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临床试验/NCT01414361
NCT01414361Unknown不适用

Comparison of Fractional Flow Reserve (FFR) and Minimal Luminal Area (MLA) by Intravascular Ultrasound (IVUS) in Evaluating Intermediate Coronary Artery Stenosis: International Multi-center Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
lumen area

研究概览

简要总结

Recent studies have shown that optimal IVUS criteria defining the functional significance (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate these results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

详细描述

Both physiologic information from fractional flow reserve (FFR) and anatomical information from intravascular ultrasound (IVUS) in assessing intermediate coronary stenotic lesions are useful. Functional significance of a coronary stenosis is determined by both the severity of a stenosis and the amount of myocardium supplied. Therefore, when the functional significance of a lesion is assessed by lumen area measured by IVUS, different criteria should be applied according to lesion location and anatomical variations of the coronary artery. However, previous studies included only patients with proximal lesions or small vessel disease, and the sample sizes were too small to assess these differences. In a recent study, the investigators have shown that optimal IVUS criteria defining the functional significance (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate the our results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Intermediate coronary stenosis by visual estimation

排除标准

  • history of coronary artery bypass graft surgery
  • previously revascularized lesion
  • creatinine > 1.6 mg/dL or eGFR < 30 ml/min/1.73m2 pre-procedure per institutional standards
  • known pregnancy
  • contrast agent allergy that cannot be adequately premedicated
  • severe PVD precluding cardiac catheterization
  • patient not a candidate for IVUS and FFR
  • inability or unwillingness to provide informed consent
  • inability or unwillingness to perform required follow up procedures

结局指标

主要结局

lumen area

时间窗: day 1

lumen area cut-off that can predict functional significance of a lesion

次要结局

  • angiographic stenosis, % plaque area(day 1)

研究者

申办方类型
Other

研究点 (1)

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