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
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
- 否
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)
