NCT00882219已完成3 期
XERES Trial: Clinical Evaluation of Patients With Everolimus-eluting Stent " Xience V® " Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V®
研究概览
简要总结
Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older
- •Patients affiliated to a social security or equivalent regimen
- •Patients agreeing to participate in the study (Patient with signed informed consent )
- •Patients with evidence of myocardial ischemia (stable or unstable angina, silent ischemia, positive functional exploration or a reversible modification in the ECG consistent with ischemia).
- •Patient acceptable candidate for CABG surgery
- •Patient agreeing to undergo all protocol scheduled follow-up examinations.
- •Patients who tolerate the association Aspirin (dosed 75 to 160 mg/day) and Clopidogrel at 75 mg/day for at least 6 months
- •Angiographic inclusion criteria:
- •Patient with de novo and sole in-stent restenosis (focal, diffuse or proliferative) in a non-coated metallic stent with or without any other coronary lesions.
- •Patient with target reference vessel diameter between 2.5 and 4 mm by visual estimate
- •Patient with a target lesion ≤ 22mm by visual estimate
- •Patient with a target lesion in an artery with a visual estimate of the restenosis between 50 and 99% and a TIMI flow grade > 1
- •Patient with multiple lesions, the other lesions have been treated with success
排除标准
- •Patient in emergency
- •Patient pregnant
- •Patient nursing
- •Patient unable to give informed consent personally.
- •Patient with myocardial infarction within the previous 72 hours.
- •Patient with limited life expectancy (lesser than 1 year post-inclusion)
- •Patient with unstable arrhythmia
- •Patient with left ventricular ejection fraction (LVEF) lesser than 30%
- •Patient receiver of a cardiac or any other organ transplantation or candidate to an organ transplant
- •Patient who receive or scheduled to receive chemo- or radio- therapy within the 30 days prior to any protocol-related procedure.
- •Patient treated with immunosuppressives or for known immunodepressive or auto-immune pathologies
- •Patient receiving chronically anticoagulant therapy with an INR greater than 2.5
- •Patient with known hypersensitivity or contraindications to anti-platelet drugs, everolimus, heparin, chromium cobalt alloys, nickel, tungsten, acrylic- or fluoro- polymers or sensitivity to angiographic contrast agents.
- •Patient with planned elective surgery requiring the interruption or discontinuation of anti-platelet therapy.
- •Patient with platelet count <100 000/ mm3 or >700 000mm3 ; WBC counts <3 000/mm3 or known or suspected liver disease
- •Patient with severe renal insufficiency (creatinine clearance rate < 30 ml/min), or under dialysis
- •Patient with an history of coagulopathy refusing blood transfusion
- •Patient who had a stroke/cerebrovascular accident or transient cerebrovascular ischemia in the preceding 6 months
- •Patient with urinary or gastro-intestinal bleed in the preceding 6 months
- •Patient with other known serious medical illness or known history of substance abuse (alcohol, drugs) that might result in non-compliance to the investigational plan, or interfere with the results or diminish the life expectancy to less than a year.
- •Patient enrolled in an interventional study with another medical device or drug Angiographic exclusion criteria
- •Patient with in-stent restenosis located on the left main on the coronary by-pass
- •Patient with a lesion of the in-stent restenosis located in a bifurcation including a lateral branch of diameter > 1.5mm
- •Patient with the target vessel totally occluded
- •Patient with a lesion of the restenosis previously treated with another device (with the exception of balloon-tipped catheter) such as a cutting balloon, an atherectomy, laser, brachytherapy or any another medicated stent.
- •Patient with thrombus in the target vessel
- •Patient with aorto-ostiale lesions
- •Patient with previous failures of multiple lesions treated by angioplasty.
结局指标
主要结局
Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V®
时间窗: 9 months
次要结局
- Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent(9 months)
- Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent(9 months)
- Evaluation by QCA of the in-stent binary restenosis rate(9 months)
- Evaluation of the in-segment binary restenosis rate(9 months)
- Evaluation by QCA of in-segment late loss(9 months)
- Evaluation by IVUS of the in-segment % volume obstruction after the implantation of the XIENCE V® stent(9 months)
- Evaluation by IVUS of the rate of late incomplete apposition(9 months)
- Document the number of confirmed stent thrombosis(1, 8, 9, 12 and 24 months)
- -Document the number of confirmed revascularizations (TLR, TVR)(1, 8, 9, 12 and 24 months)
- Document the rate of MACE(1, 8, 9, 12 and 24 months)
研究者
研究点 (2)
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