Physiology As Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: the PREDICT Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 221
- 试验地点
- 2
- 主要终点
- Rate of Target Vessel Failure
研究概览
简要总结
The purpose of this study is to assess whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events than standard angiographic guidance.
详细描述
Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximal flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR value less than or equal to 0.80 is generally considered to be associated with myocardial ischemia.
FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. this ratio represents the potential decrease in coronary flow distal o the coronary stenosis. Recently, other physiology ratios called non-hyperemic ratios (NHPR) have been developed.
Both types of physiology measures (FFR and NHPR) have been increasingly used in cardiac catheterization laboratories as a diagnostic tool. They provide a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization. However, they are underutilized as tools for the assessment of success of coronary interventions.
The PREDICT study is a pilot study which aims to prospectively determine whether post-PCI physiology guidance is associated with better clinical outcomes than standard angiographic guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Any patient referred for diagnostic coronary angiography and / or possible PCI in native coronary vessels.
- •Successful (< 30% diameter stenosis and normal TIMI 3 flow post-stenting) and uncomplicated PCI
- •All treated lesions stented with drug-eluting stents (except side-branches of bifurcations)
排除标准
- •Lesion in saphenous vein or arterial grafts
- •Allergy to aspirin, thienopyridines or ticagrelor precluding treatment for 30 days
- •Sub-optimal PCI result ( >30% residual diameter stenosis and/or <TIMI3 flow) or peri-procedural complications
- •Acute ST-Elevation MI (culprit lesion)
结局指标
主要结局
Rate of Target Vessel Failure
时间窗: within 18 months after index PCI;
as the composite of cardiac death, lesion-related MI and target vessel revascularization
Rate of angina-related events
时间窗: within 18 months after index PCI;
defined as hospitalization for unstable angina and unsolicited medical visits for angina
次要结局
- Final post-PCI pressure ratio values according to lesion location and intervened vessels(Post-randomization after stent implantation (< 1 hour))
- Final post-PCI FFR values according to lesion location and intervened vessels(Post-randomization after stent implantation (< 1 hour))
- Final post-PCI dPR values according to lesion location and intervened vessels(Post-randomization after stent implantation (< 1 hour))
- Final post-PCI physiology pullback curves according to lesion location and intervened vessels(Post-randomization after stent implantation (< 1 hour))
- Rates of individual components of MACE(within 18 months of index procedure)
- Rates of unstable angina requiring hospitalization or unsolicited medical visits(within 18 months of index procedure)
研究者
Olivier F. Bertrand
Study Principal Investigator
Laval University