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RecruitingNCT05831085DEFINE-DMUpdated Jun 24, 2026

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

An interventional study of State-of-the-Art Percutaneous Coronary Intervention and standard CABG in Coronary Artery Stenosis, sponsored by Duk-Woo Park, MD. Recruiting at 39 sites in 14 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Duk-Woo Park, MD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Coronary Artery Stenosis

Keywords

  • Multivessel Coronary Artery Disease
  • state of the art
  • State-of-the-Art Percutaneous Coronary Intervention
  • Coronary-Artery Bypass Grafting
  • Diabetes Mellitus
03

In context

Coronary Stenosis

326 studies on the registry are indexed under Coronary Stenosis; 57 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 190 across 191 interventional studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

Duk-Woo Park, MD is the lead sponsor of 15 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
  2. Patients with type 2 diabetes based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level (fasting plasma glucose elevation on >1 occasion of ≥126 mg/dL [7.0 mmol/L] or 2-h postprandial of ≥200 mg/dL [11.1 mmol/L] during oral glucose tolerance test or random plasma glucose of ≥200 mg/dL [11.1 mmol/L] with classic symptoms of hyperglycemia or hyperglycemic crisis or ≥6.5% [48 mmol/mol]).
  3. Significant three-vessel CAD (defined as ≥ 50% diameter stenosis [DS] by visual estimation in each of the three major epicardial vessels or major side branches but not involving the left main coronary artery) and equivalently amenable to revascularization by means of either PCI or CABG as determined by the Heart Team at the trial site.
  4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion criteria

Exclusion Criteria:

  1. Unprotected left main coronary artery disease.
  2. The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone).
  3. Recent ST-elevation myocardial infarction(\<5 days prior to randomization).
  4. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
  5. Severe left ventricular dysfunction ( \<30%).
  6. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, aorta surgery, or carotid revascularization). However, a maze procedure or pulmonary vein isolation is allowed.
  7. or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or prasugrel) for at least 6 months.
  8. Prior CABG.
  9. Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation.
  10. More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed.
  11. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
  12. End-stage renal disease requiring renal replacement therapy.
  13. Liver cirrhosis.
  14. Pregnant and/or lactating women.
  15. Concurrent medical condition with a limited of less than 2 years.
  16. Patients who are actively participating in another drug or device study, which have not completed the primary endpoint follow-up period. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;

1) Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.

2) Screening failed before any interventional factor is involved.

3) Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,500 participants (estimated)

Study arms

  • Experimental
    Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention

    Procedure: State-of-the-Art Percutaneous Coronary Intervention

  • Active comparator
    Coronary-Artery Bypass Grafting

    Procedure: standard CABG

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

06

What researchers measure

Primary outcomes

  1. The event rate of major adverse cardiac or cerebrovascular events

    Major adverse cardiac or cerebrovascular events (MACCE) were defined as a composite of hard clinical endpoints of death from any causes, myocardial infarction, or stroke.

    Time frame: 2 years

Secondary outcomes

  1. The event rate of death from any cause

    Time frame: 5 years

  2. The event rate of myocardial infarction

    Time frame: 5 years

  3. The event rate of repeat revascularization

    Time frame: 5 years

  4. The event rate of stroke

    Time frame: 5 years

  5. The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes

    Time frame: 5 years

  6. The event rate of myocardial infarction

    any, spontaneous or procedural

    Time frame: 5 years

  7. The event rate of composite of death or myocardial infarction

    Time frame: 5 years

  8. The event rate of composite of death, myocardial infarction, stroke or repeat revascularization

    Time frame: 5 years

  9. The event rate of stent thrombosis

    by an Academic Research Consortium (ARC) definition

    Time frame: 5 years

  10. The event rate of symptomatic graft occlusion or stenosis

    Time frame: 5 years

  11. The event rate of bleeding complications

    BARC (Bleeding Academic Research Consortium) criteria

    Time frame: 5 years

  12. The event rate of periprocedural major adverse events

    Periprocedural major adverse events means major arrhythmia, any unplanned surgery or therapeutic radiologic procedure, development of acute renal failure, sternal wound dehiscence, infection requiring antibiotics, prolonged intubation (\>48 hours), post-pericardiotomy syndrome, etc.

    Time frame: 5 years

  13. Length of hospital stay

    Time frame: 7 days

  14. The event rate of rehospitalization

    any, cardiac, or noncardiac causes

    Time frame: 7 days

  15. The change of functional class

    Assessed by The Canadian Cardiovascular Society (CCS) Angina Score Classification. The minimum and maximum values are 1 and 4 respectively. A higher score of CCS angina score classification means severe exertional angina.

    Time frame: 1, 6, 12, 18, 24, 36, 60 months

  16. The change of angina-related quality of life index by the Seattle Angina Questionnaire [SAQ]

    The SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains. The minimum and maximum values are 0 and 100 respectively. A lower score represents poor health status and a high score represents good health status.

