A Comparison of Fractional Flow Reserve- Versus Angiography-Guided Percutaneous Coronary Intervention in Patients With Left Main Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 960
- 试验地点
- 64
- 主要终点
- The composite event rate
研究概览
简要总结
The primary purpose of the study was to determine whether the 2-year probability of major adverse cardiac events (primary composite outcome) differed significantly between patients who underwent angiography-guided Percutaneous Coronary Intervention(PCI) and those who underwent Fractional Flow Reserve(FFR)-guided PCI in patients with Left Main Coronary Artery disease(LMCA).
详细描述
All participants will be monitored over a span of two years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
- •Significant de novo LMCA disease, defined as ≥ 50% diameter stenosis by visual estimation with or without concomitant non-left main major epicardial coronary artery disease, amenable to PCI with drug-eluting stent(DES) implantation.
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •left anterior descending coronary artery (LAD) or left circumflex coronary artery (LCx) chronic total occlusion (CTO)
- •Extremely calcified or tortuous vessels precluding FFR measurement.
- •The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with coronary artery bypass graft or medical therapy alone).
- •Recent ST Elevation Myocardial Infarction(<7 days prior to randomization).
- •Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
- •Severe left ventricular dysfunction (ejection fraction <30%).
- •Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery).
- •Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel).
- •Prior PCI of the left main trunk.
- •Prior coronary artery bypass graft surgery.
- •Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
- •End-stage renal disease requiring renal replacement therapy.
- •Liver cirrhosis.
- •Pregnant and/or lactating women.
- •Concurrent medical condition with a limited life expectancy of less than 2 years.
- •Subjects who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;
- •1) Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.
- •2) Screening failed before any interventional factor is involved.
- •3) Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.
研究组 & 干预措施
FFR-guided Left Main PCI
干预措施: FFR-Guided PCI (Procedure)
Angiography-Guided PCI
干预措施: Angiography-Guided PCI (Procedure)
结局指标
主要结局
The composite event rate
时间窗: 2 years
Composite event consists of death from any causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, or repeat revascularization. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
次要结局
- The event rate of repeat revascularization(2 years)
- Functional class(7 days(discharge) and 1, 6, 12, 24 months)
- The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest(2 years)
- The event rate of stent thrombosis(2 years)
- Amount of contrast agent used(1 day)
- Change of health-related quality of life index(7 days(discharge) and 1, 6, 12, 24 months)
- The event rate of death from any causes(2 years)
- The event rate of stroke(2 years)
- Procedure time(1 day)
- Length of hospital stay(an average of 7 day)
- Change of angina-related quality of life index(7 days(discharge) and 1, 6, 12, 24 months)
- Number of anti-anginal medications(7 days(discharge) and 1, 6, 12, 24 months)
- The composite event rate of death or myocardial infarction(2 years)
- The event rate of myocardial infarction(2 years)
- The event rate of bleeding complications(2 years)
- The event rate of rehospitalization(2 years)
研究者
Seung-Jung Park
Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center
Asan Medical Center