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Coronary Artery StenosisDEFINE-DMNCT05831085

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 study testing State-of-the-Art Percutaneous Coronary Intervention and standard CABG in people with Coronary Artery Stenosis, run by Duk-Woo Park, MD at 39 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Coronary Artery Stenosis
What is being tested?
State-of-the-Art Percutaneous Coronary Intervention and standard CABG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
39 sitesin 14 countries
Study dates
14 Jun 2024to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
  • 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 HbA1C ≥6.5% [48 mmol/mol]).
  • 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.
  • 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.

Who cannot join

  • Unprotected left main coronary artery disease.
  • 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).
  • Recent ST-elevation myocardial infarction(<5 days prior to randomization).
  • Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
  • Severe left ventricular dysfunction (ejection fraction <30%).
  • 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.
Show all 19Show fewer
  • Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or prasugrel) for at least 6 months.
  • Prior CABG.
  • Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation.
  • More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed.
  • Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
  • End-stage renal disease requiring renal replacement therapy.
  • Liver cirrhosis.
  • Pregnant and/or lactating women.
  • Concurrent medical condition with a limited life expectancy of less than 2 years.
  • Patients who are actively participating in another drug or device investigational 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.

Trial locations and contacts

39 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Jung-hee Ham, Project manager contact

82-2-3010-4728

cvcrc5@amc.seoul.kr

39 sites in 14 countries

South Korea21 sites, 20 recruiting

  • Bucheon Sejong Hospital

    Bucheon-si

    Young-jin Choi, MD

    Young-jin Choi, MD

    Recruiting

  • Daegu Catholic University Medical Center

    Daegu

    Jin-bae Lee, MD

    Jin-bae Lee, MD

    Not yet recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Chul-hyun Lee, MD

    Chul-hyun Lee, MD

    Recruiting

  • Yeungnam University Medical Center

    Daegu

    Woong Kim, MD

    Woong Kim, MD

    Not yet recruiting

  • Chungnam National University Hospital

    Daejeon

    Jin-ok Jeong, MD

    Jin-ok Jeong, MD

    Recruiting

  • Konyang University Hospital

    Daejeon

    Withdrawn

  • Gangneung Asan Hospital

    Gangneung

    Han-bit Park, MD

    Han-bit Park, MD

    Not yet recruiting

  • Chonnam National University Hospital

    Gwangju

    Young-keun Ahn, MD

    Young-keun Ahn, MD

    Recruiting

  • National Health Insurance Service Ilsan Hospital

    Ilsan

    Ji-yong Jang, MD

    Ji-yong Jang, MD

    Recruiting

  • Gachon University Gil Hospital

    Incheon

    Seung-hwan Han, MD

    Seung-hwan Han, MD

    Not yet recruiting

  • Dong-A Medical Center

    Pusan

    Yong-rak Cho, MD

    Yong-rak Cho, MD

    Recruiting

  • Seoul university Bundang hospital

    Seongnam-si

    Si-Hyuck Kang, MD

    Si-Hyuck Kang, MD

    Recruiting

  • Asan Medical Center

    Seoul

    Duk-woo Park, MD

    Duk-woo Park, MD

    Recruiting

  • Hanyang University Seoul Hospital

    Seoul

    Young-hyo Lim, MD

    Young-hyo Lim, MD

    Not yet recruiting

  • Samsung Medical Center

    Seoul

    Joo-yong Han, MD

    Joo-yong Han, MD

    Recruiting

  • SNU Boramae Medical Center

    Seoul

    Sang-hyun Kim, MD

    Sang-hyun Kim, MD

    Not yet recruiting

  • The Catholic Univ. of Korea Seoul St. Mary's hospital

    Seoul

    Byung-hee Hwang, MD

    Byung-hee Hwang, MD

    Recruiting

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

    Suwon

    Sung-ho Hur, MD

    Sung-ho Hur, MD

    Not yet recruiting

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

    Uijeongbu-si

    Hyo-seok Ahn, MD

    Hyo-seok Ahn, MD

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Eun-seok Shin, MD

    Eun-seok Shin, MD

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan

    Jeong-cheon Choi, MD

    Jeong-cheon Choi, MD

    Recruiting

Other trials in South Korea

India3 sites, 3 recruiting

  • Mody Harvard Cardiac Institute

    Bathinda

    Rohit Mody, MD

    Rohit Mody, MD

    Recruiting

  • Medanta - The Medicity

    Gurugram

    Rajneesh Kapoor, MD

    Rajneesh Kapoor, MD

    Recruiting

  • Fortis Escorts Heart Institute

    New Delhi

    Ashok Seth, MD

    Ashok Seth, MD

    Recruiting

Other trials in India

Thailand3 sites, 3 recruiting

  • Siriraj Hospital

    Bangkok

    Karokoth Towashiraporn, MD

    Karokoth Towashiraporn, MD

    Recruiting

  • Siriraj Hospital

    Bangkok

    Korakoth Towashiraporn, MD

    Korakoth Towashiraporn, MD

    Recruiting

  • Srinagarind Hospital

    Khon Kaen

    Chaiyasith Wongvipaporn, MD

    Chaiyasith Wongvipaporn, MD

    Recruiting

Other trials in Thailand

China2 sites, 2 recruiting

  • Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS)

