (the ADVANCE trial) was conducted from March to December 2011 to assess the safety and performance of the Treovance stent-graft system before commercialization. Thirty patients with anatomically suitable non-ruptured AAAs were enrolled at five clinical sites in Italy, Spain, and Germany. EVAR was completed successfully in all patients. The stent-graft was delivered and deployed safely even in heavily angulated or calcified anatomies. No 30-day device-related complications nor deaths were observed. Preliminary experience with the Treovance abdominal stent-graft within the ADVANCE trial was satisfactory with regard to technical success and perioperative clinical results. Follow-up data are needed to assess mid- and long-term clinical outcomes, along with durability of this new-generation endovascular device.

  8. Experimental Evaluation of a New Single Wire Stainless Steel Fishscale Coronary Stent (Freedomª).

    Science.gov (United States)

    Wang; Verbeken; Mukherjee; Zhou; De Scheerder IK

    1996-10-01

    Recent randomized clinical trials revealed a significant reduction in angiographic restenosis rates when adjunctive stenting was performed after conventional coronary balloon angioplasty. Current approved coronary stents are however hampered by their rigidity, limiting their trackability in tortuous vessels and furthermore, needing high pressure deployment for optimal vessel apposition. New coronary stents are currently under development, using more biocompatible metal alloys and/or designs which better align to the vessel wall at moderate deployment pressures. We evaluated the safety, efficacy, angiographic and histological effect of a new stainless steel fishscale designed stent (Freedomª, Global Therapeutics, Co., USA) in a porcine coronary and peripheral artery model. Implantation in the right coronary artery was successful in all 20 pigs. Control angiograms at 6 weeks follow-up demonstrated patent vessels and morphologic evaluation showed only a mild fibromuscular neointimal response resulting in an area stenosis of 28.7 +/- 0.18% and a mean neointimal hyperplasia of 0.18 +/- 0.25 mm. Comparison with the Palmaz-Schatzª coronary stent in a porcine peripheral artery model demonstrated similar quantitative angiographic and morphologic vessel analysis results. Also the morphometric data were comparable. Area stenosis: Palmaz-Schatz: 37 +/- 0.24%, Freedom: 21 +/- 0.14%, p = 0.07. Mean neointimal hyperplasia: Palmaz-Schatz: 0.33 +/- 0.24 mm, Freedom: 0.18 +/- 0.08 mm, p = 0.08. CONCLUSION: Freedom coronary stent implantation in a porcine model resulted in a high procedural success without subacute thrombotic occlusions, despite no further anticoagulation nor antiplatelet therapy. Six weeks histopathological and morphometric evaluation demonstrated only a mild fibromuscular neointimal hyperplasia.

  9. Efficacy of percutaneous intraductal radiofrequency ablation combined with biliary stenting in treatment of malignant biliary obstruction

    Directory of Open Access Journals (Sweden)

    ZHANG Kai

    2015-05-01

    Full Text Available ObjectiveTo investigate the safety and feasibility of percutaneous intraductal radiofrequency ablation (palliative therapy in the treatment of malignant obstructive jaundice. MethodsThis study included 20 patients with unresectable malignant obstructive jaundice, who were treated in the First Affiliated Hospital of Zhengzhou University from January 2013 to March 2014. Nine of them (test group underwent percutaneous intraductal radiofrequency ablation plus metallic biliary stent placement. The other 11 similar cases (control group underwent metallic biliary stent placement alone after successful percutaneous transhepatic cholangiography. Operative complications and remission of jaundice were observed, and the stent patency after at 3 and 6 months after operation was evaluated and compared between the two groups. ResultsAll patients were followed completely by outpatient or telephone. The stent patency rate at 3 months after operation was 9/9 in the test group and 8/11 in the control group (χ2=2.888, P=0.218, and the stent patency rates at 6 months were 7/8 and 3/11, respectively (χ2=6.739, P=0.02. During follow-up, one case in the test group died of gastrointestinal bleeding at 113 d after operation; one case in the control group died of liver failure at 57 d after operation and one case died of disseminated intravascular coagulation at 142 d. ConclusionPercutaneous intraductal radiofrequency ablation is safe and feasible in the treatment of malignant biliary obstruction, and the preliminary efficacy in prolonging the patency of self-expanding metallic stent is satisfactory. However, this therapy needs to be further verified via large-sample randomized controlled studies.

  10. Outcomes of the single-stent versus kissing-stents technique in asymmetric complex aortoiliac bifurcation lesions.

    Science.gov (United States)

    Suh, Yongsung; Ko, Young-Guk; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Choi, Donghoon; Hong, Myeong-Ki; Jang, Yangsoo

    2015-07-01

    This study investigated the outcomes of single-stent vs kissing-stents techniques in asymmetric complex aortoiliac bifurcation (ACAB) lesions. We retrospectively investigated 80 consecutive patients (69 males, 66.6 ± 8.7 years) treated with a single stent and 30 patients (26 males, 67.1 ± 7.7 years) treated with kissing stents for ACAB between January 2005 and December 2012 from a single-center cohort. A ACAB lesion was defined as a symptomatic unilateral common iliac artery stenosis (>50%) combined with intermediate stenosis (30%-50%) in the contralateral common iliac artery ostium. The primary end point was the primary patency of the ACAB. The baseline clinical characteristics did not differ significantly between the single-stent and the kissing-stents group. Technical success was achieved in all patients. The single-stent group required fewer stents (1.3 ± 0.5 vs 2.3 ± 0.8; P stent group (3%) required bailout kissing stents because of plaque shift to the contralateral side. The major complication rates were 8% in single-stent vs 13% in the kissing-stent group, which was similar (P = .399). At 3 years, the single-stent and kissing-stents group had similar rates of primary patency (89% vs 87%; P = .916) and target lesion revascularization-free survival (93% vs 87%; P = .462). The single-stent technique in ACAB was safe and showed midterm outcomes comparable with those of kissing stents. Considering the benefits, such as fewer stents, less bilateral femoral access, and the availability of contralateral access for future intervention, the single-stent technique may be an advantageous treatment option in ACAB. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

  11. Ureteral stent discomfort: Etiology and management

    Directory of Open Access Journals (Sweden)

    Ricardo Miyaoka

    2009-01-01

    Full Text Available Objectives : To review the evidence-based literature on the causes, characteristics, and options to manage double J stent-related symptoms. Methods : We performed a Medline database assessment on papers that investigated the prevalence, mechanisms, risk factors, bothersome and management of double-J stent-related symptoms. Articles in English were reviewed and summarized. Results : Stent-related symptoms have a high prevalence and may affect over 80% of patients. They include irritative voiding symptoms including frequency, urgency, dysuria, incomplete emptying; flank and suprapubic pain; incontinence, and hematuria. Assessment tools are important to determine their intensity and allow for comparisons between different points in the timeline. The Urinary Stent Symptom Questionnaire (USSQ is the most proper tool used for this purpose. Management should be focused on the prevention and management of symptoms. In this sense, research has focused on new materials and stent designs that would be more compatible to the physiologic properties of the urinary tract and medications that can ameliorate the sensitivity and motor response of the bladder. Conclusions : Stent-related symptoms are very common in the Urological clinical setting. It is of major importance for the urologist to understand their physiopathology and to be familiar with ways to avoid or manage them.

  12. Computational micromechanics of bioabsorbable magnesium stents.

    Science.gov (United States)

    Grogan, J A; Leen, S B; McHugh, P E

    2014-06-01

    Magnesium alloys are a promising candidate material for an emerging generation of absorbable metal stents. Due to its hexagonal-close-packed lattice structure and tendency to undergo twinning, the deformation behaviour of magnesium is quite different to that of conventional stent materials, such as stainless steel 316L and cobalt chromium L605. In particular, magnesium exhibits asymmetric plastic behaviour (i.e. different yield behaviours in tension and compression) and has lower ductility than these conventional alloys. In the on-going development of absorbable metal stents it is important to assess how the unique behaviour of magnesium affects device performance. The mechanical behaviour of magnesium stent struts is investigated in this study using computational micromechanics, based on finite element analysis and crystal plasticity theory. The plastic deformation in tension and bending of textured and non-textured magnesium stent struts with different numbers of grains through the strut dimension is investigated. It is predicted that, unlike 316L and L605, the failure risk and load bearing capacity of magnesium stent struts during expansion is not strongly affected by the number of grains across the strut dimensions; however texturing, which may be introduced and controlled in the manufacturing process, is predicted to have a significant influence on these measures of strut performance. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. 4D phase contrast flow imaging for in-stent flow visualization and assessment of stent patency in peripheral vascular stents – A phantom study

    International Nuclear Information System (INIS)

    Bunck, Alexander C.; Jüttner, Alena; Kröger, Jan Robert; Burg, Matthias C.; Kugel, Harald; Niederstadt, Thomas; Tiemann, Klaus; Schnackenburg, Bernhard; Crelier, Gerard R.

    2012-01-01

    Purpose: 4D phase contrast flow imaging is increasingly used to study the hemodynamics in various vascular territories and pathologies. The aim of this study was to assess the feasibility and validity of MRI based 4D phase contrast flow imaging for the evaluation of in-stent blood flow in 17 commonly used peripheral stents. Materials and methods: 17 different peripheral stents were implanted into a MR compatible flow phantom. In-stent visibility, maximal velocity and flow visualization were assessed and estimates of in-stent patency obtained from 4D phase contrast flow data sets were compared to a conventional 3D contrast-enhanced magnetic resonance angiography (CE-MRA) as well as 2D PC flow measurements. Results: In all but 3 of the tested stents time-resolved 3D particle traces could be visualized inside the stent lumen. Quality of 4D flow visualization and CE-MRA images depended on stent type and stent orientation relative to the magnetic field. Compared to the visible lumen area determined by 3D CE-MRA, estimates of lumen patency derived from 4D flow measurements were significantly higher and less dependent on stent type. A higher number of stents could be assessed for in-stent patency by 4D phase contrast flow imaging (n = 14) than by 2D phase contrast flow imaging (n = 10). Conclusions: 4D phase contrast flow imaging in peripheral vascular stents is feasible and appears advantageous over conventional 3D contrast-enhanced MR angiography and 2D phase contrast flow imaging. It allows for in-stent flow visualization and flow quantification with varying quality depending on stent type

  14. 4D phase contrast flow imaging for in-stent flow visualization and assessment of stent patency in peripheral vascular stents--a phantom study.

    Science.gov (United States)

    Bunck, Alexander C; Jüttner, Alena; Kröger, Jan Robert; Burg, Matthias C; Kugel, Harald; Niederstadt, Thomas; Tiemann, Klaus; Schnackenburg, Bernhard; Crelier, Gerard R; Heindel, Walter; Maintz, David

    2012-09-01

    4D phase contrast flow imaging is increasingly used to study the hemodynamics in various vascular territories and pathologies. The aim of this study was to assess the feasibility and validity of MRI based 4D phase contrast flow imaging for the evaluation of in-stent blood flow in 17 commonly used peripheral stents. 17 different peripheral stents were implanted into a MR compatible flow phantom. In-stent visibility, maximal velocity and flow visualization were assessed and estimates of in-stent patency obtained from 4D phase contrast flow data sets were compared to a conventional 3D contrast-enhanced magnetic resonance angiography (CE-MRA) as well as 2D PC flow measurements. In all but 3 of the tested stents time-resolved 3D particle traces could be visualized inside the stent lumen. Quality of 4D flow visualization and CE-MRA images depended on stent type and stent orientation relative to the magnetic field. Compared to the visible lumen area determined by 3D CE-MRA, estimates of lumen patency derived from 4D flow measurements were significantly higher and less dependent on stent type. A higher number of stents could be assessed for in-stent patency by 4D phase contrast flow imaging (n=14) than by 2D phase contrast flow imaging (n=10). 4D phase contrast flow imaging in peripheral vascular stents is feasible and appears advantageous over conventional 3D contrast-enhanced MR angiography and 2D phase contrast flow imaging. It allows for in-stent flow visualization and flow quantification with varying quality depending on stent type. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  15. iStent as a Solo Procedure for Glaucoma Patients: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Malvankar-Mehta, Monali S; Chen, Yufeng Nancy; Iordanous, Yiannis; Wang, Wan Wendy; Costella, John; Hutnik, Cindy M L

    2015-01-01

    Glaucoma is a leading cause of irreversible blindness. It is firmly entrenched in the traditional treatment paradigm to start with pharmacotherapy. However, pharmacotherapy is not benign and has been well documented to have a number of significant challenges. Minimally invasive glaucoma surgery (MIGS) that targets the outflow pathway with minimal to no scleral dissection has resulted in the need to reconsider the glaucoma treatment paradigm. To perform a systematic review and meta-analysis to evaluate and quantify the effect on post-operative intraocular pressure (IOP) and number of topical glaucoma medications, in patients receiving the iStent MIGS device as the solo procedure without concurrent cataract surgery. A systematic review was conducted by searching various databases between January 1, 2000, and June 30, 2014. Studies reporting up to a maximum follow-up period of 24 months were retrieved and screened using the EPPI-Reviewer 4 gateway. Percentage reduction in IOP (IOPR%), and mean reduction in topical glaucoma medications after surgery were computed. Meta-analysis was performed using STATA v. 13.0. The standardized mean difference (SMD) was calculated as the effect size for continuous scale outcomes. Heterogeneity was determined using the I2 statistics, Z-value, and χ2 statistics. Fixed-effect and random-effect models were developed based on heterogeneity. Sub-group analysis was performed based on the number of iStents implanted and the follow-up period. The outcome measures were changes in the IOP and number of glaucoma medications. The search strategy identified 105 records from published literature and 9 records from the grey literature. Five studies with 248 subjects were included for quantitative synthesis. A 22% IOP reduction (IOPR%) from baseline occurred at 18-months after one iStent implant, 30% at 6-months after two iStents implantations, and 40% at 6-months after implantation of three iStents. A mean reduction of 1.2 bottles per patient of

  16. Coronary artery aneurysm after stent implantation: acute and long-term results after percutaneous treatment with a stent graft.

    Science.gov (United States)

    Rubartelli, Paolo; Terzi, Giacomo; Borgo, Lorenzo; Giachero, Corinna

    2002-03-01

    A patient with unstable angina was treated with elective Palmaz-Schatz stent implantation on a focal stenosis of the left circumflex artery. One year later, a large (13 mm in diameter) coronary artery aneurysm was diagnosed at angiography in the stented site. Intravascular ultrasound examination confirmed the presence of a true aneurysm located at the proximal end of the stent. The aneurysm was successfully treated with a Jostent Graft (Jomed Implantate) consisting of two slotted tube stainless steel stents supporting a polytetrafluoroethylene tube. The stent graft was implanted under intravascular ultrasound guidance. The 18-month angiographic follow-up showed good patency of the stent graft and complete exclusion of the aneurysm.

  17. XIENCE V everolimus-eluting coronary stent system: a novel second generation drug-eluting stent

    NARCIS (Netherlands)

    Beijk, Marcel A. M.; Piek, Jon J.

    2007-01-01

    Drug-eluting stents (DES) have been shown to be safe and significantly reduce clinical events and angiographic restenosis in the percutaneous treatment of coronary artery disease. Currently, three DES have been approved in Europe and Northern America: the sirolimus-eluting stent (SES), the

  18. Mechanical properties of various z-stent designs: an endovascular stent-grafting perspective.

    Science.gov (United States)

    Bashar, Abul Hasan Muhammad; Kazui, Teruhisa; Washiyama, Naoki; Terada, Hitoshi; Yamashita, Katsushi; Haque, Mohammad E

    2003-08-01

    To comparatively assess the mechani-cal behavior of various clinically relevant Z-stent designs. A total of 16 Z-stents of original, biliary, spiral, and double-skirted designs (n=4 for each) were constructed using similar specifications for all. Stents were then evaluated for stiffness, snap opening force (SOF), flexibility, and displacement force using a novel tensiometer. Differences among the stents were determined using statistical methods. Stents explanted from dog aorta after a mean follow-up of 13 months were examined under a scanning electron microscope for surface defects. Forces required for about 50% reduction in diameter were 1.88 +/- 0.16 N, 3.81 +/- 0.21 N, 2.76 +/- 0.22 N, and 3.35 +/- 0.19 N for original, biliary, spiral, and skirted designs, respectively. Differences among the four designs were statistically significant at almost all points of measurement (P designs showed higher SOF values in the early measurements. Stents explanted from dog aorta after a mean duration of 13 months showed no obvious corrosion or breakage in the wire struts. Significant differences exist among the various Z-stent designs in terms of their mechanical properties. Understanding them should help to select the appropriate stent for a given lesion. 316L stainless steel shows a favorable long-term tissue interaction.

  19. Self-expandable nitinol stent placement in homocysteinemic porcine aorta

    Directory of Open Access Journals (Sweden)

    Luís Henrique Gil França

    2008-01-01

    Full Text Available PURPOSE: To compare aortic intimal thickening of normal and hyperhomocysteinemic pigs (induced with a methionine-rich diet following placement of a self-expanding nitinol stent. METHODS: Eighteen Macau pigs were used. They were older than eight weeks in age and had an average weight of 30 kg. Pigs were randomly divided into two groups. The first, Group C (control, was fed a regular diet, and the second group, Group M, was fed a methionine-rich diet for 30 days to induce hyperhomocysteinemia. The self-expandable nitinol stents were 25mm in length and 8 mm in diameter after expansion. Blood samples were collected to measure total cholesterol, triglycerides, HDL and homocysteine concentrations. All animals were subjected to angiography. Thirty days after the procedure, the animals were sacrificed, and the abdominal aorta was removed for histological and digital morphometry analysis. RESULTS: Under microscopic evaluation, the intima was significantly thicker in Group C than in Group M. When groups were compared by digital morphometric analysis, intimal thickening of the vessel wall was higher in Group C than in Group M. There was no significant change in total cholesterol, triglycerides or HDL concentrations in either group. In group C the levels of plasma homocysteine ranged from 14,40 to 16,73µmol/l; in Group M, plasma homocysteine levels ranged from 17.47 to 59.80 µmol/l after 30 days of a methionine-rich diet. CONCLUSION: Compared to normal pigs, less intimal hyperplasia was observed in the abdominal aortas of hyperhomocysteinemic pigs thirty days after the insertion of a self-expandable nitinol stent.

