CTRI/2024/08/073132尚未招募不适用
A Comparison of Fractional Flow Reserve- versus Angiography-Guided Percutaneous Coronary Intervention in Patients with Left Main Coronary Artery Disease: FATE-MAIN Trial (Fractional Flow Reserve versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease)
Dr. Seung-Jung Park1 个研究点 分布在 1 个国家目标入组 934 人开始时间: 2024年9月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 934
- 试验地点
- 1
- 主要终点
- Composite event of death from any causes, myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, or repeat revascularization at 2 years after randomization. Subjects who die or are lost to follow up before 2 years will be censored at their last recorded activity.
研究概览
简要总结
FATE-MAIN is an investigator-initiated, multicenter, international, randomized, controlled trial including up to 30 sites worldwide. Consecutive patients with significant LMCA disease who meet the inclusion criteria and none of the exclusion criteria outlined below will be randomized in a 1:1 fashion to either FFR-guided or angiography-guided PCI.
Patients with significant (as ≥50% diameter stenosis) LMCA stenosis undergoing PCI with drug-eluting stents (DES), routine measurement of FFR in addition to angiographic guidance, as compared with PCI guided by angiography alone, results in a significant reduction in major adverse cardiac events at 2 years, a finding that supports the evolving strategy of physiology-guided revascularization for ischemia-inducing LMCA lesions, but only medical therapy for non-ischemic LMCA lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •The subject must be more than or equal to 20 years of age with angina and/or evidence of myocardial ischemia
- •Significant de novo LMCA disease, defined as more than or equal to 50% diameter stenosis by visual estimation with or without concomitant non-left main major epicardial CAD, amenable to PCI with 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
- •LAD or LCX CTO(RCA CTO only allowed)
- •Extremely calcified or tortuous vessels precluding FFR measurement.
- •The presence of complex coronary disease anatomy or lesion characteristics or other cardiac conditions which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone)
- •Recent STEMI (Less than 7 Prior to randomization)
- •Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
- •Severe left ventricular dysfunction (ejection fraction less than 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 CABG
- •Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year
- •End-stage renal disease requiring renal replacement therapy
- •Liver cirrhosis
- •Women who are pregnant or breastfeeding or female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening
- •Concurrent medical condition with a limited life expectancy of less than 2 years 16.Patients 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 discretion
- •Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial
- •Screening failed before any interventional factor is involved
- •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.
结局指标
主要结局
Composite event of death from any causes, myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, or repeat revascularization at 2 years after randomization. Subjects who die or are lost to follow up before 2 years will be censored at their last recorded activity.
时间窗: 2 Years
次要结局
- Each individual component of primary composite outcome
- Death from any causes, cardiovascular causes, or noncardiovascular causes(2 Years)
- MI (any, spontaneous or procedural)(2 Years)
- Composite of death or MI(2 Years)
- Stent thrombosis (ARC definition)(2 Years)
- Stroke(2 Years)
- Bleeding complications (Bleeding Academic Research Consortium (BARC) type 3–5 indicates severe bleeding)(2 Years)
- Procedure time(1 day)
- Amount of contrast agent used(1 day)
- Length of hospital stay(an average of 7 day)
- Rehospitalization (any, cardiac, or noncardiac causes)(2 Years)
- Functional class (assessed by the CCS Classification) at each time point (discharge and follow up)(7 days(discharge) and 1, 6, 12, 24 months)
- Angina-related quality of life index (by the Seattle Angina Questionnaire)(7 days(discharge) and 1, 6, 12, 24 months)
- Health-related quality of life index (by the EQ-5D) at each time point (discharge and follow-up)(7 days(discharge) and 1, 6, 12, 24 months)
- Number of anti-anginal medications used at each time point (discharge and follow-up)(7 days(discharge) and 1, 6, 12, 24 months)
研究者
Dr Chadha Davinder Singh
Manipal Hospitals
研究点 (1)
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