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Heart showdown: stents vs. bypass surgery in diabetes patients

NCT ID NCT05831085

Disease control Sponsor: Duk-Woo Park, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two advanced heart procedures—stenting guided by imaging and blood flow tests (PCI) versus bypass surgery (CABG)—in 1,500 people with diabetes and three blocked coronary arteries. The goal is to see which approach better prevents major events like death, heart attack, or stroke. Participants are randomly assigned to one procedure, and both groups also receive modern medications for heart health and diabetes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Percutaneous coronary intervention (stenting) with imaging and physiology guidance, and coronary artery bypass grafting (bypass surgery)
What this could lead to
If this trial succeeds, it could show that modern stenting guided by advanced imaging is as good as or better than bypass surgery for people with diabetes and multiple blocked arteries, potentially offering a less invasive option.
What could go wrong
This is a large trial, but results may not apply to everyone with diabetes or heart disease. Both procedures carry risks like bleeding, infection, or heart attack, and the study is still recruiting, so outcomes are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 HbA1C ≥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: 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 (ejection fraction \<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. Contraindication 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 life expectancy of less than 2 years. 16. 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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary stenosis diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Bucheon Sejong Hospital

    RECRUITING

    Bucheon-si, South Korea

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, South Korea

  • Daegu Catholic University Medical Center

    NOT_YET_RECRUITING

    Daegu, South Korea

  • Dong-A Medical Center

    RECRUITING

    Pusan, South Korea

  • Fortis Escorts Heart Institute

    RECRUITING

    New Delhi, India

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

    RECRUITING

    Beijing, China

  • Gachon University Gil Hospital

    NOT_YET_RECRUITING

    Incheon, South Korea

  • Gangneung Asan Hospital

    NOT_YET_RECRUITING

    Gangneung, South Korea

  • Hanyang University Seoul Hospital

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Konyang University Hospital

    WITHDRAWN

    Daejeon, South Korea

  • Medanta - The Medicity

    RECRUITING

    Gurugram, India

  • Mody Harvard Cardiac Institute

    RECRUITING

    Bathinda, India

  • National Health Insurance Service Ilsan Hospital

    RECRUITING

    Ilsan, South Korea

  • National Heart Centre Singapore (NHCS)

    RECRUITING

    Singapore, Singapore

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan

  • Palo Alto VA Medical Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • Pauls Stradins Clinical University Hospital

    RECRUITING

    Riga, Latvia

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, South Korea

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • SNU Boramae Medical Center

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Sarawak Heart Centre

    RECRUITING

    Kota Samarahan, Malaysia

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hanzhou, China

  • Seoul university Bundang hospital

    RECRUITING

    Seongnam-si, South Korea

  • Siriraj Hospital

    RECRUITING

    Bangkok, Thailand

  • Siriraj Hospital

    RECRUITING

    Bangkok, Thailand

  • Srinagarind Hospital

    RECRUITING

    Khon Kaen, Thailand

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

    RECRUITING

    Seoul, South Korea

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

    NOT_YET_RECRUITING

    Suwon, South Korea

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

    RECRUITING

    Uijeongbu-si, South Korea

  • Tsuchiura Kyodo Hospital

    RECRUITING

    Tsuchiura, Japan

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • University Clinical Center of Serbia

    RECRUITING

    Belgrade, Serbia

  • Victorian Heart Institute

    RECRUITING

    Clayton, Australia

  • Vilnius University Hospital Santaros Klinikos

    RECRUITING

    Vilnius, Lithuania

  • Yeungnam University Medical Center

    NOT_YET_RECRUITING

    Daegu, South Korea

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