  20. Nitinol Esophageal Stents: New Designs and Clinical Indications

    International Nuclear Information System (INIS)

    Strecker, Ernst-Peter; Boos, Irene; Vetter, Sylvia; Strohm, Michael; Domschke, Sigurd

    1996-01-01

    Purpose: To evaluate the clinical use of covered and noncovered, knitted nitinol stents in patients presenting new stent indications. Methods: Self-expandable, knitted nitinol stents were implanted in four patients for treatment of dysphagia. In two patients who had malignant strictures and had esophago-respiratory fistulae and in one patient with an esophagocutaneous fistula, polytetrafluoroethylene (PTFE)-covered stents were implanted. One patient received a noncovered stent, but a retrograde approach through a percutaneous endoscopic gastrostomy (PEG) fistula had to be chosen for recanalization of an esophageal occlusion. Two patients received stents for treatment of benign strictures. Results: Recanalization of the stricture and stent implantation were performed under fluoroscopic control without any procedure-related morbidity or mortality. Dysphagia improved in all patients and the esophageal fistulae could be sealed off by covered stents. During a maximum follow-up of 18 months, there was no stent migration or esophageal perforation. Complications observed were stent stenosis due to food impaction (1/4) and benign stent stenosis (2/2). Most complications could be treated by the interventional radiologist. Conclusion: Self-expandable, covered Nitinol stents provide an option for the treatment of dysphagia combined with esophageal fistulae. In combination with interventional radiology techniques, even complex strictures are accessible. For benign strictures, the value of stent treatment has not yet been proven

  1. Risk Factors for Migration, Fracture, and Dislocation of Pancreatic Stents

    Directory of Open Access Journals (Sweden)

    Yoshiaki Kawaguchi

    2015-01-01

    Full Text Available Aim. To analyze the risk factors for pancreatic stent migration, dislocation, and fracture in chronic pancreatitis patients with pancreatic strictures. Materials and Methods. Endoscopic stent placements (total 386 times were performed in 99 chronic pancreatitis patients with pancreatic duct stenosis at our institution between April 2006 and June 2014. We retrospectively examined the frequency of stent migration, dislocation, and fracture and analyzed the patient factors and stent factors. We also investigated the retrieval methods for migrated and fractured stents and their success rates. Results. The frequencies of stent migration, dislocation, and fracture were 1.5% (5/396, 0.8% (3/396, and 1.2% (4/396, respectively. No significant differences in the rates of migration, dislocation, or fracture were noted on the patient factors (etiology, cases undergoing endoscopic pancreatic sphincterotomy, location of pancreatic duct stenosis, existence of pancreatic stone, and approach from the main or minor papilla and stent factors (duration of stent placement, numbers of stent placements, stent shape, diameter, and length. Stent retrieval was successful in all cases of migration. In cases of fractured stents, retrieval was successful in 2 of 4 cases. Conclusion. Stent migration, fracture, and dislocation are relatively rare, but possible complications. A good understanding of retrieval techniques is necessary.

  2. New expandable metallic stents: An experimental study in vessels of dogs

    International Nuclear Information System (INIS)

    Song, Ho Young; Lee, Jung Min; Chung, Jin Young; Chung, Gyung Ho; Kim, Bog Yi; Kuh, Ja Houng

    1992-01-01

    Three-types of expandable metallic stents were constructed to evaluate the differences between the stents: one, formed in a cylindrical zigzag pattern wth stainless steel wire (Gianturco stent), another, made by coating the Gianturco stent with silicone rubber (Silicone stent), the third, made by coating the Gianturco stent with 24 carat gold (Gold stent) for tissue acceptance. A total of 69 stents (each 23 stents of Gianturco, Silicone, and Gold stents) of 8-12 mm in diameter and 20 mm long were placed into normal abdominal aorta, inferior vena cava and lilac artery of nine adults dogs for 2 weeks to 11 months. It was more difficult to introduce Silicone stent into an introducing sheath than Gianturco or Gold stent due to the thickness of silicone rubber. Four Gianturco stents and three Silicone stents showed migration but Gold stent did not. Luminal narrowing or occlusion was noted in 3 Silicone stents. In 2 Gianturco stents, and in 1 Gold stent. Neointimal proliferation over the stent wires was more rapid and even in Gold stent than Silicone or Gianturco stent. Although further study is needed, Gold stent seems to be better than Gianturco or Silicone stent as an endovascular graft material

  3. New expandable metallic stents: An experimental study in vessels of dogs

    Energy Technology Data Exchange (ETDEWEB)

    Song, Ho Young; Lee, Jung Min; Chung, Jin Young; Chung, Gyung Ho; Kim, Bog Yi; Kuh, Ja Houng [Chunbuk National University Medical School, Chunju (Korea, Republic of)

    1992-07-15

    Three-types of expandable metallic stents were constructed to evaluate the differences between the stents: one, formed in a cylindrical zigzag pattern wth stainless steel wire (Gianturco stent), another, made by coating the Gianturco stent with silicone rubber (Silicone stent), the third, made by coating the Gianturco stent with 24 carat gold (Gold stent) for tissue acceptance. A total of 69 stents (each 23 stents of Gianturco, Silicone, and Gold stents) of 8-12 mm in diameter and 20 mm long were placed into normal abdominal aorta, inferior vena cava and lilac artery of nine adults dogs for 2 weeks to 11 months. It was more difficult to introduce Silicone stent into an introducing sheath than Gianturco or Gold stent due to the thickness of silicone rubber. Four Gianturco stents and three Silicone stents showed migration but Gold stent did not. Luminal narrowing or occlusion was noted in 3 Silicone stents. In 2 Gianturco stents, and in 1 Gold stent. Neointimal proliferation over the stent wires was more rapid and even in Gold stent than Silicone or Gianturco stent. Although further study is needed, Gold stent seems to be better than Gianturco or Silicone stent as an endovascular graft material.

  4. Three-year patient-related and stent-related outcomes of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice (from the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries).

    Science.gov (United States)

    Lee, Joo Myung; Park, Kyung Woo; Han, Jung-Kyu; Yang, Han-Mo; Kang, Hyun-Jae; Koo, Bon-Kwon; Bae, Jang-Whan; Woo, Sung-Il; Park, Jin Sik; Jin, Dong-Kyu; Jeon, Dong Woon; Oh, Seok Kyu; Park, Jong-Seon; Kim, Doo-Il; Hyon, Min Su; Jeon, Hui-Kyung; Lim, Do-Sun; Kim, Myeong-Gon; Rha, Seung-Woon; Her, Sung-Ho; Hwang, Jin-Yong; Kim, Sanghyun; Choi, Young Jin; Kang, Jin Ho; Moon, Keon-Woong; Jang, Yangsoo; Kim, Hyo-Soo

    2014-11-01

    Long-term outcomes are imperative to confirm safety of drug-eluting stents. There have been 2 randomized controlled trials comparing everolimus-eluting stents (EESs) and Resolute zotarolimus-eluting stents (ZES-Rs). To date, long-term clinical outcomes of these stents were limited to only 1 report, which has recently reported 4-year comparisons of these stents. Therefore, more evidence is needed regarding long-term clinical outcomes of the second-generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in "all-comer" cohorts up to 3-year follow-up. The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure) and patient-related composite events up to 3-year follow-up were compared in crude and propensity score-matched analyses. Of 5,054 patients, 3,830 patients (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (189 [6.2%] vs 127 [6.4%], p = 0.812) and the patient-related outcome (420 [13.7%] vs 250 [12.5%], p = 0.581) did not differ between EES and ZES-R, respectively, at 3 years, which was corroborated by similar results from the propensity score-matched cohort (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.70 to 1.20, p = 0.523 and 0.85, 95% CI 0.70 to 1.02, p = 0.081, for stent- and patient-related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs 10 [0.5%], p = 0.370) was also similar. The rate of very late definite or probable stent thrombosis was very low and comparable between the 2 stents (3 [0.1%] vs 1 [0.1%], p = 0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440 to 5.354, p stents showed comparable safety and efficacy at 3-year follow-up in this robust real-world registry with unrestricted use of EES and

  5. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V)

    DEFF Research Database (Denmark)

    Christiansen, Evald Høj; Jensen, Lisette Okkels; Thayssen, Per

    2013-01-01

    Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer......-coated sirolimus-eluting stent in a population-based setting....

  6. Stent Coating Integrity of Durable and Biodegradable Coated Drug Eluting Stents.

    Science.gov (United States)

    Yazdani, Saami K; Sheehy, Alexander; Pacetti, Stephen; Rittlemeyer, Brandon; Kolodgie, Frank D; Virmani, Renu

    2016-10-01

    Coatings consisting of a polymer and drug are widely used in drug-eluting stents (DES) and are essential in providing programmable drug release kinetics. Among other factors, stent coating technologies can influence blood compatibility, affect acute and sub-acute healing, and potentially trigger a chronic inflammatory response. The aim of this study was to investigate the short-term (7 and 28 days) and long-term (90 and 180 days) coating integrity of the Xience Prime Everolimus-Eluting Stent (EES), Resolute Zotarolimus-Eluting Stent (ZES), Taxus Paclitaxel-Eluting Stent (PES), and Nobori Biolimus A9-Eluting Stent (BES) in a rabbit ilio-femoral stent model. Stented arteries (n = 48) were harvested and the tissue surrounding the implanted stents digested away with an enzymatic solution. Results demonstrated that the majority of struts of EES were without any coating defects with a few struts showing minor defects. Similarly, for the ZES, most of the struts were without coating defects at all time points except at 180 days. The majority of PES demonstrated mostly webbing and uneven coating. In the BES group, the majority of strut coating showed polymer cracking. Overall, the EES and ZES had fewer coating defects than the PES and BES. Coating defects, however increase over time for the ZES, whereas the percent of coating irregularities remained constant for the EES. These results provide, for the first time, a comparison of the long-term durability of these drug-eluting stent coatings in vivo. © 2016, Wiley Periodicals, Inc.

  7. Stent-in-Stent Technique for the Treatment of Proximal Bronchial Restenosis after Insertion of Metallic Stents: A Report of Two Cases

    Directory of Open Access Journals (Sweden)

    Benjamin Bondue

    2016-01-01

    Full Text Available Endoscopic treatment of a bronchial restenosis previously treated by insertion of a partially covered self-expandable metallic stent (SEMS can be difficult. Classically, after recanalization of the bronchus, the stent is removed and replaced by a more adapted one. We report on two cases of proximal bronchial restenosis treated by insertion of an additional stent inside the lumen of the previously inserted stent using the stent-in-stent (SIS technique. The indications for the initial stent were malignancy in Patient 1 and posttransplant bronchial stenosis in Patient 2. Restenosis occurred at the proximal end of the stent within months in both cases. Stent removal and insertion of a new stent were considered, but this option was discarded because of an excessive risk of bronchial perforation and preference towards an alternative approach. In both cases, a second customized SEMS was placed using the SIS technique after ablation of the proximal end stenosis of the stent by argon plasma coagulation and/or dilation with a balloon. Recanalization of the bronchus was achieved in both cases without complications. The SIS technique is a valuable alternative to removal of SEMS in case of proximal bronchial restenosis.

  8. Study on the application of big cup membranate stent on restenosis after stenting for carcinoma of esophago cardia

    International Nuclear Information System (INIS)

    Wang Xiuping; Yao Zhongqiang; Liu Jian; Zhang Yan

    2007-01-01

    Objective: To evaluate the clinical value of self-designed big cup membranate stent on restenosis after stenting for carcinoma of esophago-cardia. Methods: 12 cases of restenosis after stenting for carcinoma of esophago-cardia were involved in the study. Self-designed big cup membranate stent made by Nanjing Weichuang Company (the length of the cup was 3.5 cm)was placed into the constricted stent under guidance of fluoroscopy. Clinical effect, restenosis, and complications were observed during followed up. Results: All the 12 cases of big cup membranat stent placement went along smoothly without indigitation of the cup of the stent. Follow-up of 1.5-8 months showed that 2 cases developed severe restenosis on the big cup of the stem, resulting in third grade difficult deglutition. Among them, one occurred 1 month after stenting, caused by hyperplasia of large amount of granulation tissue; another occurred 6 months after stenting, caused by growth of tumor tissue. 3 cases developed mild to moderate restenosis, 2.3-7 months (mean: 4.6 months) after stenting, with result of first grade difficult deglutition. The remaining 7 cases (mean 5.6 months follow-up) did not have difficulty during deglutition. Conclusions: Application of big cup membranate stent on restenosis after stenting for carcinoma of esophago-cardia can effectively prevent the stent from moving downwards and thus lower down the rate of restenosis, and postpone the occurrence of restenosis. (authors)

  9. [Cost-effectiveness trial of self-expandable metal stents and plastic biliary stents in malignant biliary obstruction].

    Science.gov (United States)

    Daróczi, Tímea; Bor, Renáta; Fábián, Anna; Szabó, Ella; Farkas, Klaudia; Bálint, Anita; Czakó, László; Rutka, Mariann; Szűcs, Mónika; Milassin, Ágnes; Molnár, Tamás; Szepes, Zoltán

    2016-02-14

    Self-expandable metal and plastic stents can be applied in the palliative endoscopic treatment of patients with unresectable malignant biliary obstruction. The use of metal stentsis recommended if the patient's life expectancy is more than four months. To compare the therapeutic efficacy and cost-effectiveness of metal and plastic stents in the treatment of malignant biliary obstruction. The authors retrospectively enrolled patients who received metal (37 patients) or plastic stent (37 patients). The complication rate, stent patency and cumulative cost of treatment were assessed in the two groups. The complication rate of metal stents was lower (37.84% vs. 56.76%), but the stent patency was higher compared with plastic stents (19.11 vs. 8.29 weeks; p = 0.0041). In the plastic stent group the frequency of hospitalization of patients in context with stent complications (1.18 vs. 2.32; p = 0.05) and the necessity of reintervention for stent dysfunction (17 vs. 27; p = 0.033) were substantially higher. In this group multiple stent implantation raised the stent patency from 7.68 to 10.75 weeks. There was no difference in the total cost of treatment of malignant biliary obstruction between the two groups (p = 0.848). Considering the cost of treatment and the burden of patients the authors recommend self-expandable metal sten timplantation if the life expectancy of patients is more than two months. In short survival cases multiple plastic stent implantation is recommended.

  10. Very late bare-metal stent thrombosis, rare but stormy!

    LENUS (Irish Health Repository)

    Ali, Mohammed

    2011-08-01

    Recurrent in-stent thrombosis is rarely reported, with catastrophic clinical consequences of either acute coronary syndrome or death. We present a case of recurrent in-stent thrombosis with its outcome and a concise literature review.

  11. Forgotten ureteral stents: Risk factors, complications and management

    African Journals Online (AJOL)

    A.Y. Abdelaziz

    2018-02-07

    Feb 7, 2018 ... Preoperative non-contrast spiral CT abdomen and pelvis showed encrustations on the stent in 23.5% of patients ... Despite their advantages, ureteral stents are not without possible morbidity. ..... A model to quantify encrusta-.

  12. Successful Expansion of an Underexpanded Stent by Rotational Atherectomy

    Science.gov (United States)

    Vales, Lori; Coppola, John; Kwan, Tak

    2013-01-01

    The current routine use of intracoronary stents in percutaneous coronary intervention (PCI) has significantly reduced rates of restenosis, compared with balloon angioplasty alone. On the contrary, small post-stenting luminal dimensions due to undilatable, heavily calcified plaques have repeatedly been shown to significantly increase the rates of in-stent restenosis. Rotational atherectomy of lesions is an alternative method to facilitate PCI and prevent underexpansion of stents, when balloon angioplasty fails to successfully dilate a lesion. Stentablation, using rotational atherectomy to expand underexpanded stents deployed in heavily calcified plaques, has also been reported. We report a case via the transradial approach of rotational-atherectomy–facilitated PCI of in-stent restenosis of a severely underexpanded stent due to a heavily calcified plaque. We review the literature and suggest rotational atherectomy may have a role in treating a refractory, severely underexpanded stent caused by a heavily calcified plaque through various proposed mechanisms. PMID:24436587

  13. Hemodynamic comparison of stent configurations used for aortoiliac occlusive disease

    NARCIS (Netherlands)

    Groot Jebbink, Erik; Mathai, Varghese; Boersen, Johannes Thomas; Sun, Chao; Slump, Cornelis H.; Goverde, Peter C.J.M.; Versluis, Michel; Reijnen, Michel M.P.J.

    Background Endovascular treatment of aortoiliac occlusive disease entails the use of multiple stents to reconstruct the aortic bifurcation. Different configurations have been applied and geometric variations exist, as quantified in previous work. Other studies concluded that specific stent geometry

  14. Technological Advances in Stent Therapies: a Year in Review.

    Science.gov (United States)

    Raffoul, Jad; Nasir, Ammar; Klein, Andrew J P

    2018-04-07

    Stent technology has rapidly evolved since the first stainless steel bare metal stents with substantial developments in scaffolding, polymer, drug choice, drug delivery, and elution mechanisms. Most recently, there has been the evolution of bioabsorbable vascular scaffolds, potentially eliminating the need for long-term foreign object retention. These rapid developments have led to an ever-expanding selection of new stents, making the choice of which to use in which patient challenging. Operators must balance potential short- and long-term clinical ramifications, namely stent thrombosis, in-stent restenosis, target lesion revascularization, and target lesion failure. In this review, we hope to provide insight for interventional cardiologists on the details of stent technology and how this impacts outcomes, stent selection, and duration of dual-antiplatelet therapy duration post drug-eluting stent implantation.

  15. New nonabsorbable stent versus a microsurgical procedure for vasectomy reversal: evaluating tissue reactions at the anastomosis in rabbits

    NARCIS (Netherlands)

    Vrijhof, Eric J.; de Bruine, Adriaan; Zwinderman, Aeilko; Lycklama à Nijeholt, August A. B.; Koole, Leo

    2005-01-01

    To investigate whether a newly designed nonabsorbable polymeric stent for the reconstruction of the vas deferens provided less stricturing at the site of the anastomosis in comparison with the conventional microsurgical reconstruction of the vas deferens. Prospective randomized study in 26 rabbits,

  16. Stent placement or brachytherapy for palliation of dysphagia from esophageal cancer: a prognostic model to guide treatment selection

    NARCIS (Netherlands)

    Steyerberg, Ewout W.; Homs, Marjolein Y. V.; Stokvis, Annemieke; Essink-Bot, Marie-Louise; Siersema, Peter D.

