Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD

Recruiting now · Not applicable

Conditions studied: Coronary Disease

In brief

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

Key facts

Study ID

NCT05529459

Run by

Seung-Whan Lee, M.D., Ph.D.

People needed

2400

Starts

2023-03-13

Expected to finish

2030-07-31

Last updated by the study team

2025-01-10

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Asan Medical Center — Seoul, South Korea (enrolling)
• Korea University Anam Hospital — Seoul, South Korea (enrolling)
• Veterans Hospital Service Medical Center — Seoul, South Korea (enrolling)
• Gyeongsang National University Changwon Hospital — Changwon, South Korea (enrolling)
• Chungbuk National University Hospital — Cheongju-si, South Korea (enrolling)
• Daegu Veterans Hospital — Daegu, South Korea (enrolling)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (enrolling)
• Gangneung Asan Hospital — Gangneung, South Korea (enrolling)
• Wonkwang University Hospital — Iksan, South Korea (enrolling)
• Kwangju Christian Hospital — Kwangju, South Korea (enrolling)
• Inje University Pusan Paik Hospital — Pusan, South Korea (enrolling)
• Inje University Busan Paik Hospital — Busan, South Korea (enrolling)
• Pusan National University Yangsan Hospital — Yangsan, South Korea
• Bucheon Sejong Hospital — Bucheon-si, South Korea
• Bundang CHA Hospital — Seongnam, South Korea
• The Catholic University of Korea, ST. Vincent's Hospital — Suwon, South Korea
• Hallym University Sacred Heart Hospital — Anyang, South Korea

Full record on ClinicalTrials.gov

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