NCT01175863终止4 期
Fractional Flow Reserve- And Intra-vascular Ultrasound-Guided Percutaneous Coronary Intervention With Drug-Eluting Stents in Intermediate Coronary Artery Lesion (FAVOR Study)
Ajou University School of Medicine8 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,400
- 试验地点
- 8
- 主要终点
- Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
研究概览
简要总结
This study is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary artery lesion.
详细描述
This trial is a prospective, randomized, open label, two arm designed multi-center trial. When diagnostic coronary angiogram shows that the target lesion is intermediate stenosis, IVUS and/or FFR will be performed in order to decide PCI or defer by 1:1 randomization. The patients would be followed up to 2 years clinically.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical indication:
- •Patients with angina or patients with documented silent ischemia
- •Patients who are eligible for intracoronary stenting
- •Age > 18 years old, < 75 years old
- •Angiographic indication:
- •Intermediate coronary artery disease (30-70% diameter stenosis) by visual estimation
- •Reference vessel diameter ≥ 3.0mm by visual estimation
排除标准
- •Acute or old myocardial infarction
- •Previous coronary artery bypass graft
- •Left main disease (≥ 50% stenosis)
- •In-stent restenosis lesion
- •Chronic total occlusion
- •Low ejection fraction (< 40 %)
- •Graft vessel lesion
- •History of bleeding diathesis or coagulopathy
- •Limited life-expectancy (less than 1 year) due to combined serious disease
- •Contra-indication to heparin, everolimus
- •Contraindication to aspirin, clopidogrel or cilostazol
结局指标
主要结局
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
时间窗: 1 year
次要结局
- Stent thrombosis (Academic Research Consortium criteria)(1 and 2 years)
- Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)(2 years)
- The number of anti-angina medication(1 and 2 years)
- Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group(Baseline (day 0))
- Cardiac death(1 and 2 years)
- Myocardial infarction (MI)(1 and 2 years)
- Composite of cardiac death or myocardial infarction(1 and 2 years)
- Target vessel revascularization (ischemia- and clinically-driven)(1 and 2 years)
- Target lesion revascularization (ischemia- and clinically-driven)(1 and 2 years)
- In-stent and in-segment late loss on angiographic follow-up(1 year)
- In-stent and in-segment restenosis rate(1 year)
- Incidence and angiographic pattern of restenosis(1 year)
- Canadian Cardiovascular Society Classification status(1 and 2 years)
研究者
Seung-Jea Tahk
MD
Ajou University School of Medicine
研究点 (8)
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