    Time frame: 1, 12, 24, 36, 60 months

  17. The change of angina-related quality of life index by the EQ-5D

    EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group. The minimum and maximum values are 5 and 15 respectively. A higher score of EQ-5D means a low quality of life.

    Time frame: 1, 12, 24, 36, 60 months

  18. The number of anti-anginal medications used

    Time frame: 1, 6, 12, 18, 24, 36, 60 months

  19. Total healthcare costs and cost-effectiveness assessed using total medical expenditures and incremental cost-effectiveness ratio (ICER)

    Total medical cost will be calculated using predefined cost components related to the index revascularization procedure (PCI or CABG) and subsequent healthcare utilization. The list of cost items includes (but is not limited to): diagnostic catheters, guide catheters, guidewires, balloons, stents, adjunctive devices (e.g., rotablation system, intravascular lithotripsy), professional procedure fees, CABG-related graft categories, hospitalization cost per day (Intensive care unit and ward), and non-invasive cardiac tests. Total costs will be aggregated for each participant and compared between study groups at each scheduled time point. Cost-effectiveness will be assessed using the incremental cost-effectiveness ratio (ICER), calculated as the difference in total costs divided by the difference in clinical effectiveness between the study groups.

    Time frame: 1, 6, 12, 18, 24, 36, 60 months

07

Study locations

31 of 39 sites recruiting
  • Palo Alto VA Medical Center
    Palo Alto, California 94304, United States
    Recruiting
    • Fearon F. William, MD · Contact
    • Fearon F. William, MD · Principal investigator
  • Victorian Heart Institute
    Clayton, Australia
    Recruiting
    • James Sapontis, MD · Contact
    • James Sapontis, MD · Principal investigator
  • Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS)
    Beijing, China
    Recruiting
    • Kefei Dou, MD · Contact
    • Kefei Dou, MD · Principal investigator
  • Second Affiliated Hospital of Zhejiang University School of Medicine
    Hanzhou, China
    Recruiting
    • Jian'an Wang, MD · Contact
    • Jian'an Wang, MD · Principal investigator
  • Queen Mary Hospital
    Hong Kong, Hong Kong
    Recruiting
    • Frankie CC Tam, MD · Contact
    • Frankie CC Tam, MD · Principal investigator
  • Mody Harvard Cardiac Institute
    Bathinda, India
    Recruiting
    • Rohit Mody, MD · Contact
    • Rohit Mody, MD · Principal investigator
  • Medanta - The Medicity
    Gurugram, India
    Recruiting
    • Rajneesh Kapoor, MD · Contact
    • Rajneesh Kapoor, MD · Principal investigator
    • Praveen Chandra, MD · Principal investigator
  • Fortis Escorts Heart Institute
    New Delhi, India
    Recruiting
    • Ashok Seth, MD · Contact
    • Ashok Seth, MD · Principal investigator
  • Tsuchiura Kyodo Hospital
    Tsuchiura, Japan
    Recruiting
    • Tsunekazu Kakuta, MD · Contact
    • Tsunekazu Kakuta, MD · Principal investigator
  • Pauls Stradins Clinical University Hospital
    Riga, Latvia
    Recruiting
    • Andrejs Erglis, MD · Contact
    • Andrejs Erglis, MD · Principal investigator
  • Vilnius University Hospital Santaros Klinikos
    Vilnius, Lithuania
    Recruiting
    • Giedrius Davidavicius, MD · Contact
    • Giedrius Davidavicius, MD · Principal investigator
  • Sarawak Heart Centre
    Kota Samarahan, Malaysia
    Recruiting
    • Alan Fong, MD · Contact
    • Alan Fong, MD · Principal investigator
  • University Clinical Center of Serbia
    Belgrade, Serbia
    Recruiting
    • Branko Beleslin, MD · Contact
    • Branko Beleslin, MD · Principal investigator
  • National Heart Centre Singapore (NHCS)
    Singapore, Singapore
    Recruiting
    • Tan Wei Chieh Jack, MD · Contact
    • Tan Wei Chieh Jack, MD · Principal investigator
  • Bucheon Sejong Hospital
    Bucheon-si, South Korea
    Recruiting
    • Young-jin Choi, MD · Contact
    • Young-jin Choi, MD · Principal investigator
  • Daegu Catholic University Medical Center
    Daegu, South Korea
    Not yet recruiting
    • Jin-bae Lee, MD · Contact
    • Jin-bae Lee, MD · Principal investigator
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
    Recruiting
    • Chul-hyun Lee, MD · Contact
    • Chul-hyun Lee, MD · Principal investigator
  • Yeungnam University Medical Center
    Daegu, South Korea
    Not yet recruiting
    • Woong Kim, MD · Contact
    • Woong Kim, MD · Principal investigator
  • Chungnam National University Hospital
    Daejeon, South Korea
    Recruiting
    • Jin-ok Jeong, MD · Contact
    • Jin-ok Jeong, MD · Principal investigator
  • Konyang University Hospital
    Daejeon, South Korea
    Withdrawn

    Not enrolling at this site — choose another above.

