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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 | Clinical Trials | Clareo Health

RECRUITINGNA

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

A Comparison of Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention and Coronary-Artery Bypass Grafting in Patients With Diabetes and Three-Vessel Coronary Artery Disease: DEFINE-DM Trial (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)

NCT05831085•Duk-Woo Park, MD

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
•2. 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% \[48 mmol/mol\]).
•3. 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.
•4. 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

•1. Unprotected left main coronary artery disease.
•2. 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).
•3. Recent ST-elevation myocardial infarction(\<5 days prior to randomization).
•4. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
•5. Severe left ventricular dysfunction (ejection fraction \<30%).
•6. 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.
•7. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or prasugrel) for at least 6 months.
•8. Prior CABG.
•9. Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation.
•10. More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed.
+9 more criteria

Locations (27)

Palo Alto VA Medical Center

Palo Alto, California, United States

Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS)

Beijing, China

Second Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, China

Medanta - The Medicity

Gurugram, India

Fortis Escorts Heart Institute

New Delhi, India

Sarawak Heart Centre

Kota Samarahan, Malaysia

University Clinical Center of Serbia

Belgrade, Serbia

National Heart Centre Singapore (NHCS)

Singapore, Singapore

Daegu Catholic University Medical Center

Daegu, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Key Dates

Start Date

June 14, 2024

Primary Completion Date

June 1, 2027

Completion Date

December 1, 2027

Last Updated

December 30, 2025

Enrollment

1,500

ESTIMATED participants

Conditions

Coronary Artery Stenosis

Interventions

State-of-the-Art Percutaneous Coronary Intervention

PROCEDURE

standard CABG

PROCEDURE

Contacts

Jung-hee Ham, Project manager

CONTACT

82-2-3010-4728 cvcrc5@amc.seoul.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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