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Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD
RECRUITINGN/ASponsored by Seung-Whan Lee, M.D., Ph.D.
Actively Recruiting
PhaseN/A
SponsorSeung-Whan Lee, M.D., Ph.D.
Started2023-03-13
Est. completion2026-12-31
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05529459
Summary
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
Eligibility
Age: 19 Years+Healthy volunteers accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Previous coronary artery bypass graft surgery * Cardiogenic shock or hemodynamic instability * Left ventricular dysfunction (ejection fraction \< 35%) * Life expectancy \< 1 years for any non-cardiac or cardiac causes * Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure * A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer * Patient's pregnant or breast-feeding or child-bearing potential. * A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor) * Hypersensitivity or contraindication to DES material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated * Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study * Unwillingness or inability to comply with the procedures described in this protocol
Conditions2
Coronary DiseaseHeart Disease
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Actively Recruiting
PhaseN/A
SponsorSeung-Whan Lee, M.D., Ph.D.
Started2023-03-13
Est. completion2026-12-31
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05529459