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Heart stent showdown: FFR vs. angiography for major artery blockage

NCT ID NCT05829889

Disease control Sponsor: Seung-Jung Park 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 two methods of guiding stent placement in the left main coronary artery: standard angiography versus fractional flow reserve (FFR), which measures blood pressure across the blockage. About 960 adults with significant left main artery disease will be randomly assigned to one method. The goal is to see which approach leads to fewer major heart problems—like heart attack, repeat procedures, or death—over two years.

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 (PCI) guided by either fractional flow reserve (FFR) or angiography
What this could lead to
If FFR-guided PCI proves better, it could become the standard approach for treating left main coronary artery disease, potentially reducing heart attacks and repeat procedures.
What could go wrong
This is a large but still early-stage comparison; results may show no significant difference between the two methods, and individual patient outcomes can vary. Risks of PCI include bleeding, infection, 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.

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 960 people

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

Started

Apr 2024

Expected to finish

Dec 2027

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. Significant de novo LMCA disease, defined as ≥ 50% diameter stenosis by visual estimation with or without concomitant non-left main major epicardial coronary artery disease, amenable to PCI with drug-eluting stent(DES) implantation. 3. 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. left anterior descending coronary artery (LAD) or left circumflex coronary artery (LCx) chronic total occlusion (CTO) 2. Extremely calcified or tortuous vessels precluding FFR measurement. 3. 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 coronary artery bypass graft or medical therapy alone). 4. Recent ST Elevation Myocardial Infarction(\<7 days prior to randomization). 5. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support. 6. Severe left ventricular dysfunction (ejection fraction \<30%). 7. Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery). 8. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel). 9. Prior PCI of the left main trunk. 10. Prior coronary artery bypass graft surgery. 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. Subjects 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

As listed by the trial registrant

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

Coronary artery disease Coronary artery disease (left main)

How to take part

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

  1. The places running it

    42 sites in 5 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. 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

  • Asan Medical Center

    RECRUITING

    Seoul, Songpa-gu, 138-736, South Korea

  • Bucheon Sejong Hospital

    RECRUITING

    Bucheon-si, South Korea

  • CHA Ilsan Medical Center

    TERMINATED

    Ilsan, South Korea

  • Changwon Gyeongsang National University Hospital

    RECRUITING

    Changwon, South Korea

  • Cheng Hsin General Hospital

    RECRUITING

    Taipei, Taiwan

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, South Korea

  • Chung-Ang University Gwangmyeong Hospital

    RECRUITING

    Gwangmyeong, South Korea

  • Chung-Ang University Hospital

    RECRUITING

    Seoul, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, South Korea

  • Chungnam National University Sejong Hospital

    RECRUITING

    Seongam, South Korea

  • Daegu Catholic University Medical Center

    RECRUITING

    Daegu, South Korea

  • Daejeon St. Mary's Hospital, Catholic University of Korea

    RECRUITING

    Daejeon, South Korea

  • Dong-A University Hospital

    RECRUITING

    Busan, South Korea

  • Eunpyeong St. Mary's Hospital, Catholic University of Korea

    RECRUITING

    Seoul, South Korea

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, South Korea

  • Gangneung Asan Hospital

    RECRUITING

    Gangneung, South Korea

  • Hallym University Dongtan Sacred Heart Hospital

    RECRUITING

    Hwaseong-si, South Korea

  • Hallym University Sacred Heart Hospital

    RECRUITING

    Anyang, South Korea

  • Hanyang University Hospital

    RECRUITING

    Seoul, South Korea

  • Ilsan Myongji Hospital

    TERMINATED

    Ilsan, South Korea

  • Inha University Hospital

    RECRUITING

    Incheon, South Korea

  • Inje University Ilsan Paik Hospital

    NOT_YET_RECRUITING

    Ilsan, South Korea

  • Japanese Red Cross Musashino Hospital

    RECRUITING

    Tokyo, Japan

  • Jeju National University Hospital

    TERMINATED

    Jeju City, South Korea

  • Kangbuk Samsung Hospital

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Kangwon National University Hospital

    RECRUITING

    Chuncheon, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Korea University Anam Hospital

    TERMINATED

    Seoul, South Korea

  • Korea University Ansan Hospital

    TERMINATED

    Ansan, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, South Korea

  • Kyung Hee University Hospital

    RECRUITING

    Seoul, South Korea

  • Manipal Hospital

    RECRUITING

    Bangalore, India

  • NTT East Japan Kanto Hospital

    WITHDRAWN

    Tokyo, Japan

  • National Health Insurance Service Ilsan Hospital

    RECRUITING

    Ilsan, South Korea

  • Princess Margret Hospital( HongKong)

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong

  • Pusan National University Hospital

    RECRUITING

    Busan, South Korea

  • Pusan National University Yangsan Hospital

    TERMINATED

    Busan, South Korea

  • Queen Mary Hospital

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong

  • Seoul Metropolitan Boramae Hospital

    RECRUITING

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Soonchunhyang University Seoul Hospital

    RECRUITING

    Seoul, South Korea

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

    RECRUITING

    Suwon, South Korea

  • Tsuchiura Kyodo General Hospital

    RECRUITING

    Tsuchiura, Japan

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • Yeouido St. Mary's Hospital, Catholic University of Korea

    RECRUITING

    Seoul, South Korea

  • Yeungnam University Hospital

    RECRUITING

    Daegu, South Korea

  • Yongin Severance Hospital

    RECRUITING

    Yongin, South Korea

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