    2005-01-01

    BACKGROUND: Brachytherapy was found to be preferable to metal stent placement for the palliation of dysphagia because of inoperable esophageal cancer in the randomized SIREC trial. The benefit of brachytherapy, however, only occurred after a relatively long survival. The objective is to develop a

  17. Metallic Stents for Tracheobronchial Pathology Treatment

    International Nuclear Information System (INIS)

    Serrano, Carolina; Laborda, Alicia; Lozano, Juan M.; Caballero, Hugo; Sebastián, Antonio; Lopera, Jorge; Gregorio, Miguel Ángel de

    2013-01-01

    Purpose: To present the 7-year experience of the treatment of benign and malignant tracheobronchial stenoses using metallic stents. Patients and Methods: One hundred twenty-three stents were inserted in 86 patients (74 benign and 12 malignant stenoses). Ninety-seven stents were placed in the trachea and 26 in the bronchi. The procedures were performed under fluoroscopic and flexible bronchoscopic guidance with the patient under light sedation. In cases of severe stenotic lesions or obstructions, laser resection was performed before stent placement. Clinical and functional pulmonary data were recorded before and 3 months after the procedure. Follow-up involved clinical data and radiographic techniques at 48 h and at 1-, 3-, 6-, and 12-month intervals. Results: The technical success was 100 %. Dyspnea disappearance, forced expiratory volume in the first second, and pulmonary functional data improvement was observed in all patients (p < 0.001). Complications were detected in 23 patients (26.7 %). Mean follow-up time was 6.3 ± 1.2 months in patients with malignant lesions and 76.2 ± 2.3 months patients with in benign lesions. By the end of the study, 100 % of patients with malignant pathology and 6.7 % of patients with benign lesions had died. Conclusion: Endoluminal treatment of tracheobronchial stenosis with metallic stents is a therapeutic alternative in patients who are poor candidates for surgery. In unresectable malignant lesions, the benefit of metallic stenting is unquestionable. In benign lesions, the results are satisfactory, but sometimes other interventions are required to treat complications. New stent technology may improve these results

  18. Metallic stents for tracheobronchial pathology treatment.

    Science.gov (United States)

    Serrano, Carolina; Laborda, Alicia; Lozano, Juan M; Caballero, Hugo; Sebastián, Antonio; Lopera, Jorge; de Gregorio, Miguel Ángel

    2013-12-01

    To present the 7-year experience of the treatment of benign and malignant tracheobronchial stenoses using metallic stents. One hundred twenty-three stents were inserted in 86 patients (74 benign and 12 malignant stenoses). Ninety-seven stents were placed in the trachea and 26 in the bronchi. The procedures were performed under fluoroscopic and flexible bronchoscopic guidance with the patient under light sedation. In cases of severe stenotic lesions or obstructions, laser resection was performed before stent placement. Clinical and functional pulmonary data were recorded before and 3 months after the procedure. Follow-up involved clinical data and radiographic techniques at 48 h and at 1-, 3-, 6-, and 12-month intervals. The technical success was 100 %. Dyspnea disappearance, forced expiratory volume in the first second, and pulmonary functional data improvement was observed in all patients (p < 0.001). Complications were detected in 23 patients (26.7 %). Mean follow-up time was 6.3 ± 1.2 months in patients with malignant lesions and 76.2 ± 2.3 months patients with in benign lesions. By the end of the study, 100 % of patients with malignant pathology and 6.7 % of patients with benign lesions had died. Endoluminal treatment of tracheobronchial stenosis with metallic stents is a therapeutic alternative in patients who are poor candidates for surgery. In unresectable malignant lesions, the benefit of metallic stenting is unquestionable. In benign lesions, the results are satisfactory, but sometimes other interventions are required to treat complications. New stent technology may improve these results.

  19. Metallic Stents for Tracheobronchial Pathology Treatment

    Energy Technology Data Exchange (ETDEWEB)

    Serrano, Carolina, E-mail: carolina.serrano@unizar.es [University of Zaragoza, Surgical Pathology Unit, Animal Pathology Department (Spain); Laborda, Alicia, E-mail: alaborda@unizar.es [University of Zaragoza, Minimally Invasive Techniques Research Group (GITMI) (Spain); Lozano, Juan M., E-mail: juamauloz@gmail.com [Marly Clinic, Radiology Department (Colombia); Caballero, Hugo, E-mail: hugocaballero2007@gmail.com [Marly Clinic, Pulmonology Department (Colombia); Sebastian, Antonio, E-mail: antonio.sebastian@ono.es [Lozano Blesa Clinical University Hospital, Pulmonology Department (Spain); Lopera, Jorge, E-mail: lopera@uthscsa.edu [Health Science Center, Interventional Radiology Deparment (United States); Gregorio, Miguel Angel de, E-mail: mgregori@unizar.es [University of Zaragoza, Minimally Invasive Techniques Research Group (GITMI) (Spain)

    2013-12-15

    Purpose: To present the 7-year experience of the treatment of benign and malignant tracheobronchial stenoses using metallic stents. Patients and Methods: One hundred twenty-three stents were inserted in 86 patients (74 benign and 12 malignant stenoses). Ninety-seven stents were placed in the trachea and 26 in the bronchi. The procedures were performed under fluoroscopic and flexible bronchoscopic guidance with the patient under light sedation. In cases of severe stenotic lesions or obstructions, laser resection was performed before stent placement. Clinical and functional pulmonary data were recorded before and 3 months after the procedure. Follow-up involved clinical data and radiographic techniques at 48 h and at 1-, 3-, 6-, and 12-month intervals. Results: The technical success was 100 %. Dyspnea disappearance, forced expiratory volume in the first second, and pulmonary functional data improvement was observed in all patients (p < 0.001). Complications were detected in 23 patients (26.7 %). Mean follow-up time was 6.3 {+-} 1.2 months in patients with malignant lesions and 76.2 {+-} 2.3 months patients with in benign lesions. By the end of the study, 100 % of patients with malignant pathology and 6.7 % of patients with benign lesions had died. Conclusion: Endoluminal treatment of tracheobronchial stenosis with metallic stents is a therapeutic alternative in patients who are poor candidates for surgery. In unresectable malignant lesions, the benefit of metallic stenting is unquestionable. In benign lesions, the results are satisfactory, but sometimes other interventions are required to treat complications. New stent technology may improve these results.

  20. Broken Esophageal Stent Successfully Treated by Interventional Radiology Technique

    International Nuclear Information System (INIS)

    Zelenak, Kamil; Mistuna, Dusan; Lucan, Jaroslav; Polacek, Hubert

    2010-01-01

    Esophageal stent fractures occur quite rarely. A 61-year-old male patient was previously treated for rupture of benign stenosis, occurring after dilatation, by implanting an esophageal stent. However, a year after implantation, the patient suffered from dysphagia caused by the broken esophageal stent. He was treated with the interventional radiology technique, whereby a second implantation of the esophageal stent was carried out quite successfully.

  1. Risk of stent thrombosis among bare-metal stents, first-generation drug-eluting stents, and second-generation drug-eluting stents: results from a registry of 18,334 patients.

    Science.gov (United States)

    Tada, Tomohisa; Byrne, Robert A; Simunovic, Iva; King, Lamin A; Cassese, Salvatore; Joner, Michael; Fusaro, Massimiliano; Schneider, Simon; Schulz, Stefanie; Ibrahim, Tareq; Ott, Ilka; Massberg, Steffen; Laugwitz, Karl-Ludwig; Kastrati, Adnan

    2013-12-01

    This study sought to compare the risk of stent thrombosis among patients treated with bare-metal stents (BMS), first-generation drug-eluting stents (G1-DES), and second-generation drug-eluting stents (G2-DES) for a period of 3 years. In patients undergoing coronary stenting, there is a scarcity of long-term follow-up data on cohorts large enough to compare rates of stent thrombosis across the stent generations. A total of 18,334 patients undergoing successful coronary stent implantation from 1998 to 2011 at 2 centers in Munich, Germany, were included in this study. Patients were stratified into 3 groups according to treatment with BMS, G1-DES, and G2-DES. The cumulative incidence of definite stent thrombosis at 3 years was 1.5% with BMS, 2.2% with G1-DES, and 1.0% with G2-DES. On multivariate analysis, G1-DES compared with BMS showed a significantly higher risk of stent thrombosis (odds ratio [OR]: 2.05; 95% confidence interval [CI]: 1.47 to 2.86; p stent thrombosis compared with BMS (OR: 0.82; 95% CI: 0.56 to 1.19; p = 0.30). Beyond 1 year, the risk of stent thrombosis was significantly increased with G1-DES compared with BMS (OR: 4.72; 95% CI: 2.01 to 11.1; p stenting, compared with BMS, there was a significant excess risk of stent thrombosis at 3 years with G1-DES, driven by an increased risk of stent thrombosis events beyond 1 year. G2-DES were associated with a similar risk of stent thrombosis compared with BMS. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  2. Migrated esophageal stent posing a challenge for ventilation

    Directory of Open Access Journals (Sweden)

    Nita D'souza

    2017-01-01

    Full Text Available Self-expandable esophageal stents are being commonly used for palliative treatment in advanced esophageal cancer patients to relieve dysphagia, prevent tracheoesophageal fistula, and facilitate symptomatic betterment. The modern covered stents reduce the ingrowth of the tumor but have seen an increase in the incidence of stent migrations. We report a rather complicated presentation of an esophageal stent for esophageal dilatation and a challenging management of a difficult tracheostomy.

  3. Percutaneous common femoral artery interventions using angioplasty, atherectomy, and stenting.

    Science.gov (United States)

    Mehta, Manish; Zhou, Yi; Paty, Philip S K; Teymouri, Medhi; Jafree, Kamran; Bakhtawar, Humayun; Hnath, Jeffrey; Feustel, Paul

    2016-08-01

    This study evaluated the feasibility, safety, and effectiveness of endovascular interventions for common femoral artery (CFA) occlusive disease. Using a prospectively maintained multicenter database, we analyzed outcomes in 167 consecutive patients who underwent percutaneous CFA interventions for Rutherford class 3 to class 6 (R3-R6) disease. The standardized treatment approach included primary percutaneous transluminal angioplasty (PTA) only, atherectomy + PTA, and provisional stenting. Outcomes included technical failure rate, recurrence, complications, and major or minor amputation rate. Data were analyzed using multivariate regression analysis. During a 7-year period, 167 patients with R3 (n = 91 [54.5%]) and R4 to R6 (n = 76 [45.5%]) disease underwent CFA interventions that included PTA only (n = 114 [68.2%]), atherectomy ± PTA (n = 38 [22.8%]), and provisional stenting (n = 15 [9.0%]) for failed atherectomy ± PTA. Procedure-related complications included pseudoaneurysm (n = 1 [0.6%]), thrombosis (n = 1 [0.6%]), distal embolization (n = 1 [0.6%]), and death (R6, n = 1 [0.06%]). CFA restenosis was observed in 34 (20.4%) patents; these underwent further percutaneous (n = 18 [10.8%]) or surgical (n = 17 [10.2%]) revascularization that included CFA endarterectomy ± femoral distal bypass. Major or minor amputations were observed in none of the R3 patients and in only three (3.9%) and five (6.5%) of the R4 to R6 patients, respectively. Compared with the atherectomy + PTA group, patients in the PTA-only group had a significantly lower patency. Furthermore, during long-term mean follow-up of 42.5 months, the CFA provisional stent group had a 100% primary patency, which was significantly better than the primary patency in the CFA nonstent groups combined (77.0%; P = .0424). Data from this study to date would suggest that percutaneous CFA interventions in select patients are relatively safe and effective. In the long term, CFA stenting has

  4. Nasolacrimal Stenting: Toward Improving Outcomes with a Simple Modification of the Song Stent

    International Nuclear Information System (INIS)

    Lanciego, Carlos; Miguel, Silvia De; Padilla, Manuel; Perea, Miguel; Rodriguez-Merlo, Rufo; Garcia-Garcia, Lorenzo

    2006-01-01

    The purpose of this study was to evaluate, in a prospective, single-center study, the effectiveness of Song's polyurethane stents, modified 'in-house,' in the percutaneous management of epiphora. Patients (n = 170; age range 18-83, mean = 64; 50 male, 120 female) with severe epiphora had the modified stents inserted (183 eyes/195 stents) to treat unilateral/bilateral and complete/partial obstruction of the nasolacrimal system. The etiology of the obstruction was idiopathic in 119 cases (61%) and chronic dacryocystitis in 76 (39%). The set designed by Song was used in all patients but modified by us such that the extreme end is cone-shaped. The original technique was slightly modified by us and the procedure was conducted on an outpatient basis. The initial technical success rate of stent placement was 97%. Resolution of epiphora was complete in 180 eyes and partial in 3. On follow-up (mean = 18 months; range: 2 days to 24 months), 165 of 195 stents (85%) remained patent. Primary patency rates at follow-up were 86%, 84%, 84%, and 79% in the first 6 months, second and third 6 months, and the present (24 months), respectively. Stents became obstructed in 30 patients, but all but 2 were easily withdrawn and 20 of these patients remained asymptomatic for a mean of 14 months (secondary patency of 67%). Following stent removal, the withdrawn stent was replaced with a new stent in the same intervention on 14 occasions. In another six cases, patency was re-established without the need of a second stent. The procedure is simple and safe, both in stent insertion as well as in mechanical de-blocking and withdrawal when occluded. Success was >80 % in the short term (1-year follow-up). Stenting failure does not preclude other treatment because with the modification that we had introduced, the extreme end of the stent becomes more accessible to mechanical de-blocking, withdrawal, and relocation. The levels of primary and secondary patencies are promising and warrant more

  5. 2-year patient-related versus stent-related outcomes

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Christiansen, Evald Høj

    2012-01-01

    years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES......, and 1,384 patients were assigned to receive the SES. RESULTS: At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.......80). CONCLUSIONS: At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes. (Scandinavian Organization for Randomized Trials With Clinical Outcome IV [SORT OUT IV]; NCT00552877)....

  6. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial

    DEFF Research Database (Denmark)

    Kelbaek, H.; Klovgaard, L.; Helqvist, S.

    2008-01-01

    data of the long-term outcome of patients with complex coronary artery lesions. METHODS: We randomly assigned 322 patients with total coronary occlusions or lesions located in bifurcations, ostial, or angulated segments of the coronary arteries to have SES or BMS implanted. RESULTS: At 3 years, major...... performed between 1 and 3 years after the index treatment (p = NS). According to revised definitions, stent thrombosis occurred in 5 patients (3.1%) in the SES group and in 7 patients (4.4%) in the BMS group (p = NS); very late stent thrombosis was observed in 4 versus 1 patient. CONCLUSIONS: A continued...

  7. Temporary stenting and retrieval of the self-expandable, intracranial stent in acute middle cerebral artery occlusion

    Energy Technology Data Exchange (ETDEWEB)

    Suh, Sang Hyun; Chung, Tae-Sub [Yonsei University College of Medicine, Department of Radiology, Gangnam Severance Hospital, Seoul (Korea); Lee, Kyung-Yul [Yonsei University College of Medicine, Department of Neurology, Gangnam Severance Hospital, Seoul (Korea); Hong, Chang Ki; Kim, Chang-Hyun [Yonsei University College of Medicine, Department of Neurosurgery, Gangnam Severance Hospital, Seoul (Korea); Kim, Byung Moon; Kim, Dong Ik [Yonsei University College of Medicine, Department of Radiology, Seoul (Korea)

    2009-08-15

    We describe our experience in which a retrievable Enterprise stent was used as a temporary recanalization and embolectomy device in an acute middle cerebral artery (MCA) occlusion after urgent stenting for ipsilateral carotid artery stenosis. (orig.)

  8. Percutaneous transhepatic self-expanding metal stents for palliation ...

    African Journals Online (AJOL)

    Stent occlusion occurred in 4 patients (8%) within a week as result of stent migration (n=3) or presumed biliary sludge (n=1); 2 (4%) stents occluded between 7 days and 1 month. Four patients (8%) died during hospital admission due to pre-existing biliary sepsis (n=3) and pneumonia (n=1). Nine patients developed ...

  9. Modelling and simulating in-stent restenosis with complex automata

    NARCIS (Netherlands)

    Hoekstra, A.G.; Lawford, P.; Hose, R.

    2010-01-01

    In-stent restenosis, the maladaptive response of a blood vessel to injury caused by the deployment of a stent, is a multiscale system involving a large number of biological and physical processes. We describe a Complex Automata Model for in-stent restenosis, coupling bulk flow, drug diffusion, and

  10. Covered Balloon-Expanding Stents in Airway Stenosis.

    Science.gov (United States)

    Majid, Adnan; Kheir, Fayez; Chung, Jey; Alape, Daniel; Husta, Bryan; Oh, Scott; Folch, Erik

    2017-04-01

    The balloon-expanding stents are widely available but rarely described for use within the tracheobronchial tree. This report describes our experience with these stents in airway stenosis particularly as a lobar salvage therapy. This was a retrospective review of all records in which the balloon-expanding stents were used at a tertiary medical center. Ages, sex, location of stenosis, etiology of stenosis, stent size, duration of stent placement and associated interventions for airway stenosis were recorded. Patient's self-reported respiratory symptoms, dyspnea scale, and radiographic imaging at baseline and after stent placement were also reported. Twenty-one Atrium iCAST stents were inserted in 18 patients with malignant and benign airway disease. The median age was 69.5 years (interquartile range, 53.5 to 74). Most stents (n=20, 95%) were deployed in the lobar airways. There was a significant improvement in the modified Medical Research Council dyspnea scale from median of 3 to 2 (Pstent placement was achieved in 15 patients (83%). No deaths were related to airway stenting complications. Adverse events related to stents included migration (n=2, 9.5%), granulation tissue formation (n=2, 9.5%) and mucus plugging (n=1, 4.8%). Lobar stenting with balloon-expanding metallic stents appears feasible, safe and improves symptoms as well as radiographic atelectasis in patients with lobar airway stenosis in this small case series. Larger studies are needed to confirm this observation and to address long-term safety.

  11. A scanning electron microscopic study of biliary stent materials

    NARCIS (Netherlands)

    van Berkel, A. M.; van Marle, J.; van Veen, H.; Groen, A. K.; Huibregtse, K.

    2000-01-01

    Clogging of biliary stents remains an important problem. In vitro studies have shown less sludge formation in Teflon stents. Recently, clinical studies with Teflon stents have produced contradictory results. The aim of this study was to investigate whether the surface properties of the

  12. New techniques for stenting severely strictured or occluded ureters

    Energy Technology Data Exchange (ETDEWEB)

    Mygind, T; Dorph, S; Nielsen, H; Nielsen, L

    1985-11-01

    Percutaneous stenting of the severely strictured ureter is facilitated by catheterization through a rigid curved tube leading through the kidney. Alternatively, bidirectional traction tensioning of a guide wire pulled through the entire urinary tract permits antegrade dilatation and stent drainage. Complete occlusion near the ureteric orifice may be bypassed by transureteral puncture of the bladder followed by stent insertion.

