NCT01186120已完成4 期
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-V:Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents
Seung-Jung Park11 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年8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
- 500
- 试验地点
- 11
- 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 biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) 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 V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT 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 angiographic follow-up
次要结局
- Composite of cardiac death or MI(1 year)
- Death (all-cause and cardiac)(9 months)
- target-lesion revascularization(9 months)
- target-vessel revascularization(9 months)
- 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)(12 months)
- In-stent and in-segment restenosis(9 month angiographic follow-up)
- In-stent late loss(9 month angiographic follow-up)
- Angiographic pattern of restenosis(9 month angiographic follow-up)
- stent thrombosis(ARC criteria)(9 months)
- Procedural success(at 1 day)
- Myocardial infarction(9 months)
- Composite of death or MI(1 year)
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 (11)
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