French Multicenter Study Assessing Angioplasty With Taxus Drug Eluting Stent in Unprotected Left Main Coronary Artery Associated to Other Coronary Lesions or Not
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 52
- 主要终点
- Coronarography
研究概览
简要总结
The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.
详细描述
Coronary artery bypass graft is the reference treatment of left main coronary artery disease. With the advancements of technology and particularly drug-eluting stents, in-stent restenosis has dramatically decreased and now it is possible to extend indications of complexes lesions such as left main coronary artery stenoses. In these particular situations,some centers performed percutaneous coronary angioplasty (PCI) with drug-eluting stents with acceptable results in terms of safety and efficacy. However, these procedures are performed at isolated sites and are not evaluated in multicenter trial.The aim of this study is to assess the safety and efficacy of this PCI with Taxus-stent in a french multicenter trial and to evaluate clinical and angiographic outcome of these patients at long-term follow-up.
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
- •The patient must be > or = 18 years of age
- •Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee
- •Aspirin + Clopidogrel > or = 12 hours before percutaneous coronary intervention (PCI)
- •Documented evidence of ischemic heart disease (clinical,biological or ECG) with unprotected left main coronary artery stenosis > or = 50% associated to other coronary lesions or not responsible of stable or unstable coronary syndrome above 48 hours
- •The target reference vessel diameter must be > or = 2.5 mm
- •Unprotected left main coronary artery disease eligible by coronary stenting
排除标准
- •Restenosis lesion in left main coronary artery
- •Known allergies to the following: aspirin, clopidogrel,ticlopidine,contrast agent or drug similar to paclitaxel
- •Acute coronary syndrome < 48 hours
- •Impaired renal function (creatinine > 180 ùmol/l) at the time of treatment
- •Life expectancy less than 36 months
- •Female of childbearing potential without reliable birth control
- •Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints
结局指标
主要结局
Coronarography
时间窗: 9 months
次要结局
- Major cardio-vascular events(1, 18 and 36 months)