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Recruiting NCT05829889

Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease

Trial Parameters

Condition Coronary Artery Disease Left Main
Sponsor Seung-Jung Park
Study Type INTERVENTIONAL
Phase N/A
Enrollment 960
Sex ALL
Min Age 20 Years
Max Age N/A
Start Date 2024-04-25
Completion 2027-06
Interventions
FFR-Guided PCIAngiography-Guided PCI

Brief 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).

Eligibility Criteria

Inclusion Criteria: 1. The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia. 2. 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. 3. 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: 1. left anterior descending coronary artery (LAD) or left circumflex coronary artery (LCx) chronic total occlusion (CTO) 2. Extremely calcified or tortuous vessels precluding FFR measurement. 3. 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 su

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