  13. Mechanical Behavior of Fully Expanded Commercially Available Endovascular Coronary Stents

    OpenAIRE

    Tambaca, Josip; Canic, Suncica; Kosor, Mate; Fish, R. David; Paniagua, David

    2011-01-01

    The mechanical behavior of endovascular coronary stents influences their therapeutic efficacy. Through computational studies, researchers can analyze device performance and improve designs. We developed a 1-dimensional finite element method, net-based algorithm and used it to analyze the effects of radial loading and bending in commercially available stents. Our computational study included designs modeled on the Express, Cypher, Xience, and Palmaz stents.

  14. Malignant biliary obstruction: percutaneous use of self-expandable stents

    NARCIS (Netherlands)

    Laméris, J. S.; Stoker, J.; Nijs, H. G.; Zonderland, H. M.; Terpstra, O. T.; van Blankenstein, M.; Schütte, H. E.

    1991-01-01

    A total of 83 self-expandable metallic stents were placed percutaneously in 69 patients for palliation of malignant biliary obstruction. Stent diameter was 1 cm; length, 3.5-10.5 cm. Of the 41 patients with common bile duct obstruction, 27 died 0.2-12 months (median, 3.2 months) after stent

  15. Welded tracheal stent removal in a child under cardiopulmonary bypass.

    Science.gov (United States)

    Kao, S C; Chang, W K; Pong, M W; Cheng, K W; Chan, K H; Tsai, S K

    2003-08-01

    Metallic tracheal stents have been used in the treatment of paediatric tracheomalacia for more than a decade. We describe a case in which critical airway obstruction occurred during removal of a welded tracheal stent using a rigid bronchoscope under general anaesthesia. Life-saving cardiopulmonary bypass was instituted urgently, and the welded stent was then removed successfully by directly opening the trachea.

  16. Role of Montgomery T-tube stent for laryngotracheal stenosis.

    Science.gov (United States)

    Prasanna Kumar, Saravanam; Ravikumar, Arunachalam; Senthil, Kannan; Somu, Lakshman; Nazrin, Mohd Ismail

    2014-04-01

    To identify the indications, complications and outcome of patients of LTS managed with Montgomery T-tube stenting and review the current literature about the role of stenting in LTS. Retrospective chart reviews of 39 patients of laryngotracheal stenosis managed by T-tube stenting for temporary or definitive treatment during the period 2004-2011 were considered. The data on indications for stenting, type of stent, problems/complications of stenting, duration of stenting, additional intervention and outcome of management were collected, tabulated and analyzed. Of the 51 cases of laryngotracheal stenosis 39 patients were treated by Montgomery T-tube stenting. There was no mortality associated with the procedure or stenting. 82% of the patients were successfully decannulated. The problems and complications encountered were crusting within the tube in 44% and granulation at the subglottis in 33%. Two patients had complication due to T-tube itself: One patient developed tracheomalacia and the other had stenosis at both ends of the T-tube. Stenting still has a role in management of inoperable or in some deadlock situations where resection anastomosis is not feasible. It is easier to introduce the stent and to maintain it. Complications are minor and can be managed easily. It is safe for long term use. We emphasize that the treating surgeon needs to use prudence while treating stenosis using stents. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  17. Long-term follow-up of young patients undergone coronary stenting

    International Nuclear Information System (INIS)

    Zhang Qi; Shen Weifeng; Zhang Jiansheng; Zhang Ruiyan; Hu Jian; Zhang Xian

    2004-01-01

    Objective: To evaluate the long-term effect of coronary stenting in young coronary artery diseased patients ( 45) undergoing coronary stenting were chosen randomly as the control group. Comparison the general characteristics, coronary angiographies, interventional and follow-up information between the two groups was undertaken. Results: Comparing with the control group, the young group patients presented much more myocardial infarctions (68% vs 35%, P<0.05) and single-vessel disease (83% vs 57%, P=0.001). Complete revascularization was achieved in 95% patients in the young group (95% vs control 78%, P=0.004). With a mean 67 ± 9 months follow-up, recurrent angina and readmission rate were higher in the young group, as well as the incidence of MACE. Repeat CAG revealed much more de novo lesions in the young group (44% vs 11%, P=0.02) and higher rate of re-stenting. Conclusions: Due to the high rate of complete circulatory reconstruction in young patients, the postprocedural events are probably caused by new coronary arterial lesions; therefore coronary stenting should be regarded as the primary choice of treatment. (authors)

  18. Operable malignant jaundice: To stent or not to stent before the operation?

    Science.gov (United States)

    Rerknimitr, Rungsun; Kullavanijaya, Pinit

    2010-01-16

    Traditionally, pre-operative biliary drainage (PBD) was believed to improve multi-organ dysfunction, and for this reason, was practiced worldwide. Over the last decade, this concept was challenged by many reports, including meta-analyses that showed no difference in morbidity and mortality between surgery with, and surgery without PBD, in operable malignant jaundice. The main disadvantages of PBD are seen to be the additional cost of the procedure itself, and the need for longer hospitalization. In addition, many studies showed the significance of specific complications resulting from PBD, such as recurrent jaundice, cholangitis, pancreatitis, cutaneous fistula, and bleeding. However, the results of these studies remain inconclusive as to date there has been no perfect study that equally randomized comparable patients according to the level of obstruction and technique used for PBD. Generally, endoscopic stent insertion (ES) is preferred for common duct obstruction, whereas endoscopic nasobiliary drainage and percutaneous biliary drainage is reserved for hilar obstruction, since ES in hilar block confers a high rate of cholangitis. Although, there is no guideline which either supports or refutes this approach, certain subgroups of patients, including those with symptomatic jaundice, cholangitis, impending renal failure, hilar block requiring preoperative portal vein embolization, and those who need pre-operative neoadjuvant therapy, are suitable candidates for PBD.

  19. Impact of stent strut design in metallic stents and biodegradable scaffolds.

    Science.gov (United States)

    Foin, Nicolas; Lee, Renick D; Torii, Ryo; Guitierrez-Chico, Juan Luis; Mattesini, Alessio; Nijjer, Sukhjinder; Sen, Sayan; Petraco, Ricardo; Davies, Justin E; Di Mario, Carlo; Joner, Michael; Virmani, Renu; Wong, Philip

    2014-12-20

    Advances in the understanding of healing mechanisms after stent implantation have led to the recognition of stent strut thickness as an essential factor affecting re-endothelialization and overall long term vessel healing response after Percutaneous Coronary Interventions (PCI). Emergence of Drug-eluting stents (DESs) with anti-proliferative coating has contributed to reducing the incidence of restenosis and Target Lesion Revascularization (TVR), while progress and innovations in stent materials have in the meantime facilitated the design of newer platforms with more conformability and thinner struts, producing lesser injury and improving integration into the vessel wall. Recent advances in biodegradable metal and polymer materials now also allow for the design of fully biodegradable platforms, which are aimed at scaffolding the vessel only temporarily to prevent recoil and constrictive remodeling of the vessel during the initial period required, and are then progressively resorbed thereby avoiding the drawback of leaving an unnecessary implant permanently in the vessel. The aim of this article is to review recent evolution in stent material and stent strut design while understanding their impact on PCI outcomes. The article describes the different metallic alloys and biodegradable material properties and how these have impacted the evolution of stent strut thickness and ultimately outcomes in patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  20. Invention of a nasolacrimal stent retrieval hook

    International Nuclear Information System (INIS)

    Kim, Tae Hyung; Kim, Yeong Kyun; Park, Sang Soo; Song, Ho Young

    1997-01-01

    To evaluate the clinical usefulness of a nasolacrimal stent retrieval hook The retrieval hook consisted of two parts, a hook and pusher. The head of the hook part was made of 0.7mm stainless steel wire and was question mark-shaped, while the body of this part was constructed by soldering together four stainless steel pipes ranging in thickness from 1.25 to 3.5mm, serially. The pusher part was made of two plastic tubes and was designed in such a way that the hook grasped the stent tightly. The device was used to remove 46 stents in 40 patients, and tested for 1) average number of trials;2) success rate;and 3) average time of the procedure. The average number of trials, success rate, and average time taken to remove the stent was 4.7, 91%, and 1.8 minutes, respectively. In the removal of nasolacrimal stents, the retrieval hook was easy to use, useful and effective

  1. Biological effect of microengineered grooved stents on strut healing: a randomised OCT-based comparative study in humans

    Science.gov (United States)

    Vesga, Boris; Hernandez, Hector; Higuera, Sergio; Gasior, Pawel; Echeveri, Dario; Delgado, Juan A; Dager, Antonio; Arana, Camilo; Simonton, Charles; Maehara, Akiko; Palmaz, Julio; Granada, Juan F

    2017-01-01

    Objective To evaluate the biological effect of microengineered stent grooves (MSG) on early strut healing in humans by performing optical coherence tomography (OCT) analysis 3 weeks following the implantation. Background In the experimental setting, MSG accelerate endothelial cell migration and reduce neointimal proliferation compared with bare metal stent (BMS). Methods A total of 37 patients undergoing percutaneous coronary intervention with de novo coronary lesions were randomly assigned to either MSG (n=19) or an identical BMS controls (n=18). All patients underwent OCT imaging at 3 weeks. A total of 7959 struts were included in the final analysis. Results At 3 weeks following stent implantation, almost all struts analysed (~97%) had evidence of tissue coverage. The percentage of partially covered struts was comparable between both groups. However, the percentage of fully embedded struts was higher in the BMS group (81.22%, 49.75–95.52) compared with the MSG group (74.21%, 58.85–86.38). The stent-level analysis demonstrated reduction in neointimal formation (neointimal hyperplasia area and volume reduction of ~14% and ~19%, respectively) in the MSG versus the BMS group. In the strut-level analysis, an even greater reduction (~22% in neointimal thickness) was seen in the MSG group. Layered neointimal was present in ~6% of the OCT frames in the BMS group while it was not present in the MSG group. Conclusions MSG induced a more homogeneous and predictable pattern of surface healing in the early stages following stent implantation. The biological effect of MSG on stent healing has the potential to improve the safety profile of current generation drug-eluting stents. Classifications BMS, OCT, clinical trials. PMID:28674616

  2. EFFECT OF STENT ABSORBED c-myc ANTISENSE OLIGODEOXYNUCLEOTIDE ON SMOOTH MUSCLE CELLS APOPTOSIS IN RABBIT CAROTID ARTERY

    Institute of Scientific and Technical Information of China (English)

    张新霞; 崔长琮; 李江; 崔翰斌; 徐仓宝; 朱参战

    2002-01-01

    Objective To investigate the effect of gelatin coated Platinium-Iridium stent absorbed c-myc antisense oligodeoxynucleotide (ASODN) on smooth muscle cells apoptosis in a normal rabbit carotid arteries. Methods Gelatin coated Platinium-Iridium stents were implanted in the right carotid arteries of 32 rabbits under vision. Animals were randomly divided into control group and treated group receiving c-myc ASODN (n=16, respectively). On 7, 14, 30 and 90 days following the stenting procedure ,morphometry for caculation of neointimal area and mean neointimal thickness were performed.The expression of c-myc protein was detected by immunohistochemical method. Apoptotic smooth muscle cells was detected by terminal deoxynucleotidyl transferase mediated dUTP nick end labeling (TUNEL). Results At 7 and 14 days after stenting,there were no detectable apoptotic cells in both groups. The apoptotic cells occurred in the neointima 30 and 90 days after stenting, and the number of apoptotic cells at 30 days were less [4.50±1.29 vs 25.75±1.89 (number/0.1mm2)] than that at 90 days [13.50±1.91 vs 41.50±6.46 (number/0.1mm2)]. Meanwhile c-myc ASODN induced more apoptotic cells than the control group(P<0.0001). c-myc protein expression was weak positive or negative in treated group and positive in control group.Conclusion c-myc ASODN can induce smooth muscle cells apoptosis after stenting in normal rabbit carotid arteries,and it can be used to prevent in-stent restenosis.

  3. Self-expandable metal stent placement for the palliation of malignant gastroduodenal obstruction: experience in a large, single, UK centre

    Energy Technology Data Exchange (ETDEWEB)

    Lowe, A.S. [Department of Clinical Radiology, Bradford Royal Infirmary (United Kingdom)]. E-mail: andy.lowe@bradfordhospitals.nhs.uk; Beckett, C.G. [Department of Gastroenterology, Bradford Royal Infirmary (United Kingdom); Jowett, S. [Department of Gastroenterology, Bradford Royal Infirmary (United Kingdom); May, J. [Department of Surgery, Bradford Royal Infirmary (United Kingdom); Stephenson, S. [Department of Clinical Radiology, Bradford Royal Infirmary (United Kingdom); Scally, A. [School of Health Studies, Bradford (United Kingdom); Tam, E. [Department of Clinical Radiology, Bradford Royal Infirmary (United Kingdom); Kay, C.L. [Department of Clinical Radiology, Bradford Royal Infirmary (United Kingdom)

    2007-08-15

    Aim: To assess the technical success rate, and evaluate the clinical outcome, length of hospital stay, and cost of palliative gastro-duodenal stenting in a single-centre. Materials and methods: Eight-seven patients referred for insertion of a gastroduodenal stent between April 1999 and April 2004 were recruited to a non-randomized, before and after intervention study performed in a single centre. Demographic data, diagnosis and symptoms along with clinical and technical outcomes were recorded. Results: The technical success rate was 84/87 (96.6%), with inability to traverse the stricture in three patients. No immediate complications were demonstrated. There was marked improvement after stent placement with resolution of symptoms and commencement of dietary intake in 76 patients (87%). Stenting resulted in improved quality of life as reflected by an increase in Karnofsky score from 44/100, to 63/100 post-procedure. Late complications included perforation (n = 1), migration (n = 1) and stent occlusions due to tumour ingrowth/overgrowth (n = 7; mean 165 days). Mean survival was 107 days (range 0-411 days). Median hospital stay post-stent placement was 5.5 days (range 1-55 days) with a majority of patients (75%) discharged home. The mean cost of each treatment episode was Pounds 4146 ($7132 $US, Euro 6,028 EUROS). Conclusion: The present series confirms that combined endoscopic and radiological gastroduodenal stenting is a highly favourable treatment for patients with inoperable malignant gastric outlet obstruction. The results suggest that this minimally invasive procedure has a very high technical success rate, whilst at the same time providing excellent palliation of symptoms with improved quality of life in the majority of patients.

  4. Air cholangiography in endoscopic bilateral stent-in-stent placement of metallic stents for malignant hilar biliary obstruction.

    Science.gov (United States)

    Lee, Jae Min; Lee, Sang Hyub; Jang, Dong Kee; Chung, Kwang Hyun; Park, Jin Myung; Paik, Woo Hyun; Lee, Jun Kyu; Ryu, Ji Kon; Kim, Yong-Tae

    2016-03-01

    Although endoscopic bilateral stent-in-stent (SIS) placement of self-expandable metallic stents (SEMS) is one of the major palliative treatments for unresectable malignant hilar biliary obstruction, post-endoscopic retrograde cholangiopancreatography (ERCP) cholangitis can occur frequently due to inadequate drainage, especially after contrast injection into the biliary tree. The aim of this study is to evaluate the efficacy and safety of air cholangiography-assisted stenting. This study included 47 patients with malignant hilar biliary obstruction who underwent endoscopic bilateral SEMS placement using the SIS technique. They were divided into two groups, air (n = 23) or iodine contrast (n = 24) cholangiography. We retrospectively compared comprehensive clinical and laboratory data of both groups. There were no significant differences found between the two groups with respect to technical success (87% versus 87.5%, air versus contrast group, respectively), functional success (95% versus 95.2%), 30-day mortality (8.3% versus 8.7%) and stent patency. Post-ERCP adverse events occurred in 5 (21.7%) of the patients in the air group and 8 (33.3%) of the patients in the contrast group. Among these, the rate of cholangitis was significantly lower in the air group (4.8% versus 29.2%, p = 0.048). In multivariate analysis, air cholangiography, technical success and a shorter procedure time were significantly associated with a lower incidence of post-ERCP cholangitis. Air cholangiography-assisted stenting can be a safe and effective method for endoscopic bilateral SIS placement of SEMS in patients with malignant hilar biliary obstruction.

  5. Anchoring barbs and balloon expandable stents: what is the risk of perforation and failed stent deployment?

    Science.gov (United States)

    Bown, M J; Harrison, G J; How, T V; Brennan, J A; Fisher, R K; Vallabhaneni, S R; McWilliams, R G

    2012-09-01

    Balloon expandable stents may on occasion be deployed in close proximity to the anchoring barbs of endovascular grafts. The aim of this study was to determine the risk and effect of balloon perforation by anchoring barbs and to assess whether these risks are different if the balloon is protected by a covered stent mounted upon it. A bench-top model was developed to mimic the penetration of anchoring barbs into the lumen of medium sized blood vessels. The model allowed variation of angle and depth of vessel penetration. Both bare balloons and those with covered stents mounted upon them were tested in the model to determine whether there was a risk of perforation and which factors increased or decreased this risk. All combinations of barb angle and depth caused balloon perforation but this was most marked when the barb was placed perpendicular to the long axis of the balloon. When the deployment of covered stents was attempted balloon perforation occurred in some cases but full stent deployment was achieved in all cases where the perforation was in the portion of the balloon covered by the stent. The only situation in which stent deployment failed was where the barb was intentionally placed in the uncovered portion of the balloon. This resulted in only partial deployment of the stent. Balloon rupture is a distinct possibility when deploying balloon-expandable stents in close proximity to anchoring barbs. Care should be taken in this circumstance to ensure that the barb is well away from the uncovered portion of the balloon. Copyright © 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

  6. Intraluminal Radioactive Stent Compared with Covered Stent Alone for the Treatment of Malignant Esophageal Stricture

    International Nuclear Information System (INIS)

    Wang Zhongmin; Huang Xunbo; Cao Jun; Huang Gang; Chen Kemin; LIu Yu; Liu Fenju

    2012-01-01

    Objective: This study was designed to compare the clinical effectiveness of intraluminal radioactive stent loaded with iodine-125 seeds implantation versus covered stent alone insertion in patients with malignant esophageal stricture. Methods: We studied two groups of patients with malignant esophageal stricture. Group A comprised 28 patients (19 men and 9 women) who underwent intraluminal radioactive stent loaded with iodine-125 seeds implantation and were followed prospectively. Group B comprised 30 patients (18 men and 12 women) who had previously received covered stent alone insertion; these patients were evaluated retrospectively. There was no crossover between the two groups during follow-up. Informed consent was obtained from each patient, and our institutional review board approved the study. The dysphagia score, overall survival rates, complication rates, and reintervention rates were compared in the two groups. Results: There were no significant differences between the two groups in terms of baseline characteristics. Stent placement was technically successful and well tolerated in all patients. The dysphagia score was improved in both groups after stent placement. The median survival was significantly longer in group A than in group B: 11 versus 4.9 months, respectively (P < 0.001). The complications of chest pain, esophageal reflux, and stent migration was more frequent in group B, but this difference did not reach statistical significance. There was no statistical difference in reintervention between two groups. Conclusions: Intraluminal radioactive stent loaded with iodine-125 seeds implantation was a feasible and practical management in treating malignant esophageal stricture and was superior to covered stent alone insertion, as measured by survival.

