Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT05831085

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

Led by Duk-Woo Park, MD · Updated on 2025-12-30

1500

Participants Needed

27

Research Sites

180 weeks

Total Duration

On this page

Sponsors

D

Duk-Woo Park, MD

Lead Sponsor

C

CardioVascular Research Foundation, Korea

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 20 years of age or older with angina or evidence of myocardial ischemia
  • Diagnosis of type 2 diabetes requiring insulin or oral hypoglycemic drugs, or confirmed elevated blood glucose levels
  • Significant three-vessel coronary artery disease with at least 50% narrowing in each of three major vessels, excluding the left main artery
  • Suitable for either PCI or CABG as determined by the Heart Team
  • Ability and willingness to provide informed written consent and follow the study protocol and follow-up schedule
Not Eligible

You will not qualify if you...

  • Presence of unprotected left main coronary artery disease
  • Complex coronary anatomy or conditions making PCI unsuitable
  • Recent ST-elevation myocardial infarction within 5 days before randomization
  • Cardiogenic shock or need for mechanical or pharmacologic hemodynamic support
  • Severe left ventricular dysfunction with ejection fraction below 30%
  • Requirement for other cardiac or non-cardiac surgery besides allowed procedures
  • Inability or contraindication to take aspirin or P2Y12 inhibitors for at least 6 months
  • Previous coronary artery bypass graft surgery
  • Extremely calcified or tortuous vessels preventing imaging or physiology assessment
  • More than one major vessel chronically occluded (except one chronic total occlusion allowed)
  • Requirement or potential need for additional surgery within 1 year
  • End-stage renal disease requiring dialysis
  • Liver cirrhosis
  • Pregnancy or lactation
  • Medical conditions limiting life expectancy to less than 2 years
  • Participation in another investigational drug or device study without completed primary endpoint follow-up, except certain observational or academic trials as allowed by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

Palo Alto VA Medical Center

Palo Alto, California, United States, 94304

Not Yet Recruiting

2

Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS)

Beijing, China

Not Yet Recruiting

3

Second Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, China

Actively Recruiting

4

Medanta - The Medicity

Gurugram, India

Actively Recruiting

5

Fortis Escorts Heart Institute

New Delhi, India

Not Yet Recruiting

6

Sarawak Heart Centre

Kota Samarahan, Malaysia

Actively Recruiting

7

University Clinical Center of Serbia

Belgrade, Serbia

Not Yet Recruiting

8

National Heart Centre Singapore (NHCS)

Singapore, Singapore

Not Yet Recruiting

9

Daegu Catholic University Medical Center

Daegu, South Korea

Not Yet Recruiting

10

Keimyung University Dongsan Medical Center

Daegu, South Korea

Actively Recruiting

11

Yeungnam University Medical Center

Daegu, South Korea

Not Yet Recruiting

12

Chungnam National University Hospital

Daejeon, South Korea

Not Yet Recruiting

13

Konyang University Hospital

Daejeon, South Korea

Withdrawn

14

Gangneung Asan Hospital

Gangneung, South Korea

Not Yet Recruiting

15

Chonnam National University Hospital

Gwangju, South Korea

Actively Recruiting

16

National Health Insurance Service Ilsan Hospital

Ilsan, South Korea

Actively Recruiting

17

Gachon University Gil Hospital

Incheon, South Korea

Not Yet Recruiting

18

Dong-A Medical Center

Pusan, South Korea

Actively Recruiting

19

Asan Medical Center

Seoul, South Korea

Actively Recruiting

20

Hanyang University Seoul Hospital

Seoul, South Korea

Not Yet Recruiting

21

Samsung Medical Center

Seoul, South Korea

Actively Recruiting

22

SNU Boramae Medical Center

Seoul, South Korea

Not Yet Recruiting

23

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

Suwon, South Korea

Not Yet Recruiting

24

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

Uijeongbu-si, South Korea

Actively Recruiting

25

Ulsan University Hospital

Ulsan, South Korea

Actively Recruiting

26

National Taiwan University Hospital

Taipei, Taiwan

Not Yet Recruiting

27

Siriraj Hospital

Bangkok, Thailand

Actively Recruiting

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Research Team

J

Jung-hee Ham, Project manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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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 | DecenTrialz