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RECRUITING
NCT05831085
NA

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

Sponsor: 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).

Official title: 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)

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2024-06-14

Completion Date

2027-12

Last Updated

2025-12-30

Healthy Volunteers

No

Interventions

PROCEDURE

State-of-the-Art Percutaneous Coronary Intervention

supported by intracoronary imaging (e.g., intravascular ultrasound \[IVUS\] or optical coherence tomography \[OCT\]), intracoronary physiology (e.g., fractional flow reserve \[FFR\] or instantaneous wave-free ratio \[iFR\]), contemporary metallic DES (durable polymer everolimus-eluting stents; XIENCE family stent system, Abbott Vascular), guideline-directed optimal medical therapy \[GDMT\] with advanced cardiovascular (e.g., high-dose statin and advanced strategy of antiplatelet regimens) and anti-diabetic medications \[e.g., a sodium-glucose cotransporter \[SGLT\]-2 inhibitors or Glucagon-like peptide-1 \[GLP-1\] agonists) in patients with type 2 diabetes and three-vessel coronary artery disease (CAD) (not involving left main)

PROCEDURE

standard CABG

Coronary-Artery Bypass Grafting

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

Yeungnam University Medical Center

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Konyang University Hospital

Daejeon, South Korea

Gangneung Asan Hospital

Gangneung, South Korea

Chonnam National University Hospital

Gwangju, South Korea

National Health Insurance Service Ilsan Hospital

Ilsan, South Korea

Gachon University Gil Hospital

Incheon, South Korea

Dong-A Medical Center

Pusan, South Korea

Asan Medical Center

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

SNU Boramae Medical Center

Seoul, South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, South Korea

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Uijeongbu-si, South Korea

Ulsan University Hospital

Ulsan, South Korea

National Taiwan University Hospital

Taipei, Taiwan

Siriraj Hospital

Bangkok, Thailand