  7. The impact of precise robotic lesion length measurement on stent length selection: ramifications for stent savings.

    Science.gov (United States)

    Campbell, Paul T; Kruse, Kevin R; Kroll, Christopher R; Patterson, Janet Y; Esposito, Michele J

    2015-09-01

    Coronary stent deployment outcomes can be negatively impacted by inaccurate lesion measurement and inappropriate stent length selection (SLS). We compared visual estimate of these parameters to those provided by the CorPath 200® Robotic PCI System. Sixty consecutive patients who underwent coronary stent placement utilizing the CorPath System were evaluated. The treating physician assessed orthogonal images and provided visual estimates of lesion length and SLS. The robotic system was then used for the same measures. SLS was considered to be accurate when visual estimate and robotic measures were in agreement. Visual estimate SLSs were considered to be "short" or "long" if they were below or above the robotic-selected stents, respectively. Only 35% (21/60) of visually estimated lesions resulted in accurate SLS, whereas 33% (20/60) and 32% (19/60) of the visually estimated SLSs were long and short, respectively. In 5 cases (8.3%), 1 less stent was placed based on the robotic lesion measurement being shorter than the visual estimate. Visual estimate assessment of lesion length and SLS is highly variable with 65% of the cases being inaccurately measured when compared to objective measures obtained from the robotic system. The 32% of the cases where lesions were visually estimated to be short represents cases that often require the use of extra stents after the full lesion is not covered by 1 stent [longitudinal geographic miss (LGM)]. Further, these data showed that the use of the robotic system prevented the use of extra stents in 8.3% of the cases. Measurement of lesions with robotic PCI may reduce measurement errors, need for extra stents, and LGM. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Initial experience with a new biodegradable airway stent in children: Is this the stent we were waiting for?

    Science.gov (United States)

    Antón-Pacheco, Juan L; Luna, Carmen; García, Enrique; López, María; Morante, Rocío; Tordable, Cristina; Palacios, Alba; de Miguel, Mónica; Benavent, Isabel; Gómez, Andrés

    2016-06-01

    To report our experience with a new type of biodegradable airway stent in the setting of severe tracheobronchial obstruction in children. We conducted a retrospective and prospective (since June 2014) study of pediatric patients with severe airway obstruction treated with biodegradable stents in our institution between 2012 and 2015. The following data were collected: demographics, indication for stenting, bronchoscopic findings, insertion technique complications, clinical outcome, stent related complications, re-stenting, and time of follow-up. Thirteen custom-made polydioxanone stents were placed in four infants (mean age, 4 months) with severe tracheobronchial obstruction: tracheomalacia (two patients), bronchomalacia (1), and diffuse tracheal stenosis (1). All the stents were bronchoscopically inserted uneventfully. Immediate and maintained clinical improvement was observed in every case. No major stent related complications have occurred and only mild or moderate granulation tissue was observed during surveillance bronchoscopy. Two patients required repeated stenting as expected. All the patients are alive and in a good respiratory condition with a follow-up ranging from 5 to 40 months. Biodegradable airway stents seem to be safe, effective, and cause fewer complications than other types of stents. They can be an alternative to the classic metallic or plastic stents for severe tracheal stenosis or malacia in small children. More experience is needed in order to establish the definite clinical criteria for their use in pediatric patients. Pediatr Pulmonol. 2016;51:607-612. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  9. Meta-analysis comparing efficacy and safety of first generation drug-eluting stents to bare-metal stents in patients with diabetes mellitus undergoing primary percutaneous coronary intervention

    DEFF Research Database (Denmark)

    De Luca, Giuseppe; Dirksen, Maurits T; Spaulding, Christian

    2013-01-01

    revascularization (hazard ratio 0.42, 95% confidence interval 0.29 to 0.59, p 1 year) with DES. In conclusion, this meta-analysis, based on individual patients' data from 11 randomized trials, showed that among patients with diabetes with STEMIs who undergo primary percutaneous coronary intervention, sirolimus...... with high rates of target vessel revascularization after bare-metal stent (BMS) implantation but also higher rates of ST after DES implantation. Therefore, the aim of this study was to perform a meta-analysis of individual patients' data to evaluate the long-term safety and effectiveness of DES compared......Several concerns have emerged regarding the higher risk for stent thrombosis (ST) after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Few data have been reported so far in patients with diabetes mellitus, which is associated...

  10. Intra- and interobserver reliability and intra-catheter reproducibility using frequency domain optical coherence tomography for the evaluation of morphometric stent parameters and qualitative assessment of stent strut coverage

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Thayssen, Per; Junker, Anders

    2015-01-01

    to investigate the intra- and interobserver reliability, as well as the intra-catheter reproducibility of quantitative FD-OCT-assessment of morphometric stent parameters and qualitative FD-OCT-evaluation of strut coverage in 10 randomly selected 6-month follow-up Nobori® biolimus-eluting stents (N-BESs). METHODS...... in another 10 N-BESs (219 CSAs and 1860 struts) were independently assessed by one of the analysts. RESULTS: The intraobserver variability with regard to relative difference of mean luminal area and mean stent area at the CSA-level was very low: 0.1%±1.4% and 0.5%±3.2%. Interobserver variability also proved...... (CI): 0.88-0.93, pstented coronary segments, and for qualitative assessment of strut coverage....

  11. Prospective Multicenter Study on the Challenges Inherent to Using Large Cell-Type Stents for Bilateral Stent-in-Stent Placement in Patients with Inoperable Malignant Hilar Biliary Obstruction.

    Science.gov (United States)

    Yang, Min Jae; Kim, Jin Hong; Hwang, Jae Chul; Yoo, Byung Moo; Lee, Sang Hyub; Ryu, Ji Kon; Kim, Yong-Tae; Woo, Sang Myung; Lee, Woo Jin; Jeong, Seok; Lee, Don Haeng

    2018-06-22

    Although endoscopic bilateral stent-in-stent placement is challenging, many recent studies have reported promising outcomes regarding technical success and endoscopic reintervention. This study aimed to evaluate the technical feasibility of stent-in-stent placement using large cell-type stents in patients with inoperable malignant hilar biliary obstruction. Forty-three patients with inoperable malignant hilar biliary obstruction from four academic centers were prospectively enrolled from March 2013 to June 2015. Bilateral stent-in-stent placement using two large cell-type stents was successfully performed in 88.4% of the patients (38/43). In four of the five cases with technical failure, the delivery sheath of the second stent became caught in the hook-cross-type vertex of the large cell of the first stent, and subsequent attempts to pass a guidewire and stent assembly through the mesh failed. Functional success was achieved in all cases with technical success. Stent occlusion occurred in 63.2% of patients (24/38), with a median patient survival of 300 days. The median stent patency was 198 days. The stent patency rate was 82.9%, 63.1%, and 32.1% at 3, 6, and 12 months, respectively. Endoscopic re-intervention was performed in 14 patients, whereas 10 underwent percutaneous drainage. Large cell-type stents for endoscopic bilateral stent-in-stent placement showed acceptable functional success and stent patency when technically successful. However, the technical difficulty associated with the entanglement of the second stent delivery sheath in the hook-cross-type vertex of the first stent may preclude large cell-type stents from being considered as a dedicated standard tool for stent-in-stent placement.

  12. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

    Directory of Open Access Journals (Sweden)

    Wehrenberg Scott

    2010-01-01

    Full Text Available Abstract Background Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods/Design The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1, single-blind, non-inferiority trial in subjects with lesion length ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length ≤20 mm and vessel diameter ≥2.25 mm to Discussion The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platform provide comparable safety and improved procedural performance compared to the previous generation Express stent. PERSEUS trial enrollment is complete and primary endpoint data are expected in 2010. PERSEUS Workhorse and Small Vessel are registered at http://www.clinicaltrials.gov, identification numbers NCT00484315 and NCT00489541.

  13. Magnetizable stent-grafts enable endothelial cell capture

    Energy Technology Data Exchange (ETDEWEB)

    Tefft, Brandon J. [Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (United States); Uthamaraj, Susheil [Division of Engineering, Mayo Clinic, Rochester, MN (United States); Harburn, J. Jonathan [School of Medicine, Pharmacy and Health, Durham University, Stockton-on-Tees (United Kingdom); Hlinomaz, Ota [Department of Cardioangiology, St. Anne' s University Hospital, Brno (Czech Republic); Lerman, Amir [Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (United States); Dragomir-Daescu, Dan [Department of Physiology and Biomedical Engineering, Mayo Clinic, Rochester, MN (United States); Sandhu, Gurpreet S., E-mail: sandhu.gurpreet@mayo.edu [Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (United States)

    2017-04-01

    Emerging nanotechnologies have enabled the use of magnetic forces to guide the movement of magnetically-labeled cells, drugs, and other therapeutic agents. Endothelial cells labeled with superparamagnetic iron oxide nanoparticles (SPION) have previously been captured on the surface of magnetizable 2205 duplex stainless steel stents in a porcine coronary implantation model. Recently, we have coated these stents with electrospun polyurethane nanofibers to fabricate prototype stent-grafts. Facilitated endothelialization may help improve the healing of arteries treated with stent-grafts, reduce the risk of thrombosis and restenosis, and enable small-caliber applications. When placed in a SPION-labeled endothelial cell suspension in the presence of an external magnetic field, magnetized stent-grafts successfully captured cells to the surface regions adjacent to the stent struts. Implantation within the coronary circulation of pigs (n=13) followed immediately by SPION-labeled autologous endothelial cell delivery resulted in widely patent devices with a thin, uniform neointima and no signs of thrombosis or inflammation at 7 days. Furthermore, the magnetized stent-grafts successfully captured and retained SPION-labeled endothelial cells to select regions adjacent to stent struts and between stent struts, whereas the non-magnetized control stent-grafts did not. Early results with these prototype devices are encouraging and further refinements will be necessary in order to achieve more uniform cell capture and complete endothelialization. Once optimized, this approach may lead to more rapid and complete healing of vascular stent-grafts with a concomitant improvement in long-term device performance. - Highlights: • Magnetic stent-grafts were made from 2205 steel stents and polyurethane nanofibers. • Stent-grafts remained patent and formed a thin and uniform neointima when implanted. • Stent-grafts captured endothelial cells labeled with magnetic nanoparticles.

  14. Stent placement for tracheal stenosis in patients with esophageal cancer

    International Nuclear Information System (INIS)

    Takagi, Keigo; Hata, Yoshinobu; Sasamoto, Shuichi; Takahashi, Shoji; Sato, Fumitomo; Tamaki, Kazuyoshi; Goto, Hidenori; Yuasa, Rena

    2011-01-01

    Tracheal invasion including tracheal bifurcation due to esophageal cancer can sometimes cause serious complications of the airway, but such cases sometimes improve quickly following chemoradiation treatment. The absolute indications for stent replacement in the airway for this disorder and the optimal choice of stent are herein discussed. Between 1992 and 2010, 28 patients with airway stenosis, including 7 patients with esophago-tracheal fistula, were treated by placement of various stents; namely, 12 patients received Dumon stents, 3 patients had Dynamic stents, 10 patients were given Ultraflex stents, while 3 other patients were treated without the use of stents. Severe dyspnea in the supine position was observed, which mainly originated from invasion to the membranous portion of the trachea. Airway patency was maintained after stent replacement, although the median survival time of such cases was only 4 months. Three patients with severe dyspnea who could lie in a supine position recovered after undergoing chemoradiation treatment without stent replacement. No cases of stent removal were observed after chemoradiation treatment. Chemoradiation treatment for esophageal cancer was found to be effective for the management of airway disturbances, and thus the absolute indications for stent replacement are restricted to patients who cannot lie in a supine position due to severe impairment of ventilation during radiation therapy, as well as patients presenting with tracheobroncho-esophageal fistula. Concerning stent selection, a metal stent should be the first choice for tracheal stenosis due to its ease of insertion, because there is no substantial difference between silicone and metal stents regarding the treatment of tracheal stenosis. However, it is important to note that a silicone Y stent is useful for the treatment of tracheal bifurcation. (author)

  15. Malignant duodenal obstructions: palliative treatment with covered expandable nitinol stent

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hyun Chul; Jung, Gyoo Sik; Lee, Sang Hee; Kim, Sung Min; Oh, Kyung Seung; Huh, Jin Do; Cho, Young Duk [College of Medicine, Kosin Univ, Pusan (Korea, Republic of); Song, Ho Young [College of Medicine, Ulsan Univ., Seoul (Korea, Republic of)

    2002-04-01

    To evaluate the feasibility and clinical effectiveness of using a polyurethane-covered expandable nitinol stent in the palliative treatment of malignant duodenal obstruction. Under fluoroscopic guidance, a polyurethane-covered expandable nitinol stent was placed in 12 consecutive patients with malignant duodenal obstructions. All presented with severe nausea and recurrent vomiting. The underlying causes of obstruction were duodenal carcinoma (n=4), pancreatic carcinoma (n=4), gall bladder carcinoma (n=2), distal CBD carcinoma (n=1), and uterine cervical carcinoma (n=1). The sites of obstruction were part I (n=1), part II (n=8), and III (n=3). Due to pre-existing jaundice, eight patients with part II obstructions underwent biliary decompression prior to stent placement. An introducer sheath with a 6-mm outer diameter and stents 16 mm in diameter were employed, and to place the stent, and after-loading technique was used. Stent placement was technically successful in ten patients, and no procedural complications occuured. In one of two patients in whom there was technical failure, and in whom the obstructions were located in part III, the stent was placed transgastrically. Stent migration occurred in one patient four days after the procedure, and treatment involved the palcement of a second, uncovered, nitinol stent. After stent placement, symptoms improved in all patients. During follow-up, obstructive symptoms due to stent stenosis (n=1), colonic obstruction (n=1), and multiple small bowel obstruction (n=1) recurred in three patients. Two of these were treated by placing additional stents in the duodenum and colon, respectively. One of the eight patients in whom a stent was placed in the second portion of the duodenum developed jaundice. The patients died a mean 14 (median, 9) weeks after stent placement. The placement of a polyurethane-covered expandable nitinol stent seems to be technically feasible, safe and effective for the palliative treatment of malignant

  16. Temporary urethral covered stent - third year of experience

    International Nuclear Information System (INIS)

    Stojanovis, V.; Maksimovis, H.; Markovis, B.; Markovis, Z.

    2006-01-01

    Full text: In October 2003, a new generation of urethral stents ALLIUM, produced in Israel, were used at the Department of Interventional Radiology, CCS, in 18 patients with chronic stricture of bulbar urethra. The indications for insertion were determined according to well-known and recognized therapeutical protocols. The stent is made of nitinol wire with polyurethane cover. It is inserted under local anesthesia by a special self-expandable system that may be fixed or flexible. The stents we used were 3-6 cm long and 28 Fr wide. Radioscopic-assisted insertion was performed over formerly placed metal guide. Prior to insertion, balloon-catheter dilatation of stricture matching the stent width was carried out. Pre-insertion urethrotomy was performed in one case. The insertion technique is simple, presupposing the knowledge of older generations of techniques of urethral dilatation and insertion of self-expandable stents. The follow-up of results was done according to a priori established protocol including the following: UCG, uroflowmetry and interview with patients. Due to stent migration, the 'stent over stent' technique was applied in one case, while reposition by balloon-catheter outward traction was performed in two cases of caudal migration. No irritative discomforts were reported in the first 4 months after stent dwelling. Uroflowmetric controls verified at least four times better results than before the insertion. Given it is the question of covered stent, there is no possibility of proliferative secondary lumen obstruction. On account of soft structure and conic shape of posterior part of stent, no lesions of the external urethral sphincter were manifested. The stent is simply withdrawn after 6 months by outward traction using the forceps at the time when the stent construction turns into soft and straight wire. The first clinical experiences are very favorable and ALLIUM stent may be expected to be the stent of choice for chronic bulbar strictures

  17. Mechanical characteristics of self-expandable metallic stents: in vitro study with three types of stress

    International Nuclear Information System (INIS)

    Lee, Byung Hee; Kim, Kie Hwan; Chin, Soo Yil

    1998-01-01

    To obtain objective and comparable data for mechanical characteristics of self-expandable metallic stents widely used in the treatment of biliary obstruction. The stents tested were the 6 and 8 mm-band Hanaro spiral stent, Gianturco-Rosch Z stent, Wallstent, Ultraflex stent, and Memotherm stent. Each was subjected to three types of load:point, area, and circular. We analyzed their mechanical characteristics (resistance force, expansile force, and elasticity) according to these three types of stress. With regard to point loads, the Memotherm stent showed the highest resistance force and expansile force. The 8 mm-band Hanaro stent showed the lowest resistance force and the Gianturco-Rosch Z stent and Ultraflex stent showed lower expansile force. With regard to area loads, the Ultraflex stent showed the highest resistance force. The 6 mm-band Hanaro stent, Gianturco-Rosch Z stent, and Ultraflex stent showed higher expansile force. The 8 mm-band Hanaro stent showed the lowest value in both resistance force and expansile force. For circular loads, the Memotherm stent showed the highest resistance force and the Ultraflex stent and Wallstent showed lower value. Under all types of stress, the Hanaro stent and Memotherm stent were completely elastic, and the Ultraflex stent and Wallstent showed a wide gap between resistance force and expansile force. In clinical practice, awareness of the mechanical characteristics of each stent might help in choosing the one which is most suitable, according to type of biliary obstruction. =20

  18. Mechanical characteristics of self-expandable metallic stents: in vitro study with three types of stress

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Byung Hee; Kim, Kie Hwan; Chin, Soo Yil [Korea Cancer Center Hospital, Seoul (Korea, Republic of)

    1998-09-01

    To obtain objective and comparable data for mechanical characteristics of self-expandable metallic stents widely used in the treatment of biliary obstruction. The stents tested were the 6 and 8 mm-band Hanaro spiral stent, Gianturco-Rosch Z stent, Wallstent, Ultraflex stent, and Memotherm stent. Each was subjected to three types of load:point, area, and circular. We analyzed their mechanical characteristics (resistance force, expansile force, and elasticity) according to these three types of stress. With regard to point loads, the Memotherm stent showed the highest resistance force and expansile force. The 8 mm-band Hanaro stent showed the lowest resistance force and the Gianturco-Rosch Z stent and Ultraflex stent showed lower expansile force. With regard to area loads, the Ultraflex stent showed the highest resistance force. The 6 mm-band Hanaro stent, Gianturco-Rosch Z stent, and Ultraflex stent showed higher expansile force. The 8 mm-band Hanaro stent showed the lowest value in both resistance force and expansile force. For circular loads, the Memotherm stent showed the highest resistance force and the Ultraflex stent and Wallstent showed lower value. Under all types of stress, the Hanaro stent and Memotherm stent were completely elastic, and the Ultraflex stent and Wallstent showed a wide gap between resistance force and expansile force. In clinical practice, awareness of the mechanical characteristics of each stent might help in choosing the one which is most suitable, according to type of biliary obstruction. =20.