    Beijing

    Kefei Dou, MD

    Kefei Dou, MD

    Recruiting

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    Hanzhou

    Jian'an Wang, MD

    Jian'an Wang, MD

    Recruiting

Other trials in China

United States1 site, 1 recruiting

  • Palo Alto VA Medical Center

    Palo Alto, California, 94304

    Fearon F. William, MD

    Fearon F. William, MD

    Recruiting

Other trials in United States

Australia1 site, 1 recruiting

  • Victorian Heart Institute

    Clayton

    James Sapontis, MD

    James Sapontis, MD

    Recruiting

Other trials in Australia

Hong Kong1 site, 1 recruiting

  • Queen Mary Hospital

    Hong Kong

    Frankie CC Tam, MD

    Frankie CC Tam, MD

    Recruiting

Other trials in Hong Kong

Japan1 site, 1 recruiting

  • Tsuchiura Kyodo Hospital

    Tsuchiura

    Tsunekazu Kakuta, MD

    Tsunekazu Kakuta, MD

    Recruiting

Other trials in Japan

Latvia1 site, 1 recruiting

  • Pauls Stradins Clinical University Hospital

    Riga

    Andrejs Erglis, MD

    Andrejs Erglis, MD

    Recruiting

Other trials in Latvia

Lithuania1 site, 1 recruiting

  • Vilnius University Hospital Santaros Klinikos

    Vilnius

    Giedrius Davidavicius, MD

    Giedrius Davidavicius, MD

    Recruiting

Other trials in Lithuania

Malaysia1 site, 1 recruiting

  • Sarawak Heart Centre

    Kota Samarahan

    Alan Fong, MD

    Alan Fong, MD

    Recruiting

Other trials in Malaysia

Serbia1 site, 1 recruiting

  • University Clinical Center of Serbia

    Belgrade

    Branko Beleslin, MD

    Branko Beleslin, MD

    Recruiting

Other trials in Serbia

Singapore1 site, 1 recruiting

  • National Heart Centre Singapore (NHCS)

    Singapore

    Tan Wei Chieh Jack, MD

    Tan Wei Chieh Jack, MD

    Recruiting

Other trials in Singapore

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital

    Taipei

    Paul Hsien Li Kao, MD

    Paul Hsien Li Kao, MD

    Recruiting

Other trials in Taiwan

About this study

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)

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).

Being tested
State-of-the-Art Percutaneous Coronary Intervention, standard CABG
Keywords
Multivessel Coronary Artery Disease, state of the art, State-of-the-Art Percutaneous Coronary Intervention, Coronary-Artery Bypass Grafting, Diabetes Mellitus
Medical subject headings
Coronary Stenosis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • State-of-the-Art Percutaneous Coronary InterventionProcedure or surgery

    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)

  • standard CABGProcedure or surgery

    Coronary-Artery Bypass Grafting

Study groups in NCT05831085
Study groupRoleWhat they receive
Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary InterventionExperimentalNot described
Receives: Procedure: State-of-the-Art Percutaneous Coronary Intervention
Coronary-Artery Bypass GraftingActive comparatorNot described
Receives: Procedure: standard CABG

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (19)

  1. The event rate of death from any cause

    Measured: 5 years

  2. The event rate of myocardial infarction

    Measured: 5 years

  3. The event rate of repeat revascularization

    Measured: 5 years

  4. The event rate of stroke

    Measured: 5 years

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

    Measured: 5 years

  6. The event rate of myocardial infarction

    any, spontaneous or procedural

    Measured: 5 years

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

    Measured: 5 years

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

    Measured: 5 years

  9. The event rate of stent thrombosis

    by an Academic Research Consortium (ARC) definition

    Measured: 5 years

  10. The event rate of symptomatic graft occlusion or stenosis

    Measured: 5 years

  11. The event rate of bleeding complications

    BARC (Bleeding Academic Research Consortium) criteria

    Measured: 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.

    Measured: 5 years

  13. Length of hospital stay

    Measured: 7 days

  14. The event rate of rehospitalization

    any, cardiac, or noncardiac causes

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 1, 12, 24, 36, 60 months

  18. The number of anti-anginal medications used

    Measured: 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.

    Measured: 1, 6, 12, 18, 24, 36, 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start14 Jun 2024
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05831085
Sponsor's protocol ID
AMCCV2023-03
Acronym
DEFINE-DM
Status last verified
Jun 2026
First submitted
4 Apr 2023
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing State-of-the-Art Percutaneous Coronary Intervention and standard CABG in people with Coronary Artery Stenosis, run by Duk-Woo Park, MD at 39 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in South Korea, India, Thailand, China, United States and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jung-hee Ham, Project manager (82-2-3010-4728, cvcrc5@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The event rate of major adverse cardiac or cerebrovascular events (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05831085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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