PCI With DES Versus CABG for Patients With Significant Left Main Stenosis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Major adverse coronary events (cardiac death, myocardial infarction, need for repeat revascularisation)
研究概览
简要总结
Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES).
The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis.
详细描述
Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES).
The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis.
The study was planned as a "non-inferiority" trial based on the hypothesis that PCI may be able to reach similar long-term results as compared to CABG.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant left main coronary stenosis >= 50%
排除标准
- •Acute myocardial infarction (STEMI < 48h)
结局指标
主要结局
Major adverse coronary events (cardiac death, myocardial infarction, need for repeat revascularisation)
次要结局
- Functional status (CCS-class)