NCT00299429已完成不适用
Randomised Comparison of Minimally Invasive Direct Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention With Drug-eluting Stents in Patients With Proximal Stenosis of the Left Anterior Descending Coronary Artery
University of Leipzig2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2003年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally invasive bypass surgery in patients with isolated proximal left anterior descending coronary arteries in terms of non-inferiority of an end point combining mortality, acute myocardial infarction and rate of reintervention of the target vessel within one year.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single-vessel disease of the proximal LAD with a stenosis > 50% (multivessel disease only if further coronary vessel stenoses do not require treatment)
- •Patients with angina pectoris (CCS 1-4)
- •Asymptomatic patients if clear signs of ischemia in the segments supplied by the LAD as assessed by bicycle ergometry or treadmill and/or scintigraphically and/or stress echo
- •Patients for whom both methods of treatment are equally possible
- •Consensus between the cardiac surgeon and the cardiologist that both inclusion and
排除标准
- •are met in the selected case
- •Informed consent of the patient.
- •Exclusion Criteria:
- •Patients < 18 years
- •Previous coronary artery bypass surgery
- •Concomitant diseases that lead to a greater risk for each of the treatment strategies
- •Significant peripheral arterial occlusive disease
- •Concomitant disease with limited life expectancy (e.g. malignant tumours that have not been curatively treated)
- •Objective follow-up examination not possible due to physical or mental handicap
- •Participation in another study.
- •Angiographical exclusion criteria:
- •Left main stem stenosis
- •Multivessel disease for which surgical or interventional therapy on other vessel areas is required.
- •Diagonal/septal branch > 1.5 mm, which might be compromised by a stent
- •Need for acute intervention (e.g. acute myocardial infarction)
- •Total occlusion of the LAD
结局指标
主要结局
Major adverse cardiac events
时间窗: 12 months
次要结局
- Perioperative complications(30 days)
- cost-effectiveness(12 months)
- CCS-Classification(12 months)
研究者
研究点 (2)
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