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AI vs. invasive heart test: which is better for stenting?

NCT ID NCT07329699

Disease control Sponsor: Samsung Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new artificial intelligence (AI) method that uses X-ray images to guide heart artery stenting against the standard invasive method. About 2100 adults with narrowed heart arteries will be randomly assigned to one of the two approaches. The goal is to see if the AI method is as safe and effective at preventing major heart problems like heart attack or death.

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 2,100 people

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

Started

Mar 2026

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

19 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. Subject must be at least 19 years of age 2. Eligible for coronary angiography and/or percutaneous coronary intervention. 3. Chronic coronary syndrome or acute coronary syndrome (non-culprit vessels only) 4. Coronary artery disease in one or more native major epicardial vessels or their branches with reference vessel diameter of at least 2.5mm and with visually assessed coronary stenosis in which the physiological severity of the lesion is questionable (typically 40-90% diameter stenosis). 5. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily. Exclusion Criteria: 1. Patients unable to provide informed consent 2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents and drug-coated balloons 3. Patients with coronary artery bypass grafting 4. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year 5. Patients with cardiogenic shock or cardiac arrest 6. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 7. Patients with severe valvular heart disease requiring open heart surgery 8. Pregnant or lactating women 9. Angiographic exclusion criteria * Culprit vessel of patients with ST-elevation myocardial infarction (target lesions in non-culprit vessel can be enrolled) * Chronic total occlusion (target lesions in vessels without chronic total occlusion can be enrolled) * Ostial stenosis in left man coronary artery or right coronary artery * Severe tortuosity of any target vessel * Severe overlap in the stenosed segment * Poor image quality precluding identification of vessel contours

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder coronary stenosis

As listed by the trial registrant

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

Acute coronary syndrome Chronic coronary syndrome Coronary artery disease

How to take part

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

  1. The places running it

    23 sites. 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

  • Ajou University Hospital

    RECRUITING

    Suwon, South Korea

  • CHA Bundang Medical Center

    RECRUITING

    Gyeonggi-do, South Korea

  • Changwon Fatima Hospital

    RECRUITING

    Changwon, South Korea

  • Chonnam National University Hospital, Chonnam National University Medical School

    RECRUITING

    Gwangju, South Korea

  • Chung-Ang University Gwangmyeong Hospital

    RECRUITING

    Gwangmyeong, South Korea

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, South Korea

  • Gyeongsang National University Changwon Hospital

    RECRUITING

    Changwon, South Korea

  • Gyeongsang National University Hospital

    RECRUITING

    Jinju, South Korea

  • Inje University College of Medicine, Ilsan Paik Hospital

    RECRUITING

    Ilsan, South Korea

  • Inje University Haeundae Paik Hospital

    RECRUITING

    Busan, South Korea

  • International St. Mary's Hospital

    RECRUITING

    Incheon, South Korea

  • Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

    RECRUITING

    Seoul, South Korea

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, Select State, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, South Korea

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Boramae Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Uijeongbu ST. Mary's Hospital

    RECRUITING

    Uijeongbu-si, South Korea

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • Wonju Severance Christian Hospital

    RECRUITING

    Wŏnju, South Korea

  • Wonkwang University Hospital

    RECRUITING

    Iksan, South Korea

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