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AI-Powered heart scans aim to prevent repeat surgeries

NCT ID NCT05807841

Disease control Sponsor: Asan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether using artificial intelligence (AI) to analyze ultrasound images during heart stent placement can reduce future heart problems. About 3,000 adults with coronary artery disease will receive a stent guided by AI-enhanced intravascular ultrasound. Researchers will track heart attacks, deaths, and the need for additional procedures over two years to see if the AI approach improves outcomes.

What this could mean

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

Active substance
IVUS-guided stent implantation
What this could lead to
If successful, this could show that AI-assisted imaging during stent placement reduces heart attacks, deaths, and the need for repeat procedures in people with coronary artery disease.
What could go wrong
This is a large but still early-stage study. The AI tools may not improve outcomes over standard care, and results may not apply to all heart patients. Risks include those typical of stent procedures, such as bleeding or vessel damage.

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.

Participants

About 3,000 people

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

Started

Feb 2020

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.

Who is studied

Between February 2020 and June 2027, a total of 3,000 patients who performe coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea.

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: * Age 19 years or older * Symptomatic angina patients with objective myocardial ischemia * Patients with at least one major epicardial coronary artery that requires stent implantation * Subject who signs with informed consent form Patient exclusion Criteria: * ST-segment elevation MI at admission * Patients who underwent coronary artery bypass surgery or heart transplantation * Left ventricular ejection fraction \<30% * Cardiogenic shock * Patients whose life expectancy \<2 years * Woman who are breastfeeding, pregnant or planning to become pregnant during study * Patients in whom anti-platelets or heparin is contraindicated Lesion exclusion Criteria: * Left main culprit lesion (angiographic diameter stenosis \>50%) * Thrombus-containing lesion * In-stent restenosis * Side branch lesion * Chronic total occlusion * Small vessel with reference diameter \<2.5mm * Coronary spasm despite administration of nitrate * Inability for imaging catheter to pass through tight stenosis, calcification, angulations * Poor image quality * Angiographically visible collateral vessels

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

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

    16 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

  • Chungnam National University Sejong Hospital

    RECRUITING

    Sejong, South Korea

  • Gangneung Asan Hospital

    RECRUITING

    Gangneung, South Korea

  • Gosin University Gospel Hospital

    RECRUITING

    Busan, South Korea

  • Gyeongsang National University Changwon Hospital

    RECRUITING

    Changwon, South Korea

  • Inje University Pusan Paik Hospital

    RECRUITING

    Busan, South Korea

  • Jesushospital

    RECRUITING

    Jeonju, South Korea

  • Kangbuk Samsung Medical Center

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Kangwon National University Hospital

    RECRUITING

    Chuncheon, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Seung-Whan Lee

    RECRUITING

    Seoul, 05505, South Korea

  • Soon Chun Hyang University Hospital Bucheon

    RECRUITING

    Bucheon-si, South Korea

  • The Catholic University of Korea ST.VINCENT'S Hospital

    RECRUITING

    Suwon, South Korea

  • The Catholic university of korea, Eunpyeong st. mary's hospital

    RECRUITING

    Seoul, South Korea

  • The Catholic university of korea, daejeon st. mary's hospital

    RECRUITING

    Daejeon, South Korea

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • Veterans Hospital Service Medical Center

    RECRUITING

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.