Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease

Recruiting now · Not applicable

Conditions studied: Coronary Artery Stenosis

In brief

The objective of this randomized study was to compare outcomes of imaging-and physiology-guided state-of-the-art percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in patients with diabetes and three-vessel CAD (not involving left main).

Key facts

Study ID: NCT05831085
Run by: Duk-Woo Park, MD
People needed: 1500
Starts: 2024-06-14
Expected to finish: 2029-12-31
Last updated by the study team: 2026-06-24

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
Patients with type 2 diabetes based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level (fasting plasma glucose elevation on >1 occasion of ≥126 mg/dL [7.0 mmol/L] or 2-h postprandial of ≥200 mg/dL [11.1 mmol/L] during oral glucose tolerance test or random plasma glucose of ≥200 mg/dL [11.1 mmol/L] with classic symptoms of hyperglycemia or hyperglycemic crisis or HbA1C ≥6.5% [48 mmol/mol]).
Significant three-vessel CAD (defined as ≥ 50% diameter stenosis [DS] by visual estimation in each of the three major epicardial vessels or major side branches but not involving the left main coronary artery) and equivalently amenable to revascularization by means of either PCI or CABG as determined by the Heart Team at the trial site.
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…

Unprotected left main coronary artery disease.
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 suitable (i.e. the subject should be managed with CABG or medical therapy alone).
Recent ST-elevation myocardial infarction(<5 days prior to randomization).
Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
Severe left ventricular dysfunction (ejection fraction <30%).
Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, aorta surgery, or carotid revascularization). However, a maze procedure or pulmonary vein isolation is allowed.
Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or prasugrel) for at least 6 months.
Prior CABG.
Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation.
More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed.
Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
End-stage renal disease requiring renal replacement therapy.
Liver cirrhosis.
Pregnant and/or lactating women.
Concurrent medical condition with a limited life expectancy of less than 2 years.
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;
Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.
Screening failed before any interventional factor is involved.
Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.

Where it is running

Palo Alto VA Medical Center — Palo Alto, California, United States (enrolling)
Victorian Heart Institute — Clayton, Australia (enrolling)
Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS) — Beijing, China (enrolling)
Second Affiliated Hospital of Zhejiang University School of Medicine — Hanzhou, China (enrolling)
Queen Mary Hospital — Hong Kong, Hong Kong (enrolling)
Mody Harvard Cardiac Institute — Bathinda, India (enrolling)
Medanta - The Medicity — Gurugram, India (enrolling)
Fortis Escorts Heart Institute — New Delhi, India (enrolling)
Tsuchiura Kyodo Hospital — Tsuchiura, Japan (enrolling)
Pauls Stradins Clinical University Hospital — Riga, Latvia (enrolling)
Vilnius University Hospital Santaros Klinikos — Vilnius, Lithuania (enrolling)
Sarawak Heart Centre — Kota Samarahan, Malaysia (enrolling)
University Clinical Center of Serbia — Belgrade, Serbia (enrolling)
National Heart Centre Singapore (NHCS) — Singapore, Singapore (enrolling)
Bucheon Sejong Hospital — Bucheon-si, South Korea (enrolling)
The Catholic Univ. of Korea Seoul St. Mary's hospital — Seoul, South Korea (enrolling)
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital — Uijeongbu-si, South Korea (enrolling)
Ulsan University Hospital — Ulsan, South Korea (enrolling)
Pusan National University Yangsan Hospital — Yangsan, South Korea (enrolling)
National Taiwan University Hospital — Taipei, Taiwan (enrolling)
Siriraj Hospital — Bangkok, Thailand (enrolling)
Siriraj Hospital — Bangkok, Thailand (enrolling)
Srinagarind Hospital — Khon Kaen, Thailand (enrolling)
Keimyung University Dongsan Medical Center — Daegu, South Korea (enrolling)
Chungnam National University Hospital — Daejeon, South Korea (enrolling)

Full record on ClinicalTrials.gov

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