  19. Stenting of the SFA - indications, techniques,

    International Nuclear Information System (INIS)

    Rieger, J.; Treitl, M.; Reiser, M.; Ruppert, V.

    2006-01-01

    Aggressive risk factor modification, change of eating habits, exercise programs, and forceful antiplatelet therapy are the most important tools for the treatment of PAOD in symptomatic patients suffering from intermittent claudication. There are however no guidelines for revascularization at this stage. Endovascular treatment has been increasingly utilized over the last decade and increasingly displaced vascular surgery. Amongst numerous endovascular techniques beside PTA, stents meanwhile play the most important role due to constant technical progress. Results regarding the rate of restenosis or patency rates still remain worse compared to other vascular beds. This paper gives a review over recent results, currently available stent techniques, and possible indications for the endovascular therapy of an artery, which has turned out to be the biggest ordeal for material and construction of stents. (orig.) [de

  20. Metallic stent and stereotactic conformal radiotherapy for hilar cholangiocarcinoma

    International Nuclear Information System (INIS)

    Li Yu; Wang Ning; Tian Qihe; Guo Zhanwen; Zhang Haibo; Song Liyan

    2005-01-01

    Objective: To evaluate the effect of metallic stent combined with stereotactic conformal radiotherapy (SCRT) for hilar cholangiocarcinoma. Methods: Fifty-four patients with hilar cholangiocarcinoma were analyzed, including 31 treated with stent plus stereotactic conformal radiotherapy (combined group) and 23 with metallic stent alone (control group). Results: The mean survival time of combined group was 11.1 ± 4.6 months, compared with 5.1 ± 2.8 months of the control group, giving a significant difference between the two groups (P<0.01). Conclusion: The combination of metallic stent and stereotactic conformal radiotherapy is more effective than metallic stent alone for unresectable hilar cholangiocarcinoma. (authors)

  1. Scintigraphic examinations after stent implantation in central airways

    International Nuclear Information System (INIS)

    Richter, W.S.; Kettner, B.I.; Munz, D.L.

    1998-01-01

    Endotracheal and endobronchial stent implantation has been developed as an effective treatment of benign and malignant airway stenosis and of tracheo- or bronchoesophageal fistulas. The selection of the stent type depends on the kind and site of disease. Chest X-ray and bronchoscopy are the procedures of choice for monitoring of stent position, structure, and function. However, with scintigraphic methods the effects of stent implantation on pulmonary ventilation and perfusion can be assessed non-invasively. The validation of the effect of a stent implantation on mucociliary and tussive clearance remains to be elucidated. (orig.) [de

  2. Complications of esophageal stenting after radiotherapy and brachytherapy

    Energy Technology Data Exchange (ETDEWEB)

    Yorozu, Atsunori; Dokiya, Takushi; Ogita, Mikio; Kutuki, Shoji; Oki, Yosuke [National Second Hospital of Tokyo (Japan)

    1997-11-01

    The purpose of our study was to evaluate safety and complications of stenting after radiotherapy and brachytherapy. Fifteen of 21 patients showed improvement of dysphagia by stenting. But 6 of 21 patients had perforation or massive bleeding relating to stents. The risk for perforation or hemorrhage appears to be even higher in patients who have previously undergone radical radiotherapy and brachytherapy within one month before stenting. Stenting at 6 months or more after radical radiotherapy seems to be an effective and safe method of long-lasting palliation for severe dysphagia with recurrent esophageal cancer. (author)

  3. Treatment Approaches to Urinary Stones Caused by Forgotten DJ Stents

    Directory of Open Access Journals (Sweden)

    Ergun Alma

    2015-03-01

    Full Text Available Ureteral DJ stents have been used widely for years in urology practice. With increased use, complications have been increased and forgotton stents have started to cause problems. The most common complications are early pain and irritative symptoms. Late complications are bacterial colonization and stone formation because of the biofilm covering the stents. Treatment for a forgotten stent varies on many factors, such as stent localization and stone formation. In this article, we aimed to discuss our clinic approach on two different cases in light to current literature. [Cukurova Med J 2015; 40(Suppl 1: 58-63

  4. In vitro stent lumen visualisation of various common and newly developed femoral artery stents using MR angiography at 1.5 and 3 tesla.

    Science.gov (United States)

    Syha, R; Ketelsen, D; Kaempf, M; Mangold, S; Sixt, S; Zeller, T; Springer, F; Schick, F; Claussen, C D; Brechtel, K

    2013-02-01

    To evaluate stent lumen assessment of various commonly used and newly developed stents for the superficial femoral artery (SFA) using MR angiography (MRA) at 1.5 and 3 T. Eleven nitinol stents and one cobalt-chromium stent were compared regarding stent lumen visualisation using a common three-dimensional MRA sequence. Maximum visible stent lumen width and contrast ratio were analysed in three representative slices for each stent type. A scoring system for lumen visualisation was applied. Nitinol stents showed significantly better performance than the cobalt chromium stent (P stent lumen ranged between 43.4 and 95.5 %, contrast ratio between 7.2 and 110.6 %. Regarding both field strengths, seven of the nitinol stents were classified as "suitable". Three nitinol stents were "limited", and one nitinol stent and the cobalt chromium stent were "not suitable". Intraluminal loss of signal and artefacts of most of the SFA stents do not markedly limit assessment of stent lumen by MRA at 1.5 and 3 T. MRA can thus be considered a valid technique for detection of relevant in-stent restenosis. Applied field strength does not strongly influence stent lumen assessment in general, but proper choice of field strength might be helpful.

  5. Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report From the COMPARE II Trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent).

    Science.gov (United States)

    Vlachojannis, Georgios J; Smits, Pieter C; Hofma, Sjoerd H; Togni, Mario; Vázquez, Nicolás; Valdés, Mariano; Voudris, Vassilis; Slagboom, Ton; Goy, Jean-Jaques; den Heijer, Peter; van der Ent, Martin

    2017-06-26

    This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention. Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce. The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization. Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17). The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights

  6. A prospective group sequential study evaluating a new type of fully covered self-expandable metal stent for the treatment of benign biliary strictures (with video).

    Science.gov (United States)

    Poley, Jan-Werner; Cahen, Djuna L; Metselaar, Herold J; van Buuren, Henk R; Kazemier, Geert; van Eijck, Casper H J; Haringsma, Jelle; Kuipers, Ernst J; Bruno, Marco J

    2012-04-01

    Fully-covered self expandable metal stents (fcSEMSs) are an alternative to progressive plastic stenting for the treatment of benign biliary strictures (BBS) with the prospect of a higher treatment efficacy and the need for fewer ERCPs, thereby reducing the burden for patients and possibly costs. Key to this novel treatment is safe stent removal. To investigate the feasibility and safety of stent removal of a fcSEMS with a proximal retrieval lasso: a long wire thread integrated in the proximal ends of the wire mesh that hangs freely in the stent lumen. Pulling it enables gradual removal of the stent inside-out. A secondary aim was success of stricture resolution. Non-randomized, prospective follow-up study with 3 sequential cohorts of 8 patients with BBS. Academic tertiary referral center. Eligible patients had strictures either postsurgical (post-cholecystectomy (LCx) or liver transplantation (OLT)), due to chronic pancreatitis (CP), or papillary stenosis (PF). Strictures had to be located at least 2 cm below the liver hilum. All patients had one plastic stent in situ across the stricture and had not undergone previous treatment with either multiple plastic stents or fcSEMS. The first cohort of patients underwent stent placement for 2 months, followed by 3 months if the stricture had not resolved. The second and third cohort started with 3 months and 4 months, respectively, both followed by another 4 months if indicated. Treatment success was defined by stricture resolution at cholangiography, the ability to pass an inflated extraction balloon and clinical follow-up (at least 6 months). safety of stent removal. Secondary outcomes were complications and successful stricture resolution. A total of 23 patients (11 female; 20-67 yrs) were eligible for final analysis. One patient developed a malignant neuroendocrine tumor in the setting of CP. Strictures were caused by CP (13), OLT (6), LCx (3) and PF (1). In total 39 fcSEMS were placed and removed. Removals were easy

  7. Prospective Evaluation of Two iStent® Trabecular Stents, One iStent Supra® Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes.

    Science.gov (United States)

    Myers, Jonathan S; Masood, Imran; Hornbeak, Dana M; Belda, Jose I; Auffarth, Gerd; Jünemann, Anselm; Giamporcaro, Jane Ellen; Martinez-de-la-Casa, Jose M; Ahmed, Iqbal Ike K; Voskanyan, Lilit; Katz, L Jay

    2018-03-01

    This study evaluates long-term outcomes of two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin in eyes with refractory open angle glaucoma (OAG). Prospective ongoing 5-year study of 80 eligible subjects (70 with 4-year follow-up) with OAG and IOP ≥ 18 mmHg after prior trabeculectomy and while taking 1-3 glaucoma medications. Subjects received two iStent ® trabecular micro-bypass stents, one iStent Supra ® suprachoroidal stent, and postoperative travoprost. Postoperative IOP was measured with medication and annually following medication washouts. Performance was measured by the proportion of eyes with ≥ 20% IOP reduction on one medication (the protocol-specified prostaglandin) versus preoperative medicated IOP (primary outcome); and the proportion of eyes with postoperative IOP ≤ 15 and ≤ 18 mmHg on one medication (secondary outcome). Additional clinical and safety data included medications, visual field, pachymetry, gonioscopy, adverse events, visual acuity, and slit-lamp and fundus examinations. Preoperatively, mean medicated IOP was 22.0 ± 3.1 mmHg on 1.2 ± 0.4 medications, and mean unmedicated IOP was 26.4 ± 2.4 mmHg. Postoperatively, among eyes without later cataract surgery, mean medicated IOP at all visits through 48 months was ≤ 13.7 mmHg (≥ 37% reduction), and annual unmedicated IOP was ≤ 18.4 mmHg (reductions of ≥ 30% vs. preoperative unmedicated IOP and ≥ 16% vs. preoperative medicated IOP). At all postoperative visits among eyes without additional surgery or medication, ≥ 91% of eyes had ≥ 20% IOP reduction on one medication versus preoperative medicated IOP. At month 48, 97 and 98% of eyes achieved IOP ≤ 15 and ≤ 18 mmHg, respectively, on one medication. Six eyes required additional medication, no eyes required additional glaucoma surgery, and safety measurements were favorable throughout follow-up. IOP control was achieved safely with two

  8. Cerrobend shielding stents for buccal carcinoma patients

    Directory of Open Access Journals (Sweden)

    Karma Yangchen

    2016-01-01

    Full Text Available Buccal carcinoma is one of the most common oral malignant neoplasms, especially in the South Asian region. Radiotherapy, which plays a significant role in the treatment of this carcinoma, has severe adverse effects. Different types of prosthesis may be constructed to protect healthy tissues from the adverse effects of treatment and concentrate radiation in the region of the tumor mass. However, the technique for fabrication of shielding stent with Lipowitz's alloy (cerrobend/Wood's alloy has not been well documented. This article describes detailed technique for fabrication of such a stent for unilateral buccal carcinoma patients to spare the unaffected oral cavity from potential harmful effects associated with radiotherapy.

  9. [Treatment of tracheobronchomalacia with expandable metallic stents].

    Science.gov (United States)

    Antón-Pacheco Sánchez, J; García Vázquez, A; Cuadros García, J; Cano Novillo, I; Villafruela Sanz, M; Berchi García, F J

    2002-10-01

    Tracheomalacia is an unfrequent disease that causes tracheal collapse during breathing. It is generally associated to esophageal atresia, but cases of primary tracheomalacia and others secondary to extrinsic compression, have also been described. Spontaneous resolution is generally the rule and only a few cases need surgical treatment. When this therapy fails or is not indicated for any reason, endoluminal tracheobronchial stents may be used. We have treated two patients with four expandable metallic stents: one had severe tracheomalacia associated to esophageal atresia and the other tracheobronchomalacia secondary to cardiomegaly. Results have been good in both cases.

  10. The interventional treatment with two stents in malignant hilar obstruction

    International Nuclear Information System (INIS)

    Gao Kun; Dai Dingke; Zhao Renyou; Qian Xiaojun

    2006-01-01

    Objective: To evaluate the methodology of interventional treatment with two stents in malignant hilar obstructions. Methods: Retrospectively analyzing the two stents, interventional management of unresectable malignant hilar obstruction in 22 patients included unilateral and bilateral puncture routes for placing 'T' shape stent set and 'Y' shape stent set, respectively; together with recording the related complications. Results: The overall technical success rate was 100%, without severe complication. The total serum bilirubin reduced from (337.9 + 81.7) μmol/L before procedure to (129.1 + 51.1) μmol/L after the stent placement. Stent obstruction was found in 8 cases at 6 months; 5 cases by the time of 6-12 months and only 2 cases after 1 year. Conclusion: The method of two stents interventional treatment is a safe and useful management for malignant hilar obstructions. (authors)

  11. A Case of Late Femoral Pseudoaneurysm Caused by Stent Disconnection

    International Nuclear Information System (INIS)

    Rivolta, Nicola; Fontana, Federico; Piffaretti, Gabriele; Tozzi, Matteo; Carrafiello, Gianpaolo

    2010-01-01

    We present the case of a late superficial femoral artery stent disconnection causing an asymptomatic pseudoaneurysm successfully treated with a stent-graft. A 67-year-old female was referred to our department for evaluation of claudication of the left lower limb and was diagnosed to have a total occlusion of the superficial femoral artery. Three nitinol stents were used to revascularize this artery. At 48 months, duplex-ultrasonography control revealed the presence of a 45-mm saccular femoral dilatation; X-rays and CT angiography showed fractures of the proximal stents and the presence of a pseudoaneurysm at the site of the distal stents disconnection. The pseudoaneurysm was excluded using two stent-grafts. We conclude that patients and surgeons should be aware of structural complications with all stents. Rigorous follow-up controls should be mandatory. Endovascular repair proved to be feasible and durable to manage a previous endovascular procedure.

  12. Role of stents and laser therapy in biliary strictures

    Science.gov (United States)

    Chennupati, Raja S.; Trowers, Eugene A.

    2001-05-01

    The most frequent primary cancers causing malignant obstructive jaundice were pancreatic cancer (57%), hilar biliary cancer (19% including metastatic disease), nonhilar biliary cancer (14%) and papillary cancer (10%). Endoscopic stenting has widely replaced palliative surgery for malignant biliary obstruction because of its lower risk and cost. Self-expandable metal stents are the preferred mode of palliation for hilar malignancies. Plastic stents have a major role in benign biliary strictures. Major complications and disadvantages associated with metallic stents include high cost, cholangitis. malposition, migration, unextractability, and breakage of the stents, pancreatitis and stent dysfunction. Dysfunction due to tumor ingrowth can be relieved by thermal methods (argon plasma coagulator therapy). We present a concise review of the efficacy of metallic stents for palliation of malignant strictures.

  13. Colorectal Stenting in Malignant Large Bowel Obstruction: The Learning Curve

    Directory of Open Access Journals (Sweden)

    D. Williams

    2011-01-01

    Full Text Available Aim. Self-expanding metal stents (SEMSs are increasingly used for the palliation of metastatic colorectal cancer and as a bridge to surgery for obstructing tumours. This case series analyses the learning curve and changes in practice of colorectal stenting over a three year period. Methods. A study of 40 patients who underwent placement of SEMS for the management of colorectal cancer. Patients spanned the learning curve of a single surgeon endoscopist. Results. Technical success rates increased from 82% initially, using an average of 1.7 stents per procedure, to a 94% success rate where all patients were stented using a single stent. There has been a change in practice from elective palliative stenting toward emergency preoperative stenting. Conclusion. There is a steep learning curve for the use of SEMS in the management of malignant colorectal bowel obstruction. We suggest that at least 20 cases are required for an operator to be considered experienced.

  14. Overview of evidence on emergency carotid stenting in patients with acute ischemic stroke due to tandem occlusions: a systematic review and meta-analysis.

    Science.gov (United States)

    Coelho, Andreia; Lobo, Miguel; Gouveia, Ricardo; Silveira, Diogo; Campos, Jacinta; Augusto, Rita; Coelho, Nuno; Canedo, Alexandra

    2018-01-23

    benefit. Furthermore, no prospective, randomized controlled trials demonstrating relative efficacy and safety of concomitant ICA stenting have been published to date. Additional studies must be undertaken to define the role of angioplasty and stenting of the extracranial carotid arteries in the early management of acute stroke in tandem occlusions. Until then, we recommend that ICA stenting concommintant to thrombectomy in acute stroke patients should be avoided.

  15. Results of the new nitinol self-expandable stents for distal biliary structures

    NARCIS (Netherlands)

    Smits, M.; Huibregtse, K.; Tytgat, G.

