How Often Can Optimal Post Percutaneous Coronary Intervention (PCI) Fractional Flow Reserve (FFR) Results be Achieved? - a Randomised Controlled Trial of FFR Targeted PCI (the Target FFR Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- The proportion of patients with a final post-PCI FFR result ≥0.90
研究概览
简要总结
There has recently been renewed interest in the measurement of post percutaneous coronary intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that post-PCI FFR values ≥0.90 are associated with better clinical outcomes for patients but the available data suggest that despite angiographically satisfactory results, this is actually achieved in less than 40% of cases.
The main mechanisms for sub-optimal post-PCI FFR measurements have been proposed to be suboptimal stent deployment, unmasking of a second lesion in the target vessel post PCI, residual diffuse disease in the untreated segments and pressure drift (a technical artefact of pressure wire technology).
Using post-PCI FFR to guide stent optimisation and/or further intervention in the target vessel has been shown to increase the frequency of achieving optimal post-PCI FFR results (and therefore presumably better clinical outcomes). However, there are additional costs involved in the routine use of post-PCI FFR and it is not clear just how often it is even possible to increase the initial post-PCI FFR to ≥0.90. This uncertainty means that it is currently difficult to either recommend the routine use of post-PCI FFR or justify its cost.
The investigators propose a prospective study to assess the feasibility of achieving post-PCI FFR ≥0.90 during standard PCI procedures in consecutive patients. The study would also attempt to elucidate the mechanisms for sub-optimal FFR results when they occur. The investigators anticipate using the data from this developmental study to support a subsequent funding application for a definitive phase 3 study of the impact of FFR targeted PCI on clinical outcomes.
详细描述
Original hypothesis
A simple Physiology-guided Incremental Optimisation Strategy (PIOS) can increase the proportion of patients undergoing PCI in whom a post-PCI FFR ≥0.90 can be achieved from 40% to 60%.
Experimental details and design of proposed investigation
Overall aim:
A randomised controlled trial of a physiology-guided optimisation strategy to determine the feasibility of increasing the proportion of post-PCI FFR measurements ≥0.90 in a consecutive series of patients undergoing standard PCI procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Operator blinded pre and post PCI coronary physiology measurements will be performed in both arms of the study.
Post-PCI FFR results <0.90 in the interventional arm will be disclosed to the operator to allow further intervention
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 of age with coronary artery disease (including stable angina and stabilised non-ST-elevation myocardial infarction (NSTEMI)) who are able to provide informed consent.
排除标准
- •PCI in a coronary artery bypass graft
- •PCI to an in-stent restenosis (ISR) lesion
- •PCI to a target artery providing Rentrop grade 2 or 3 collateral blood supply to another vessel
- •Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker).
- •Recent (within 1 week prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
- •Severe cardiomyopathy (ejection fraction <30%).
- •Renal insufficiency such that an additional 20 to 30 mL of contrast would, in the opinion of the operator, pose unwarranted risk to the patient.
结局指标
主要结局
The proportion of patients with a final post-PCI FFR result ≥0.90
时间窗: 1 day
The proportion of patients with a final post-PCI FFR result ≥0.90 will be compared between the randomised groups
次要结局
- The proportion of patients with final post-PCI FFR ≤0.80(1 day)
- Change from baseline in self-reported health outcomes at 3 months using a generic quality of life measurement tool.(3 months)
- The rate of target vessel failure (TVF) and its component features at 1 year.(1 year)
- Change from baseline in the Resting Full-Cycle Ratio (RFR) following PCI(1 day)
- The proportion of patients with final post-PCI IMR >25(1 day)
- The proportion of patients with final post-PCI IMRc >25(1 day)
- Contrast Material Dose(1 day)
- Change from baseline in self-reported health outcomes at 3 months using a disease-specific quality of life measurement tool.(3 months)
- The rate of target vessel failure (TVF) and its component features at 3 months.(3 months)
- The proportion of patients with final post-PCI dPR ≥0.90(1 day)
- The proportion of patients with final post-PCI RFR ≥0.90(1 day)
- Change from baseline in the FFR following PCI(1 day)
- Change from baseline in the Diastolic Pressure Ratio (dPR) following PCI(1 day)
- The proportion of patients with final post-PCI CFR value ≥2.0(1 day)
- Change from baseline in the Coronary Flow Reserve (CFR) following PCI(1 day)
- The cost of additional equipment employed in the experimental arm(1 day)
- Change in TTrest following PCI(1 day)
- Change in TThyp following PCI(1 day)
- Change from baseline in the Index of Microcirculatory Resistance (IMR) following PCI(1 day)
- Procedure Duration(1 day)
- Fluoroscopy Dose(1 day)
- Incidence of procedural complications such as coronary artery dissection or perforation.(1 day)
研究者
Prof. Keith G. Oldroyd
Principal Investigator
NHS National Waiting Times Centre Board