Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant L… (NCT05829889) | Clinical Trial Compass
RecruitingNot Applicable
Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease
Hong Kong, India, Japan960 participantsStarted 2024-04-25
Plain-language summary
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).
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).