Deferral of Angioplasty According to Fractional Flow Reserve vs. Routine Drug-eluting Stent Implantation in Intermediate Coronary Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Clinical event: Cardiac death, myocardial infarction, target lesion revascularization
研究概览
简要总结
Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow reserve-guided deferral strategy for these lesions showed the same event rate as routine intervention strategy. However, proper FFR criterion for these lesions in the era of drug-eluting stent is not known. This study sought to evaluate the clinical outcomes of intermediate lesions according to FFR and compare those of FFR-guided intervention with routine drug-eluting stent implantation strategy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective PCI
- •Angiographically intermediate stenosis (50-75% by visual estimation) in native major coronary arteries, proximal and mid (branch, distal lesion: exclusion)
- •Reference diameter > 2.5mm, lesion length < 60mm (cover by 2 stents)
- •No documented evidence of ischemia by noninvasive tests
排除标准
- •Acute ST elevation MI
- •Left main disease
- •Chronic renal failure (cr >2 mg/dL)
- •Expected survival < 2yrs
- •> 1degree AV block
研究组 & 干预措施
1
Fractional flow guided drug-eluting stent implantation arm
干预措施: Cypher, Taxus or Endeavor (Device)
2
Routine drug-eluting stent implantation
干预措施: Cypher, Taxus or Endeavor (Device)
结局指标
主要结局
Clinical event: Cardiac death, myocardial infarction, target lesion revascularization
时间窗: 9 months
次要结局
- IVUS(at the time of procedure)