Multicenter Validation of 3D-QCA Based FFR vs. Pressure Wire Based FFR: The FAST-II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 6
- 主要终点
- Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by corelab
研究概览
简要总结
The Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective observational multicenter study designed to evaluate the diagnostic accuracy of offline 3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands) in identifying hemodynamically significant coronary artery disease with pressure wire-based FFR (≤0.80) as the reference standard.
详细描述
The Multicenter FAST study is a prospective observational multicenter international study in which offline computation of vFFR is compared to conventional invasive, wire based FFR measurements. Pressure wire based FFR will be performed in patients with at least one intermediate coronary lesion at the discretion of the operator (typically defined as a coronary artery lesion with a diameter stenosis of 30-70% by visual assessment). A total of 3 two-dimensional angiography images, will be recorded and exported to the CAAS workstation 8.0 (Pie Medical Imaging, Maastricht, the Netherlands): two orthogonal views to create a 3D reconstruction of the coronary arteries and one view to ascertain the position of the FFR pressure wire. vFFR will be calculated automatically, by using the invasively measured aortic root pressure. vFFR measurements will be performed online by the different centers. In addition, all angiographic imaging data will be sent to an independent core laboratory (Cardialysis, Rotterdam, The Netherlands) for offline analysis.
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 ≥ 18 years
- •indication procedure: stable, unstable angina or non-ST elevation acute coronary syndrome
- •Diagnostic coronary angiography or PCI with an indication to perform re-PCI FFR assessment of at least one coronary artery lesion.
排除标准
- •ST-elevation myocardial infarction (STEMI)
- •Cardiogenic shock
- •Severe hemodynamic instability
- •Adenosine intolerance
- •Lesions containing thrombus, left main lesions, grafts, arteries with collaterals
结局指标
主要结局
Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by corelab
时间窗: 1 year
The diagnostic accuracy of offline vFFR assessed by a blinded independent core laboratory to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or \>0.8) as the reference standard.
次要结局
- Interobserver variability(1 year)
- Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by site/operator(1 year)
研究者
Joost Daemen
Principal Investigator
Erasmus Medical Center