Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Simultaneous FFR measure SJM and ACIST
研究概览
简要总结
The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.
详细描述
The decision to perform a percutaneous coronary intervention (PCI) is usually based on angiographic results alone. Angiography can be used for the visual evaluation of the inner diameter of a vessel. Visual evaluation is limited by inter-individual variability.
Fractional flow reserve provides a functional evaluation, by measuring the pressure decline caused by a vessel narrowing.
The original studies validating the use of FFR were conducted with only one device (St-Jude Medical®). Recently, new FFR devices have been commercialized but have not yet been compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients hospitalized at Caen University Hospital for coronary angiography
- •Coronary stenosis needing FFR evaluation according to recommendations
- •More than 18 years old
- •Clinically stable
- •De novo coronary stenosis
- •Affiliated to social security
- •Informed consent signed
排除标准
- •Unstable patients defined by acute coronary syndrome < 7 days
- •Contre-indication to adenosine administration (asthma, allergy, high grade atrio-ventricular bloc without pace maker)
- •History of coronary artery bypass
- •intra-stent restenosis
- •Patient not capable of understanding the study
- •Informed consent not signed
结局指标
主要结局
Simultaneous FFR measure SJM and ACIST
时间窗: Immediately
Correlation between simultaneous measures with St Jude medical FFR device and ACIST device
Simultaneous FFR measure Boston Scientific and ACIST
时间窗: Immediately
Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device
Simultaneous FFR measure Boston Scientific and SJM
时间窗: Immediately
Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device
次要结局
- Clinical concordance(Immediately)
- FFR SJM or Boston alone versus simultaneous with ACIST(Immediately)
- Drift of the signal(immediately)