NCT01078038已完成4 期
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III: Sirolimus vs. Everolimus-eluting Stent
Seung-Jung Park20 个研究点 分布在 1 个国家目标入组 451 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 451
- 试验地点
- 20
- 主要终点
- In-segment late luminal loss
研究概览
简要总结
This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus versus everolimus-eluting stent implantation for long coronary lesions.
详细描述
Following angiography, patients with significant diameter stenosis >50% and lesion length (> 25mm) requiring single or multiple long-stent placement (total stent length >28mm) by visual estimation and eligible for LONG-DES III trial inclusion and exclusion criteria will be randomized 1:1 to a) sirolimus-eluting and b) everolimus-eluting stent by the stratified randomization method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •The patient must be at least 18 years of age.
- •Significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (>=28mm)
- •Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction
- •The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.
- •An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
- •Acute ST-segment-elevation MI or cardiogenic shock
- •Terminal illness with life expectancy <1 year
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted)
- •Patients with EF<30%.
- •Serum creatinine level >=3.0mg/dL or dependence on dialysis.
- •Patients with left main stem stenosis (>50% by visual estimate).
结局指标
主要结局
In-segment late luminal loss
时间窗: 9 month follow-up
次要结局
- All Death(one year)
- Cardiac death(9 months)
- Myocardial infarction (MI)(9 months)
- Composite of death or MI(9 months)
- Composite of cardiac death or MI(9 months)
- Target vessel revascularization (ischemia-driven and clinically-driven)(9 months)
- Target lesion revascularization (ischemia-driven and clinically-driven)(9 months)
- Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)(1 year)
- Stent thrombosis (ARC criteria)(9 months)
- In-stent late loss at 9 month angiographic follow-up(at 9 month angiographic follow-up)
- In-stent and in-segment restenosis at 9 month angiographic follow-up(at 9 month angiographic follow-up)
- Angiographic pattern of restenosis at 9 month angiographic follow-up(at 9 month angiographic follow-up)
- Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study)(at 9 month angiographic follow-up)
- Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study)(at 9 month angiographic follow-up)
- Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay.(3 days in average)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea
研究点 (20)
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