跳至主要内容
临床试验/NCT02475291
NCT02475291已完成不适用

Clinical Usefulness of Fractional Flow Reserve Measurement for Significant Stenosis in Proximal Coronary Artery

Yonsei University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Agreement of diagnosis between FFR-documented ischemia and angiographically significant stenosis

研究概览

简要总结

Fractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary angiography to assess the potential of a coronary stenosis to induce myocardial ischemia. Recent ESC guidelines referred to the usefulness of FFR extensively when noninvasive stress imaging is contraindicated, non-diagnostic, or unavailable. However, FFR requires additional manipulation with maximal and stable hyperemia by intravenous adenosine. More routine use of FFR for all angiographically significant stenoses would add considerable time, cost, and complexity to each PCI procedure and might also increase the risk of catheter-related complications such as coronary dissection and perforation. Although the guideline mentioned that FFR may not be useful in very high grade lesions (angiographically >90%) which always have an FFR <0.80, it have not been revealed yet proper criteria to predict FFR <0.80 obtained by angiographic parameters including degree of stenosis, lesion location and vessel size. It would be valuable to find more precise criteria available by conventional angiography for discrimination of functional stenosis in way to reduce the risk of additional procedure. For the purpose, the investigators will perform FFR in the lesions with significant stenosis (>70% diameter stenosis by visual estimation) and compare the angiographic parameters and FFR values in the study.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients ≥ 19 years old
  • Typical angina
  • Stable or unstable angina pectoris
  • At least one or more major epicardial coronary arteries with significant stenosis (>70% diameter stenosis by visual estimation on angiogram) confined to the proximal portion of left anterior descending artery, left circumflex artery, or right coronary artery
  • Reference vessel diameter of target lesion ≥3.0 mm
  • Normal LV ejection fraction (≥50%) without wall motion abnormality by echocardiography

排除标准

  • Previous myocardial infarction
  • Previous coronary bypass graft surgery
  • Cardiogenic shock
  • Multiple lesions in the vessel of interest
  • Contraindication or hypersensitivity to adenosine or contrast media
  • Reduced coronary blood flow (TIMI flow grade <3) in the vessel of interest
  • Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
  • Pregnant women or women with potential childbearing
  • Inability to understand or read the informed content

结局指标

主要结局

Agreement of diagnosis between FFR-documented ischemia and angiographically significant stenosis

时间窗: 1day

Coronary lesions with FFR \<0.80 will be defined to be related with ischemia. Because all lesions in the study will be angiographically significant stenosis with DS \>70%, agreement of diagnosis between FFR-defined ischemia and angiographically significant stenosis will be obtained by the ratio of lesions with FFR \<0.80.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验