    1995-01-01

    The nitinol stent is a self-expandable spiral stent made of nickel-titanium alloy. We performed a pilot study to evaluate the method of stent insertion and stent efficacy. Twenty-eight patients with irresectable malignancy had nitinol stents inserted for obstructive jaundice due to distal biliary

  16. Endoscopic stenting in bile duct cancer increases liver volume.

    Science.gov (United States)

    Lee, Chang Hun; Kim, Seong Hun; Kim, In Hee; Kim, Sang Wook; Lee, Soo Teik; Kim, Dae Ghon; Yang, Jae Do; Yu, Hee Chul; Cho, Baik Hwan; Lee, Seung Ok

    2014-09-01

    Objective evaluation tools for assessing the effectiveness of stenting in palliative treatment of malignant biliary obstruction are not satisfactory. Effects of biliary stenting on liver volume change have never been studied. We aimed to use volumetry to analyze liver volume changes after endoscopic stenting in bile duct cancer according to the location and number of stents. Retrospective review. University hospital. Patients with a diagnosis of hilar or distal bile duct cancer and who underwent biliary metal stenting. ERCP with self-expandable metal stent placement. Liver volume change after biliary stenting and its comparison according to the location (hilar vs distal common bile duct) and number (hilar bilateral vs hilar unilateral). There were 60 patients; 31 were treated for hilar bile duct cancer (13 for bilateral stent and 18 for unilateral stent) and 29 for distal bile duct cancer. Overall mean follow-up duration was 11.7 ± 4.9 weeks. Liver volume increased 17.4 ± 24.1%. The rate of liver growth was rapid during the early period from 4 to 8 weeks. Stenting in hilar bile duct cancer tended to increase liver volume more than distal biliary stents (22.5% vs 11.9%, P = .091). In hilar bile duct cancer, unilateral and bilateral stents showed similar liver volume increases (20.1% and 25.8%, respectively; P = .512). Single center, retrospective. Biliary stenting markedly increased liver volume in both hilar and distal bile duct cancer. Our data suggest that liver volume assessment could be a useful tool for evaluating stent efficacy. Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  17. Flow Characteristics Near to Stent Strut Configurations on Femoropopliteal Artery

    Science.gov (United States)

    Paisal, Muhammad Sufyan Amir; Fadhil Syed Adnan, Syed; Taib, Ishkrizat; Ismail, Al Emran; Kamil Abdullah, Mohammad; Nordin, Normayati; Seri, Suzairin Md; Darlis, Nofrizalidris

    2017-08-01

    Femoropopiteal artery stenting is a common procedure suggested by medical expert especially for patient who is diagnosed with severe stenosis. Many researchers reported that the growth of stenosis is significantly related to the geometry of stent strut configuration. The different shapes of stent geometry are presenting the different flow pattern and re-circulation in stented femoropopliteal artery. The blood flow characteristics near to the stent geometry are predicted for the possibility of thrombosis and atherosclerosis to be formed as well as increase the growth of stenosis. Thus, this study aims to determine the flow characteristic near to stent strut configuration based on different hemodynamic parameters. Three dimensional models of stent and simplified femoropopliteal artery are modelled using computer aided design (CAD) software. Three different models of stent shapes; hexagon, circle and rectangle are simulated using computational fluid dynamic (CFD) method. Then, parametric study is implemented to predict the performance of stent due to hemodynamic differences. The hemodynamic parameters considered are pressure, velocity, low wall shear stress (WSSlow) and wall shear stress (WSS). From the observation, flow re-circulation has been formed for all simulated stent models which the proximal region shown the severe vortices. However, rectangular shape of stent strut (Type P3) shows the lowest WSSlow and the highest WSS between the range of 4 dyne/cm2 and 70 dyne/cm2. Stent Type P3 also shows the best hemodynamic stent performance as compare to others. In conclusion, Type P3 has a favourable result in hemodynamic stent performance that predicted less probability of thrombosis and atherosclerosis to be formed as well as reduces the growth of restenosis.

  18. Multidisciplinary approach to carotid stenting.

    Science.gov (United States)

    Mak, C S; Chambers, B R; Clark, D J; Molan, M; Brooks, M; Roberts, N; Fell, G; Roberts, A K; New, G; Donnan, G A

    2011-11-01

    Stroke neurologists, vascular surgeons, interventional neuroradiologists and interventional cardiologists have embraced carotid angioplasty and stenting (CAS) because of potential advantages over carotid endarterectomy (CEA). At Austin Health, a multidisciplinary neuro-interventional group was formed to standardise indications and facilitate training. The aims of this study were to describe our organisational model and to determine whether 30-day complications and early outcomes were similar to those of major trials. A clinical protocol was developed to ensure optimal management. CAS was performed on patients with high medical risk for CEA, with technically difficult anatomy for CEA, or who were randomised to CAS in a trial. From October 2003 to May 2008, 47 patients (34 male, mean age 71.5) underwent CAS of 50 carotid arteries. Forty-three cases had ipsilateral carotid territory symptoms within the previous 12 months. The main indications for CAS were high risk for CEA (n= 17) and randomised to CAS (n= 21). Interventionists were proctored in 27 cases. The procedural success rate was 94% with two cases abandoned because of anatomical problems and one because of on-table angina. Hypotension requiring vasopressor therapy occurred in 12 cases (24%). The duration of follow up was one to 44 months (mean 6.8 months). The 30-day rate of peri-procedural stroke or death was 6% and the one-year rate of peri-procedural stroke or death or subsequent ipsilateral stroke was 10.6%. Restenosis occurred in 13% (all asymptomatic). A multidisciplinary approach is a useful strategy for initiating and sustaining a CAS programme. © 2011 The Authors. Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

  19. The Role Of Inflammation In Stent Restenosis More Than 1 Year Afetr Drug Eluting Stent Implantation

    Directory of Open Access Journals (Sweden)

    Hasan Shemirani

    2011-09-01

    Full Text Available Background: In stent restenosis (ISR following endovascular interventions is the main limitation of their long-term success. Despite advances have been made during recent years to decrease restenosis, it remains a challenging clinical problem.The aim of this study was to evaluate the relationship between angiographic coronary in stent restenosis, inflammation after successful stent implantation. Methods: This study included 78 patients, 35year old and higher who underwent coronary angiography more than 1 year after drug-eluting stent (DES implantation because of symptoms suggestive ischemia. Patients were divided into ISR group (case and patent stent group (control according to angiography results. For all patients blood lipids and high sensitivity C-Reactive Protein (hsCRP were measured simultaneously. Results: Age, sex, hypertension, current smoking, and lipid profile other than High Density Lipoprotein (HDL-C of patients in the case and control groups were similar .However, HDL-C < 40mg/L was more prevalent with ISR (66.7% vs. 30.8%, p=0.002. The hsCRP level was 2.98±2.06 mg/L in the case group and 2.50±1.80 mg/L in the control group. There were no significant differences in mean hsCRP concentration between the two groups (p=0.14, however mean hsCRP level was significantly higher in men of case group than control group (3.35mg/L vs. 2.21mg/L, p<0.05. Conclusion: This study demonstrates that in men but not in women inflammation may be a predictor of in stent restenosis more than 1 year after drug eluting stent implantation. Also, high-density lipoprotein (HDL probably has protective effect against stent restenosis.

  20. Mechanical Properties of Metallic Stents: How Do These Properties Influence the Choice of Stent for Specific Lesions?

    International Nuclear Information System (INIS)

    Dyet, John F.; Watts, William G.; Ettles, Duncan F.; Nicholson, Anthony A.

    2000-01-01

    Purpose: To assess selected balloon-expandable and self-expanding stents for radial force, flexibility, radio-opacity, and trackability, and to relate these physical characteristics to potential indications for placement.Methods: Force-strain curves were plotted for each stent and the force required to produce 50% luminal narrowing was recorded. The ability of the stent to show elastic recoil following deformation was also noted. Flexibility was measured by bending the stents against a force transducer and recording the force required per degree of flexion. Radio-opacity was measured by comparing each stent against a standard aluminum step wedge. Trackability was measured by testing the ability of the stent on its delivery system to track over angles of 90 deg. and 60 deg. Results: The balloon-expandable stents showed greater radial strength and radio-opacity but, apart from the AVE Iliac Bridge stent, showed poorer flexibility and trackability. The self-expanding stents showed less radial force but were able to re-expand following deformity. They were generally more flexible and had better trackability but lower radio-opacity.Conclusion: There is no stent which exhibits all the ideal properties required and therefore the interventionist will need to keep a range of stents available if all lesions are to be addressed

  1. Covered stent placement for the treatment of malignant superior vena cava syndrome: Is unilateral covered stenting and effective?

    International Nuclear Information System (INIS)

    Cho, Young Hoon; Gwon, Dong Il; Ko, Gi Young; Ko, Heung Kyu; Kim, Jin Hyoung; Shin, Ji Hoon; Yoon, Hyun Ki; Sung, Kyu Bo

    2014-01-01

    To evaluate the safety and efficacy of unilateral covered stent placement in patients with malignant superior vena cava (SVC) syndrome. Between October 2008 and November 2012, expanded polytetrafluoroethylene-covered stent placement for malignant SVC syndrome was performed in 40 consecutive patients (35 men and five women; mean age, 61.4 years; range, 35-81 years). All covered stents were unilaterally placed within the SVC or across the venous confluence when needed to relieve venous obstruction and prevent tumor overgrowth, regardless of patency of contralateral brachiocephalic veins. Stent placement was technically successful in all patients. There were no major complications. Of the 37 patients symptomatic prior to stent placement, 34 (92%) experienced complete symptomatic relief 1-8 days after stent placement. Of the 29 patients who underwent covered stent placement across the venous confluence, nine patients had patent contralateral brachiocephalic veins prior to stent placement. However, no sign of SVC obstruction or contralateral upper extremity venous thrombosis was observed during the follow-up period. Kaplan-Meier analysis revealed median patient survival of 163 days. Stent occlusion occurred in four (10%) of 40 patents. Cumulative stent patency rates at 1, 3, 6, and 12 months were 95%, 92%, 86%, and 86%, respectively. Unilateral covered stent placement appears to be a safe and effective method for treating malignant SVC syndrome, despite the location of SVC occlusion.

  2. Covered stent placement for the treatment of malignant superior vena cava syndrome: Is unilateral covered stenting and effective?

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Young Hoon; Gwon, Dong Il; Ko, Gi Young; Ko, Heung Kyu; Kim, Jin Hyoung; Shin, Ji Hoon; Yoon, Hyun Ki; Sung, Kyu Bo [Dept. of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul (Korea, Republic of)

    2014-02-15

    To evaluate the safety and efficacy of unilateral covered stent placement in patients with malignant superior vena cava (SVC) syndrome. Between October 2008 and November 2012, expanded polytetrafluoroethylene-covered stent placement for malignant SVC syndrome was performed in 40 consecutive patients (35 men and five women; mean age, 61.4 years; range, 35-81 years). All covered stents were unilaterally placed within the SVC or across the venous confluence when needed to relieve venous obstruction and prevent tumor overgrowth, regardless of patency of contralateral brachiocephalic veins. Stent placement was technically successful in all patients. There were no major complications. Of the 37 patients symptomatic prior to stent placement, 34 (92%) experienced complete symptomatic relief 1-8 days after stent placement. Of the 29 patients who underwent covered stent placement across the venous confluence, nine patients had patent contralateral brachiocephalic veins prior to stent placement. However, no sign of SVC obstruction or contralateral upper extremity venous thrombosis was observed during the follow-up period. Kaplan-Meier analysis revealed median patient survival of 163 days. Stent occlusion occurred in four (10%) of 40 patents. Cumulative stent patency rates at 1, 3, 6, and 12 months were 95%, 92%, 86%, and 86%, respectively. Unilateral covered stent placement appears to be a safe and effective method for treating malignant SVC syndrome, despite the location of SVC occlusion.

  3. Metallic stents provide better QOL than plastic stents in patients with stricture of unresectable advanced esophageal cancer

    International Nuclear Information System (INIS)

    Ohta, Kazuki; Nagahara, Akihito; Iijima, Katsuyori

    2006-01-01

    The aim of this study was to elucidate the utility and safety of treatment with esophageal stents (plastic and metallic stents) for unresectable advanced esophageal cancer. Between 1992 and 2002, 14 cases of unresectable advanced esophageal cancer were treated with esophageal stents (the plastic stent group, 7 cases; and the metallic stent group, 7 cases). Of these, 10 cases had a history of chemotherapy and or radiotherapy. An improvement in oral intake and performance status (PS), survival time, periods at home, and adverse events were compared between the two groups. After stenting, oral intake and PS were significantly improved in the metallic stent group. Follow-up at home was possible in 71.4%. There was no significant difference in survival or duration of time at home between the two groups. All adverse events were controllable and there was no difference between the two groups. Stenting not only improved oral intake and PS but also allowed a stay at home, resulting in a marked improvement in patients' quality of life (QOL). Stenting was performed safely even in cases with a history of radiotherapy. There was no difference in survival, ratios of staying at home, and safety between the two groups, but QOL was significantly improved in the metallic stent group. These outcomes indicate that placement of metallic stents should be actively considered to treat stricture due to advanced esophageal cancer. (author)

  4. A novel balloon assisted two-stents telescoping technique for repositioning an embolized stent in the pulmonary conduit.

    Science.gov (United States)

    Kobayashi, Daisuke; Gowda, Srinath T; Forbes, Thomas J

    2014-08-01

    A 9-year-old male, with history of pulmonary atresia and ventricular septal defect, status post complete repair with a 16 mm pulmonary homograft in the right ventricular outflow tract (RVOT) underwent 3110 Palmaz stent placement for conduit stenosis. Following deployment the stent embolized proximally into the right ventricle (RV). We undertook the choice of repositioning the embolized stent into the conduit with a transcatheter approach. Using a second venous access, the embolized stent was carefully maneuvered into the proximal part of conduit with an inflated Tyshak balloon catheter. A second Palmaz 4010 stent was deployed in the distal conduit telescoping through the embolized stent. The Tyshak balloon catheter was kept inflated in the RV to stabilize the embolized stent in the proximal conduit until it was successfully latched up against the conduit with the deployment of the overlapping second stent. One year later, he underwent Melody valve implantation in the pre-stented conduit relieving conduit insufficiency. This novel balloon assisted two-stents telescoping technique is a feasible transcatheter option to secure an embolized stent from the RV to the RVOT. © 2014 Wiley Periodicals, Inc.

  5. Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study.

    Science.gov (United States)

    Belle, Loic; Motreff, Pascal; Mangin, Lionel; Rangé, Grégoire; Marcaggi, Xavier; Marie, Antoine; Ferrier, Nadine; Dubreuil, Olivier; Zemour, Gilles; Souteyrand, Géraud; Caussin, Christophe; Amabile, Nicolas; Isaaz, Karl; Dauphin, Raphael; Koning, René; Robin, Christophe; Faurie, Benjamin; Bonello, Laurent; Champin, Stanislas; Delhaye, Cédric; Cuilleret, François; Mewton, Nathan; Genty, Céline; Viallon, Magalie; Bosson, Jean Luc; Croisille, Pierre

    2016-03-01

    Delayed stent implantation after restoration of normal epicardial flow by a minimalist immediate mechanical intervention aims to decrease the rate of distal embolization and impaired myocardial reperfusion after percutaneous coronary intervention. We sought to confirm whether a delayed stenting (DS) approach (24-48 hours) improves myocardial reperfusion, versus immediate stenting, in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. In the prospective, randomized, open-label minimalist immediate mechanical intervention (MIMI) trial, patients (n=140) with ST-segment-elevation myocardial infarction ≤12 hours were randomized to immediate stenting (n=73) or DS (n=67) after Thrombolysis In Myocardial Infarction 3 flow restoration by thrombus aspiration. Patients in the DS group underwent a second coronary arteriography for stent implantation a median of 36 hours (interquartile range 29-46) after randomization. The primary end point was microvascular obstruction (% left ventricular mass) on cardiac magnetic resonance imaging performed 5 days (interquartile range 4-6) after the first procedure. There was a nonsignificant trend toward lower microvascular obstruction in the immediate stenting group compared with DS group (1.88% versus 3.96%; P=0.051), which became significant after adjustment for the area at risk (P=0.049). Median infarct weight, left ventricular ejection fraction, and infarct size did not differ between groups. No difference in 6-month outcomes was apparent for the rate of major cardiovascular and cerebral events. The present findings do not support a strategy of DS versus immediate stenting in patients with ST-segment-elevation infarction undergoing primary percutaneous coronary intervention and even suggested a deleterious effect of DS on microvascular obstruction size. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360242. © 2016 American Heart Association, Inc.

  6. Predictive factors for the failure of endoscopic stent-in-stent self-expandable metallic stent placement to treat malignant hilar biliary obstruction.

    Science.gov (United States)

    Sugimoto, Mitsuru; Takagi, Tadayuki; Suzuki, Rei; Konno, Naoki; Asama, Hiroyuki; Watanabe, Ko; Nakamura, Jun; Kikuchi, Hitomi; Waragai, Yuichi; Takasumi, Mika; Sato, Yuki; Hikichi, Takuto; Ohira, Hiromasa

    2017-09-14

    To investigate the factors predictive of failure when placing a second biliary self-expandable metallic stents (SEMSs). This study evaluated 65 patients with an unresectable malignant hilar biliary obstruction who were examined in our hospital. Sixty-two of these patients were recruited to the study and divided into two groups: the success group, which consisted of patients in whom a stent-in-stent SEMS had been placed successfully, and the failure group, which consisted of patients in whom the stent-in-stent SEMS had not been placed successfully. We compared the characteristics of the patients, the stricture state of their biliary ducts, and the implemented endoscopic retrograde cholangiopancreatography (ERCP) procedures between the two groups. The angle between the target biliary duct stricture and the first implanted SEMS was significantly larger in the failure group than in the success group. There were significantly fewer wire or dilation devices (ERCP catheter, dilator, or balloon catheter) passing the first SEMS cell in the failure group than in the success group. The cut-off value of the angle predicting stent-in-stent SEMS placement failure was 49.7 degrees according to the ROC curve (sensitivity 91.7%, specificity 61.2%). Furthermore, the angle was significantly smaller in patients with wire or dilation devices passing the first SEMS cell than in patients without wire or dilation devices passing the first SEMS cell. A large angle was identified as a predictive factor for failure of stent-in-stent SEMS placement.

  7. Scintigraphic examinations after stent implantation in central airways; Szintigraphische Untersuchungen bei Stents in den zentralen Atemwegen

    Energy Technology Data Exchange (ETDEWEB)

    Richter, W.S.; Kettner, B.I.; Munz, D.L. [Klinik und Poliklinik fuer Nuklearmedizin, Universitaetsklinikum Charite, Medizinische Fakulteat der Humboldt-Univ. zu Berlin (Germany)

    1998-03-01

    Endotracheal and endobronchial stent implantation has been developed as an effective treatment of benign and malignant airway stenosis and of tracheo- or bronchoesophageal fistulas. The selection of the stent type depends on the kind and site of disease. Chest X-ray and bronchoscopy are the procedures of choice for monitoring of stent position, structure, and function. However, with scintigraphic methods the effects of stent implantation on pulmonary ventilation and perfusion can be assessed non-invasively. The validation of the effect of a stent implantation on mucociliary and tussive clearance remains to be elucidated. (orig.) [Deutsch] Die endotracheale und -bronchiale Stentimplantation wurde in den letzten Jahren als effektive Massnahme bei benignen und malignen Stenosen der Atemwege, drohendem Atemwegsverschluss und bei tracheo- bzw. bronchooesophagealen Fisteln eingefuehrt. Der gewaehlte Stenttyp richtet sich nach dem Implantationsort und den krankheitsbedingten Veraenderungen. Zum Monitoring von Lage, Struktur und Funktion eines Stents dienen Thoraxroentgenaufnahmen und die Bronchoskopie. Nuklearmedizinische Verfahren koennen nicht-invasiv den Effekt der Stenteinlage auf Lungenventilation und -perfusion belegen. Die Validierung des Effekts einer Stentimplantation auf die mukoziliaere und tussive Clearance steht noch aus. (orig.)

