NCT00225654已完成不适用
The ELUTES Clinical Trial (European Evaluation of Paclitaxel Eluting Stent)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Angiographic in-stent % diameter stenosis and late loss at follow up.
研究概览
简要总结
ELUTES is a European multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Paclitaxel Eluting V-Flex Plus coronary stent to reduce restenosis in the coronary artery.
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
- Double
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
- •Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
- •Patient must be an acceptable candidate for coronary artery bypass surgery.
- •Patient or legal guardian must have signed informed consent.
- •Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.
排除标准
- •Patient must be less than 18 years old.
- •Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
- •Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
- •Women of child bearing potential.
- •Patient has other medical condition that may cause non-compliance with the protocol, confound the results, or is associated with limited life expectancy.
- •Patient has been diagnosed with a myocardial infarction within 72 hours prior to procedure.
结局指标
主要结局
Angiographic in-stent % diameter stenosis and late loss at follow up.
次要结局
- Major adverse events
- Total lesion revascularization
研究者
研究点 (1)
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