NCT01132495已完成不适用
Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,170
- 试验地点
- 57
- 主要终点
- Major Adverse Cardiac Event Rate (MACE)
研究概览
简要总结
The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.
详细描述
Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with
- •stable angina or,
- •stabilized angina pectoris or,
- •atypical chest pain or no chest pain but with documented silent ischemia
- •at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
- •Eligible for PCI
- •Signed written informed consent
排除标准
- •Patients in whom the preferred treatment is CABG
- •Patients with left main coronary artery disease requiring revascularization
- •Patients with a recent STEMI or Non-STEMI
- •Contra-indication to dual antiplatelet therapy
- •LVEF < 30%
- •Severe LV hypertrophy
- •Planned need for concomitant cardiac surgery
- •Extremely tortuous or calcified coronary arteries precluding FFR measurements
- •A life expectancy of less than 2 years
- •Age under 21
研究组 & 干预措施
Cohort A: PCI plus OMT
Other
PCI plus optimal medical treatment
干预措施: Stenting plus OMT (Other)
Cohort A: OMT alone
Other
Optimal medical treatment alone
干预措施: OMT (Other)
Cohort B
Other
FFR > 0.80; treatment according to local practice
干预措施: Standard of care (Other)
结局指标
主要结局
Major Adverse Cardiac Event Rate (MACE)
时间窗: 24 Month
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.
次要结局
- Overall MACE(3 years)
研究者
研究点 (57)
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