  8. Creation of individual ideally shaped stents using multi-slice CT: in vitro results from the semi-automatic virtual stent (SAVS) designer

    International Nuclear Information System (INIS)

    Hyodoh, Hideki; Katagiri, Yoshimi; Hyodoh, Kazusa; Akiba, Hidenari; Hareyama, Masato; Sakai, Toyohiko

    2005-01-01

    To plan stent-grafting for thoracic aortic aneurysm with complicated morphology, we created a virtual stent-grafting program [Semi Automatic Virtual Stent (SAVS) designer] using three-dimensional CT data. The usefulness of the SAVS designer was evaluated by measurement of transformed anatomical and straight stents. Curved model images (source, multi-planer reconstruction and volume rendering) were created, and a hollow virtual stent was produced by the SAVS designer. A straight Nitinol stent was transformed to match the curved configuration of the virtual stent. The accuracy of the anatomical stent was evaluated by experimental strain phantom studies in comparison with the straight stent. Mean separation length was 0 mm in the anatomical stent [22 mm outer diameter (OD)] and 5 mm in the straight stent (22 mm OD). The straight stent strain voltage was four times that of the anatomical stent at the stent end. The anatomical stent is useful because it fits the curved structure of the aorta and reduces the strain force compared to the straight stent. The SAVS designer can help to design and produce the anatomical stent. (orig.)

  9. Stent implantation into the tracheo-bronchial system in rabbits: histopathologic sequelae in bare metal vs. drug-eluting stents.

    Science.gov (United States)

    Sigler, Matthias; Klötzer, Julia; Quentin, Thomas; Paul, Thomas; Möller, Oliver

    2015-12-01

    Stent implantation into the tracheo-bronchial system may be life-saving in selected pediatric patients with otherwise intractable stenosis of the upper airways. Following implantation, significant tissue proliferation may occur, requiring re-interventions. We sought to evaluate the effect of immunosuppressive coating of the stents on the extent of tissue proliferation in an animal model. Bare metal and sirolimus-coated stents (Bx Sonic and Cypher Select, Johnson & Johnson, Cordis) were implanted into non-stenotic lower airways of New Zealand white rabbits (weight 3.1 to 4.8 kg). Three stents with sirolimus coating and six bare metal stents could be analyzed by means of histology and immunohistochemistry 12 months after implantation. On a macroscopic evaluation, all stents were partially covered with a considerable amount of whitish tissue. Histologically, these proliferations contained fiber-rich connective tissue and some fibromuscular cells without significant differences between both stent types. The superficial tissue layer was formed by typical respiratory epithelium and polygonal cells. Abundant lymphocyte infiltrations and moderate granulocyte infiltrations were found in both groups correspondingly, whereas foreign-body reaction was more pronounced around sirolimus-eluting stents. After stent implantation in the tracheo-bronchial system of rabbits, we found tissue reactions comparable to those seen after stent implantation into the vascular system. There was no difference between coated and uncoated stents with regard to quality and quantity of tissue proliferation. We found, however, a significantly different inflammatory reaction with a more pronounced foreign-body reaction in sirolimus-coated stents. In our small series, drug-eluting stents did not exhibit any benefit over bare metal stents in an experimental setting.

  10. Hyperperfusion syndrome after carotid stent angioplasty

    Energy Technology Data Exchange (ETDEWEB)

    Grunwald, I.Q.; Politi, M.; Reith, W.; Krick, C.; Karp, K.; Zimmer, A.; Struffert, T.; Kuehn, A.L.; Papanagiotou, P. [University of the Saarland, Department for Interventional and Diagnostic Neuroradiology, Homburg (Germany); Roth, C.; Haass, A. [University of the Saarland, Clinic for Neurology, Homburg (Germany)

    2009-03-15

    This study assesses the incidence and causes of hyperperfusion syndrome occurring after carotid artery stenting (CAS). We retrospectively reviewed the clinical database of 417 consecutive patients who were treated with CAS in our department to identify patients who developed hyperperfusion syndrome and/or intracranial hemorrhage. Magnetic resonance imaging (MRI) including fluid-attenuated inversion recovery and diffusion-weighted imaging was performed before and after CAS in 269 cases. A Spearman's rho nonparametric correlation was performed to determine whether there was a correlation between the occurrence/development of hyperperfusion syndrome and the patient's age, degree of stenosis on the stented and contralateral side, risk factors such as diabetes, smoking, hypertension, adiposity, gender and fluoroscopy time, and mean area of postprocedural lesions as well as preexisting lesions. Significance was established at p < 0.05. Of the 417 carotid arteries stented and where MRI was also completed, we found hyperperfusion syndrome in 2.4% (ten cases). Patients who had preexisting brain lesions (previous or acute stroke) were at a higher risk of developing hyperperfusion syndrome (p = 0.022; Spearman's rho test). We could not validate any correlation with the other patient characteristics. Extensive microvascular disease may be a predictor of hyperperfusion syndrome after carotid stent placement. We believe that further studies are warranted to predict more accurately which patients are at greater risk of developing this often fatal complication. (orig.)

  11. Covered stent to exclude intravascular thrombus.

    Science.gov (United States)

    Liistro, Francesco; Stankovic, Goran; Di Mario, Carlo; Montorfano, Matteo; Briguori, Carlo; Colombo, Antonio

    2002-04-01

    To describe the utility of stent-graft implantation to avoid distal embolization from a large thrombus-containing lesion. A 67-year-old man was evaluated for recent onset of disabling left leg claudication. Angiography disclosed a mobile lobular mass occluding the left common iliac artery; irregular staining suggested an atherothrombotic lesion. Through a percutaneous ipsilateral access and an 8-F sheath, a balloon-expandable Jostent peripheral stent-graft was positioned with the distal edge immediately proximal to the internal iliac artery ostium. A prominent "waist" at the center of the balloon confirmed entrapment of the thrombotic mass. Completion angiography showed an optimal result with no residual stenosis or evidence of distal embolization. At 6-month follow-up, the patient was asymptomatic with angiographically documented luminal patency and no evidence of in-stent stenosis. Stent-graft implantation appears a viable treatment alternative for thrombus-containing lesions, particularly when the thrombotic material is localized or is in a large vessel.

  12. Hemi-Intravascular Stenting for Supermicrosurgical Anastomosis

    Directory of Open Access Journals (Sweden)

    Kensuke Tashiro, MD

    2017-11-01

    Conclusions:. Hemi-IVaS could be a useful alternative to conventional intravascular stenting techniques and is also effective for supermicrosurgical perforator-to-perforator anastomosis. Further studies are needed to improve the success rate and to explore its other possible utilizations in supermicrosurgery.

  13. Functional Nanoarchitectures For Enhanced Drug Eluting Stents

    Science.gov (United States)

    Saleh, Yomna E.; Gepreel, Mohamed A.; Allam, Nageh K.

    2017-01-01

    Different strategies have been investigated to allow for optimum duration and conditions for endothelium healing through the enhancement of coronary stents. In this study, a nanoarchitectured system is proposed as a surface modification for drug eluting stents. Highly oriented nanotubes were vertically grown on the surface of a new Ni-free biocompatible Ti-based alloy, as a potential material for self-expandable stents. The fabricated nanotubes were self-grown from the potential stent substrate, which are also proposed to enhance endothelial proliferation while acting as drug reservoir to hinder Vascular Smooth Muscle Cells (VSMC) proliferation. Two morphologies were synthesized to investigate the effect of structure homogeneity on the intended application. The material was characterized by field-emission scanning electron microscope (FESEM), X-ray diffraction (XRD), Raman spectroscopy, energy dispersive X-ray spectroscopy (EDX), and X-ray photoelectron spectroscopy (XPS). Nanoindentation technique was used to study the mechanical properties of the fabricated material. Cytotoxicity and proliferation studies were performed and compared for the two fabricated nanoarchitectures, versus smooth untextured samples, using in-vitro cultured endothelial cells. Finally, the drug loading capacity was experimentally studied and further supported by computational modeling of the release profile.

  14. Oesphageal Stenting for palliation of malignant mesothelioma

    Directory of Open Access Journals (Sweden)

    Rahamim Joseph

    2008-01-01

    Full Text Available Abstract Dyspahgia in patients with malignant mesothelioma is usually due to direct infiltration of the eosophagus by the tumour. It can be distressing for the patient and challenging for the physician to treat. We describe three cases in which this condition has been successfully palliated with self expanding esophageal stents.

  15. Risk factors for proximal migration of biliary tube stents.

    Science.gov (United States)

    Kawaguchi, Yoshiaki; Ogawa, Masami; Kawashima, Yohei; Mizukami, Hajime; Maruno, Atsuko; Ito, Hiroyuki; Mine, Tetsuya

    2014-02-07

    To analyze the risk factors for biliary stent migration in patients with benign and malignant strictures. Endoscopic stent placement was performed in 396 patients with bile duct stenosis, at our institution, between June 2003 and March 2009. The indications for bile duct stent implantation included common bile duct stone in 190 patients, malignant lesions in 112, chronic pancreatitis in 62, autoimmune pancreatitis in 14, trauma in eight, surgical complications in six, and primary sclerosing cholangitis (PSC) in four. We retrospectively examined the frequency of stent migration, and analyzed the patient factors (disease, whether endoscopic sphincterotomy was performed, location of bile duct stenosis and diameter of the bile duct) and stent characteristics (duration of stent placement, stent type, diameter and length). Moreover, we investigated retrieval methods for migrated stents and their associated success rates. The frequency of tube stent migration in the total patient population was 3.5%. The cases in which tube stent migration occurred included those with common bile duct stones (3/190; 1.6%), malignant lesions (2/112; 1.8%), chronic pancreatitis (4/62; 6.5%), autoimmune pancreatitis (2/14; 14.3%), trauma (1/8; 12.5%), surgical complications (2/6; 33.3%), and PSC (0/4; 0%). The potential risk factors for migration included bile duct stenosis secondary to benign disease such as chronic pancreatitis and autoimmune pancreatitis (P = 0.030); stenosis of the lower bile duct (P = 0.031); bile duct diameter > 10 mm (P = 0.023); duration of stent placement > 1 mo (P = 0.007); use of straight-type stents (P stents (P stents was successful in all cases. The grasping technique, using a basket or snare, was effective for pig-tailed or thin and straight stents, whereas the guidewire cannulation technique was effective for thick and straight stents. Migration of tube stents within the bile duct is rare but possible, and it is important to determine the risk factors

  16. Assessment Of Coronary Arterial Stents By Multislice-CT Angiography

    International Nuclear Information System (INIS)

    Maintz, D.; Fallenberg, E. M.; Heindel, W.; Fischbach, R.; Grude, M.

    2003-01-01

    Purpose: To assess patency and lumen visibility of coronary artery stents by multislice-CT angiography (MSCTA) in comparison with conventional coronary angiography as the standard of reference. Material and Methods: 47 stents of 13 different types were evaluated in 29 patients. MSCTA was performed on a 4-slice scanner with a standard coronary protocol (detector collimation 4 x 1 mm; table feed 1.5 mm/rotation, 400 mAs, 120 kV). Image evaluation was performed by two readers who were blinded to the reports from the catheter angiography. MIP reconstructions were evaluated for image quality on a 4-point scale (1 = poor, 4 = excellent) and stent patency (contrast distal to the stent as an indirect patency sign). Axial images and multiplanar reformations through the stents were used for assessment of stent lumen visibility (measurement of the visible stent lumen diameter) and detection of relevant in-stent stenosis (50%). Results: Image quality was fair to good on average (score 2.64 ± 1.0) and depended on the heart rate (heart rate 45-60: average score 3.2, heart rate 61-70: average score 2.8, heart rate >71: average score 1.4). Thirty-seven stents were correctly classified as patent, 1 was correctly classified as occluded and 9 stents were not assessable due to insufficient image quality because of triggering artifacts. Parts of the stent lumen could be visualized in 30 cases. On average, 20-40% of the stent lumen diameter was visible. Twenty-five stents were correctly classified as having no stenosis, 1 was falsely classified as stenosed, 1 was correctly classified as occluded. In 20 stents lumen visibility was not sufficient for stenosis evaluation. Conclusion: Although the stent lumen may be partly visualized in most stents, a reliable evaluation of in-stent stenoses does not seem practical by 4-slice MSCT. Nevertheless, for stent patency evaluation, MS-CTA might provide valuable clinical information. With submillimeter MSCT (e.g. 16-slice scanners) and more

  17. Current status of infrapopliteal artery stenting in patients with critical limb ischemia Estado atual do uso de stents na artéria infrapolítea em pacientes com isquemia crítica do membro

    Directory of Open Access Journals (Sweden)

    Marc Bosiers

    2008-09-01

    Full Text Available Due to the fear that early thrombosis and late luminal loss resulting from intimal hyperplasia might impede sustained patency of small-caliber arteries, such as those of the infrapopliteal bed, stent implantation in below-knee vessels remains controversial and is generally reserved for cases with a suboptimal outcome after percutaneous transluminal angioplasty (i.e. > 50% residual stenosis, flow-limiting dissection. Although evidence starts to build, favoring the use of stenting in the tibial area, results of well-conducted randomized controlled trials have to be awaited to change this strategy. Because of diameter similarities with coronary arteries, the first stents applied in the infrapopliteal vessels were all coronary devices. Once the feasibility of the stenting approach with these coronary products was shown, device manufacturers started to develop a dedicated infrapopliteal product range. To date, a broad spectrum of stent types has been used and investigated for the given indication. This article overviews the available literature and results of different balloon-expandable (bare metal, passive coated, drug eluting, self-expanding and absorbable stent types available for below-the-knee application and gives recommendations for future device technology advancements.Devido ao receio de que a trombose precoce ou a estenose tardia por hiperplasia intimal possam impedir a manutenção da perviedade em vasos de pequeno calibre, o uso de stents pós-angioplastia no leito arterial infrapoplíteo permanece controverso e geralmente é reservado aos casos de resultado subótimo após angioplastia transluminal percutânea (isto é, estenose residual > 50% ou dissecção com limitação do fluxo. Apesar de evidências começarem a favorecer o uso de stents no segmento tibial, é necessário aguardar o resultado de ensaios controlados, randomizados e bem conduzidos para mudar esta estratégia. Sendo estes vasos infrapoplíteos de diâmetro similar

  18. Comparison of Self-Expanding Polyethylene Terephthalate and Metallic Stents Implanted in Porcine Iliac Arteries

    International Nuclear Information System (INIS)

    Wilczek, Krzysztof; Scheerder, Ivan de; Wang Kai; Verbeken, Eric; Piessens, Jan

    1996-01-01

    Purpose: Comparison of the biocompatibility of self-expanding polyethylene terephthalate (PET) stents with self-expanding metallic stents (Wallstents). Methods: Diameter- and length-matched PET stents and Wallstents were symmetrically implanted in the paired iliac arteries of 13 crossbred domestic swine. Stent deployment was studied angiographically and with intravascular ultrasound immediately after stent implantation. The angiographic stented lumen diameter was measured using quantitative vessel analysis before, immediately after stenting, and at 6-week follow-up. Cross-section histopathology and area morphometry were performed. Results: Immediately poststenting, intravascular ultrasound revealed proximal dislocation of 5 of the 13 PET stents, whereas all metal stents were firmly embedded at the implantation site. At 6-week follow-up, three of the remaining PET stents were totally or subtotally occluded by organized thrombus, whereas all metal stents were patent. Compared with immediately poststenting, the angiographic lumen diameter within the five remaining PET stents was reduced by 30%, and that of the metallic stents was virtually unaltered (p < 0.02). This observation was confirmed by postmortem morphometry, wherein the PET-stented vessel segments a diameter stenosis of 40% was measured vs only 9% in the metallic stents (p < 0.0001). Conclusion: PET-stent deployment is difficult to control due to the lack of radiopacity of this stent. PET stents seem to be more thrombogenic and lead to significantly more neointimal proliferation than metallic stents

  19. Renal Artery Stenosis in Patients with Resistant Hypertension: Stent It or Not?

    Science.gov (United States)

    Van der Niepen, Patricia; Rossignol, Patrick; Lengelé, Jean-Philippe; Berra, Elena; Sarafidis, Pantelis; Persu, Alexandre

    2017-01-01

    After three large neutral trials in which renal artery revascularization failed to reduce cardiovascular and renal morbidity and mortality, renal artery stenting became a therapeutic taboo. However, this is probably unjustified as these trials have important limitations and excluded patients most likely to benefit from revascularization. In particular, patients with severe hypertension were often excluded and resistant hypertension was either poorly described or not conform to the current definition. Effective pharmacological combination treatment can control blood pressure in most patients with renovascular hypertension. However, it may also induce further renal hypoperfusion and thus accelerate progressive loss of renal tissue. Furthermore, case reports of patients with resistant hypertension showing substantial blood pressure improvement after successful revascularization are published over again. To identify those patients who would definitely respond to renal artery stenting, properly designed randomized clinical trials are definitely needed.

  20. Stents: Biomechanics, Biomaterials, and Insights from Computational Modeling.

    Science.gov (United States)

    Karanasiou, Georgia S; Papafaklis, Michail I; Conway, Claire; Michalis, Lampros K; Tzafriri, Rami; Edelman, Elazer R; Fotiadis, Dimitrios I

    2017-04-01

    Coronary stents have revolutionized the treatment of coronary artery disease. Improvement in clinical outcomes requires detailed evaluation of the performance of stent biomechanics and the effectiveness as well as safety of biomaterials aiming at optimization of endovascular devices. Stents need to harmonize the hemodynamic environment and promote beneficial vessel healing processes with decreased thrombogenicity. Stent design variables and expansion properties are critical for vessel scaffolding. Drug-elution from stents, can help inhibit in-stent restenosis, but adds further complexity as drug release kinetics and coating formulations can dominate tissue responses. Biodegradable and bioabsorbable stents go one step further providing complete absorption over time governed by corrosion and erosion mechanisms. The advances in computing power and computational methods have enabled the application of numerical simulations and the in silico evaluation of the performance of stent devices made up of complex alloys and bioerodible materials in a range of dimensions and designs and with the capacity to retain and elute bioactive agents. This review presents the current knowledge on stent biomechanics, stent fatigue as well as drug release and mechanisms governing biodegradability focusing on the insights from computational modeling approaches.