RecruitingNot ApplicableNCT05831085

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)


Sponsor

Duk-Woo Park, MD

Enrollment

1,500 participants

Start Date

Jun 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called State-of-the-Art Percutaneous Coronary Intervention and a procedure called standard CABG for people with coronary artery stenosis. The study is currently recruiting participants at 39 locations. People eligible for this study include aged 20 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREState-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)

PROCEDUREstandard CABG

Coronary-Artery Bypass Grafting


Locations(39)

Palo Alto VA Medical Center

Palo Alto, California, United States

Victorian Heart Institute

Clayton, Australia

Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS)

Beijing, China

Second Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, China

Queen Mary Hospital

Hong Kong, Hong Kong

Mody Harvard Cardiac Institute

Bathinda, India

Medanta - The Medicity

Gurugram, India

Fortis Escorts Heart Institute

New Delhi, India

Tsuchiura Kyodo Hospital

Tsuchiura, Japan

Pauls Stradins Clinical University Hospital

Riga, Latvia

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Sarawak Heart Centre

Kota Samarahan, Malaysia

University Clinical Center of Serbia

Belgrade, Serbia

National Heart Centre Singapore (NHCS)

Singapore, Singapore

Bucheon Sejong Hospital

Bucheon-si, South Korea

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

Seoul university Bundang hospital

Seongnam-si, 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 Univ. of Korea Seoul St. Mary's hospital

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

Pusan National University Yangsan Hospital

Yangsan, South Korea

National Taiwan University Hospital

Taipei, Taiwan

Siriraj Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Srinagarind Hospital

Khon Kaen, Thailand

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