Pressure (Fractional Flow Reserve) and Flow (Vascular Flow Reserve) Measurements During Peripheral Arterial Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- TLF (Target lesion failure)
研究概览
简要总结
Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) have been originally developed for physiological assessment of coronary artery disease and may hold potential in the management of Peripheral Arterial Disease (PAD) as well. By adapting pressure and flow measurements for the peripheral arteries, clinicians could objectively evaluate stenosis severity, guiding treatment decisions and optimizing outcomes. The aim of this study is to evaluate the diagnostic performance of FFR and vascular Flow Reserve (VFR, aka CFR) for detection of functionally significant peripheral arterial disease and to derive appropriate cut-off values for the prediction of successful immediate and long-term clinical outcomes.
详细描述
Understanding Fractional Flow Reserve (FFR)
When it comes to diagnosing and managing coronary artery disease (CAD), medical advancements have introduced various tools and techniques to provide accurate assessments. One such critical method is Fractional Flow Reserve (FFR), a groundbreaking approach that aids physicians in making informed decisions regarding the necessity of coronary interventions.
What is Fractional Flow Reserve (FFR)?
Fractional Flow Reserve, commonly referred to as FFR, is a physiological index used to measure the severity of stenosis or narrowing in coronary arteries. It's a ratio of the maximum blood flow in a stenotic artery to the maximum blood flow if that artery if it were unobstructed. In simpler terms, FFR helps determine if a particular blockage in the coronary artery is significant enough to warrant intervention, such as angioplasty or stent placement.
How is FFR Measured?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symtpomatic peripheral arterial disease. Intermittent claudication or critical limb ischemia. Documented steno-occlusive disease of the femoropopliteal segment by imaging. Provision of informed consent form.
排除标准
- •Aortoiliac occlusive disease. Acute limb ischemia. Aneurysmal infrainguinal disease. General contra-indications to percutaneous ballon angioplasty and/or other endovascular procedures like dementia or bleeding diathesis.
结局指标
主要结局
TLF (Target lesion failure)
时间窗: 24 months
TLF (Target lesion failure) is defined as the composite of clinically driven TLR (Target lesion revascularization), acute limb ischemia or vascular amputation related to the target vessel. Target lesion is the segment where intervention was performed, and the length of the target lesion is inclusive of the arterial segment treated. Target vessel is the major native femoropopliteal axis or bypass graft containing the target lesion.
次要结局
- MALE (major adverse limb events)(24 months)
- MACE (major adverse cardiovascular events)(24 months)
研究者
Dr. Konstantinos Katsanos
Professor
University Hospital of Patras