NCT01810224Unknown4 期
Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial
Onze Lieve Vrouw Hospital4 个研究点 分布在 3 个国家目标入组 206 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 206
- 试验地点
- 4
- 主要终点
- Rate of occluded bypass grafts
研究概览
简要总结
This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable angina, unstable angina or NSTEMI candidate to CABG
- •Significant LAD and/or LM lesion - proved by FFR or Angiography AND
- •At least one more, angiographycally intermediate lesion
排除标准
- •Significant valvular disease with indication to surgical replacement
- •Severe left ventricular dysfunction (EF<35%)
- •Acute STEMI
- •Atrial fibrillation, if Maze procedure is planned
结局指标
主要结局
Rate of occluded bypass grafts
时间窗: 1 year
次要结局
- a) Lenght of hospital stay; b) Changes in surgical strategy: i.e. open-chest surgery vs. mini-thoracotomy; extensive surgery versus minimal invasive approaches.(participants will be followed for the duration of hospital stay, an expected average of 3-4 weeks)
研究者
Emanuele Barbato
Doctor
Onze Lieve Vrouw Hospital
研究点 (4)
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