NCT05716997已完成不适用
A PRospective Observational Study on the Relationship BEtween Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty: PROBE-FFR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Differences in fractional flow reserve (FFR) according to angiographic findings after coronary artery balloon angioplasty
研究概览
简要总结
The goal of this prospective observational study is to learn about in patients who need percutaneous coronary intervention for coronary artery disease. The main questions it aims to answer are:
- Fractional flow reserve according to coronary angiography findings after coronary artery balloon angioplasty
- Differences in fractional blood flow reserve before and after lesions between coronary balloon angioplasty using a scoring balloon and a regular balloon Participants will voluntarily consent to the study after being fully informed about the study and given ample opportunity to ask questions.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically stable coronary artery disease
- •Patients undergoing balloon angioplasty as an interventional procedure (FFR-guided PCI) using coronary artery fractional blood flow reserve for de novo lesions with a standard vessel diameter of 2.25 mm or more under percutaneous coronary angiography (hereafter referred to as coronary angiography)
- •(Note) If there are other lesions in the proximal area and the FFR of the distal lesion is collected, it is included in the selection target regardless of whether or not the proximal lesion was operated on.
排除标准
- •Target lesion with stenosis of less than 50% or greater than 90% of the internal diameter
- •Procedure for restenosis within the stent
- •Pre-dilation performed on the target lesion before the coronary artery fractional blood flow reserve test
- •Prior coronary artery bypass surgery
- •Clinically unstable or ST-segment elevation myocardial infarction
- •Myocardial infarction in the region supplied by the target vessel
- •Target vessel is a blood vessel that supplies collateral circulation for occlusion of other blood vessels (not applicable when the need for collateral circulation has been resolved due to the opening of another vessel occlusion)
- •Left ventricular ejection fraction (EF) less than 30%
- •Most recently measured eGFR is less than 30 right before the procedure
- •Accompanying primary valve disease requiring treatment
- •Accompanying primary heart disease such as dilated cardiomyopathy, hypertrophic cardiomyopathy, or restrictive cardiomyopathy
- •Congenital heart disease
结局指标
主要结局
Differences in fractional flow reserve (FFR) according to angiographic findings after coronary artery balloon angioplasty
时间窗: 15 minutes
Coronary angiographic findings and fractional flow within 15 minutes after coronary balloon angioplasty are collected and analyzed.
次要结局
- Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific attenuated plaque(1 year)
- Comparison of differences in fractional flow reserve (FFR) before and after lesions between coronary balloon angioplasty using a scoring balloon and a regular balloon(1 year)
- Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific minimum lumen area(1 year)
- 1-year outcome(1 year)
- Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific plaque burden(1 year)
- Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific positive remodeling(1 year)
研究者
Bon-Kwon Koo
Professor
Seoul National University Hospital
研究点 (2)
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