This study is to compare clinical outcomes between quantitative coronary angiography-guided anatomic complete revascularization and fractional flow reserve-guided physiologic complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention with drug eluting stent
Men or women between the ages of 19and older
Typical chest pain or objective evidence of myocardial ischemia suitable for PCI Significant lesions with a diameter stenosis of 50-90% in major epicardial coronary arteries ≥ 2.25 mm in diameter by visual estimation.
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.
Coronary lesions resulting in the expected inability to perform FFR (ex, severe tortuosity or extreme angulation of the vessels)
Chronic total occlusion
Failed PCI of severe stenotic (diameter stenosis > 90%) or ACS culprit lesions
Previous PCI within 6 months before the index procedure
Parallel
Percutaneous Coronary Intervention
Procedure/SurgeryPercutaneous Coronary Intervention
Number of Participants with death
Major adverse cardiac events are defined as all-cause death
Number of Participants with MI
Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.
Number of Participants with unplanned repeat revascularization
Unplanned repeat revascularization is defined as revascularization of any diseased coronary arteries ≥ 2.0 mm in diameter by QCA due to recurred angina with at least one of the following: (1) positive non-invasive test, (2) positive invasive physiologic test, or (3) presence of diameter stenosis ≥50% by QCA.
Number of Participants with death
Major adverse cardiac events are defined as all-cause death
Number of Participants with MI
Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.
Number of Participants with unplanned repeat revascularization
Unplanned repeat revascularization is defined as revascularization of any diseased coronary arteries ≥ 2.0 mm in diameter by QCA due to recurred angina with at least one of the following: (1) positive non-invasive test, (2) positive invasive physiologic test, or (3) presence of diameter stenosis ≥50% by QCA.
Number of Participants with bleeding
Major or minor bleeding according to definitions from TIMI
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Seung-Whan Lee, M.D., Ph.D.
Lead sponsor
Asan Medical Center
Sponsor institution
Biotronik Korea Co., Ltd
Collaborator
