NCT05529459 Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD
| NCT ID | NCT05529459 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seung-Whan Lee, M.D., Ph.D. |
| Condition | Coronary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2023-03-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,400 participants in total. It began in 2023-03-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Seung-Whan Lee, Investigator
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT05529459 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Coronary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05529459 currently recruiting?
Yes, NCT05529459 is actively recruiting participants. Contact the research team at cvcrc22@amc.seoul.kr for enrollment information.
Where is the NCT05529459 trial being conducted?
This trial is being conducted at Anyang, South Korea, Bucheon-si, South Korea, Busan, South Korea, Changwon, South Korea and 11 additional locations.
Who is sponsoring the NCT05529459 clinical trial?
NCT05529459 is sponsored by Seung-Whan Lee, M.D., Ph.D.. The principal investigator is Seung-Whan Lee, Investigator at Asan Medical Center. The trial plans to enroll 2,400 participants.