  • Gangneung Asan Hospital
    Gangneung, South Korea
    Not yet recruiting
    • Han-bit Park, MD · Contact
    • Han-bit Park, MD · Principal investigator
  • Chonnam National University Hospital
    Gwangju, South Korea
    Recruiting
    • Young-keun Ahn, MD · Contact
    • Young-keun Ahn, MD · Principal investigator
  • National Health Insurance Service Ilsan Hospital
    Ilsan, South Korea
    Recruiting
    • Ji-yong Jang, MD · Contact
    • Ji-yong Jang, MD · Principal investigator
  • Gachon University Gil Hospital
    Incheon, South Korea
    Not yet recruiting
    • Seung-hwan Han, MD · Contact
    • Seung-hwan Han, MD · Principal investigator
  • Dong-A Medical Center
    Pusan, South Korea
    Recruiting
    • Yong-rak Cho, MD · Contact
    • Yong-rak Cho, MD · Principal investigator
  • Seoul university Bundang hospital
    Seongnam-si, South Korea
    Recruiting
    • Si-Hyuck Kang, MD · Contact
    • Si-Hyuck Kang, MD · Principal investigator
  • Asan Medical Center
    Seoul, South Korea
    Recruiting
    • Duk-woo Park, MD · Contact
    • Duk-woo Park, MD · Principal investigator
  • Hanyang University Seoul Hospital
    Seoul, South Korea
    Not yet recruiting
    • Young-hyo Lim, MD · Contact
    • Young-hyo Lim, MD · Principal investigator
  • Samsung Medical Center
    Seoul, South Korea
    Recruiting
    • Joo-yong Han, MD · Contact
    • Joo-yong Han, MD · Principal investigator
  • SNU Boramae Medical Center
    Seoul, South Korea
    Not yet recruiting
    • Sang-hyun Kim, MD · Contact
    • Sang-hyun Kim, MD · Principal investigator
  • The Catholic Univ. of Korea Seoul St. Mary's hospital
    Seoul, South Korea
    Recruiting
    • Byung-hee Hwang, MD · Contact
    • Byung-hee Hwang, MD · Principal investigator
  • The Catholic University of Korea, St. Vincent's Hospital
    Suwon, South Korea
    Not yet recruiting
    • Sung-ho Hur, MD · Contact
    • Sung-ho Hur, MD · Principal investigator
  • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
    Uijeongbu-si, South Korea
    Recruiting
    • Hyo-seok Ahn, MD · Contact
    • Hyo-seok Ahn, MD · Principal investigator
  • Ulsan University Hospital
    Ulsan, South Korea
    Recruiting
    • Eun-seok Shin, MD · Contact
    • Eun-seok Shin, MD · Principal investigator
  • Pusan National University Yangsan Hospital
    Yangsan, South Korea
    Recruiting
    • Jeong-cheon Choi, MD · Contact
    • Jeong-cheon Choi, MD · Principal investigator
  • National Taiwan University Hospital
    Taipei, Taiwan
    Recruiting
    • Paul Hsien Li Kao, MD · Contact
    • Paul Hsien Li Kao, MD · Principal investigator
  • Siriraj Hospital
    Bangkok, Thailand
    Recruiting
    • Karokoth Towashiraporn, MD · Contact
    • Karokoth Towashiraporn, MD · Principal investigator
  • Siriraj Hospital
    Bangkok, Thailand
    Recruiting
    • Korakoth Towashiraporn, MD · Contact
    • Korakoth Towashiraporn, MD · Principal investigator
  • Srinagarind Hospital
    Khon Kaen, Thailand
    Recruiting
    • Chaiyasith Wongvipaporn, MD · Contact
    • Chaiyasith Wongvipaporn, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Dec 2029, 66 months after the start.

Of 47 non-industry interventional studies with no phase under Coronary Stenosis, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 66. This study's planned 66 months is above that.

Counting every sponsor, half of 71 studies reached it within 26 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2023
First posted
Apr 26, 2023
StartActual
Jun 14, 2024
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2029
Last update
Jun 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05831085
Lead sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Duk-Woo Park, MD (Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center, Asan Medical Center) — Sponsor-investigator
First posted
Apr 26, 2023
Start date
Jun 14, 2024
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jun 24, 2026

Study contacts

Jung-hee Ham, Project manager
Contact
cvcrc5@amc.seoul.kr
82-2-3010-4728
Seung-jung Park, MD
study chair · Asan Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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