Actively Recruiting
A Comparison of Imaging- and Physiology-Guided Percutaneous Coronary Intervention and Coronary-Artery Bypass Grafting in Patients With Diabetes and Three-Vessel Coronary Artery Disease
Led by Duk-Woo Park, MD · Updated on 2025-12-30
1500
Participants Needed
27
Research Sites
26 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
Researchers are comparing two advanced heart procedures for patients with type 2 diabetes and significant three-vessel coronary artery disease (CAD) that does not involve the left main artery. The study aims to evaluate outcomes between imaging- and physiology-guided percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in this group. This randomized trial is led by Dr. Duk-Woo Park and focuses on major heart and brain-related events over two years. Participants will receive either state-of-the-art PCI, which includes advanced imaging and physiological assessments, the use of modern drug-eluting stents, and optimal medical therapy including cardiovascular and anti-diabetic medications, or they will undergo standard CABG surgery. Treatments are designed specifically for patients with diabetes and complex three-vessel coronary artery disease. The trial randomly assigns participants to one of these two treatment groups. During the study, participants will be closely monitored for major adverse cardiac or cerebrovascular events over two years, with extended follow-up to five years assessing outcomes such as death, heart attacks, repeat procedures, stroke, bleeding, hospital stays, and quality of life measures. Regular evaluations will include changes in angina symptoms, medication use, and healthcare costs. This comprehensive monitoring aims to understand the long-term effects and cost-effectiveness of the two revascularization strategies.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Age 20 years or older with angina and/or evidence of myocardial ischemia
- Diagnosis of type 2 diabetes requiring insulin or oral diabetes medications, or confirmed elevated blood glucose levels
- Significant three-vessel coronary artery disease with 50% or greater narrowing in each of the three major vessels, excluding left main artery
- Agreement to follow the study protocol and schedule, with signed informed consent
You will not qualify if you...
- Unprotected left main coronary artery disease
- Complex coronary anatomy or other heart conditions making PCI unsuitable
- Recent ST-elevation myocardial infarction within 5 days prior to randomization
- Cardiogenic shock or need for mechanical/pharmacologic support
- Severe left ventricular dysfunction with ejection fraction below 30%
- Need for other cardiac or non-cardiac surgery except maze procedure or pulmonary vein isolation
- Inability or contraindication to take aspirin or P2Y12 inhibitors for at least 6 months
- Prior coronary artery bypass graft surgery
- Extremely calcified or tortuous vessels preventing imaging or physiology evaluation
- More than one major vessel with chronic total occlusion; one allowed
- Requirement for additional surgery within 1 year
- End-stage kidney disease needing replacement therapy
- Liver cirrhosis
- Pregnancy or breastfeeding
- Medical conditions with life expectancy less than 2 years
- Active participation in another investigational drug or device study not completed primary endpoint follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay up to 7 days
Participants receive either imaging- and physiology-guided percutaneous coronary intervention or coronary-artery bypass grafting to treat their three-vessel coronary artery disease with diabetes.
1 procedure visit and hospital stay
Duration - Up to 5 years
Participants are monitored for major cardiac events, quality of life, and medication use over time after treatment.
Regular visits at 1, 6, 12, 18, 24, 36, and 60 months
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
Research Team
J
Jung-hee Ham, Project manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here