跳至主要内容
临床试验/NCT02797561
NCT02797561终止不适用

A Multicenter, Prospective Cohort to Evaluate the Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions

Seung-Jung Park18 个研究点 分布在 1 个国家目标入组 438 人开始时间: 2016年7月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
438
试验地点
18
主要终点
Target vessel failure

研究概览

简要总结

The purpose of this study is to evaluate the effect of FFR (Fractional flow reserve) guided Percutaneous Coronary Intervention in coronary tandem lesions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Tandem lesion evaluated by FFR
  • Written consent

排除标准

  • TIMI flow < 3
  • Grafted vessel
  • Left ventricular ejection fraction < 30%
  • Severe calcification and/or severe tortuosity
  • Uncontrolled coronary spasm
  • Life expectancy < 2 years
  • Planned high risk surgery
  • Pregnancy or breast-feeding

研究组 & 干预措施

Tandem lesion evaluated by FFR

干预措施: 5 year Follow-up (Other)

结局指标

主要结局

Target vessel failure

时间窗: 2 years

defined as composite event of cardiac death, non-fatal myocardial infarction, target vessel revascularization

次要结局

  • clinical predictors of events(5 years)
  • myocardial infarction(5 years)
  • Cardiac rehospitalization(5 years)
  • Cardiac death and myocardial infarction(5 years)
  • functional index(5 years)
  • all cause death(5 years)
  • cardiac death(5 years)
  • stroke(5 years)
  • angina(5 years)
  • complications with FFR(5 years)
  • target vessel revascularization(5 years)
  • target lesion revascularization(5 years)
  • death, myocardial lnfarction, revascularization(5 years)
  • stent thrombosis(5 years)
  • number of antianginal medications(5 years)

研究者

发起方
Seung-Jung Park
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seung-Jung Park

professor of medicine

Asan Medical Center

研究点 (18)

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