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NCT05831085 · ClinicalTrials.gov record · last posted 2026-06-24

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

Study acronym: DEFINE-DM
StatusRecruiting
PhaseNot applicable
Started2024-06-14
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from the ClinicalTrials.gov record
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).

Protocol amendment history 3 changes detected by DataLookout

2026-06-25
minor
Trial sites expanded: 27 → 39 locations
2026-06-25
critical
Primary completion pushed: 2027-06 → 2029-12-31
2026-06-25
minor
Completion pushed: 2027-12 → 2029-12-31
Trial Details
NCT Number NCT05831085
Lead Sponsor Duk-Woo Park, MD
Collaborators: CardioVascular Research Foundation, Korea
Conditions Coronary Artery Stenosis
Enrollment 1,500 participants
Start Date 2024-06-14
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-24