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Heart stent study tests if extra ultrasound imaging saves lives

NCT ID NCT07512778

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 ways to guide heart stent placement in people with acute coronary syndrome (unstable angina or heart attack). One method uses standard X-ray images (angiography), and the other adds an ultrasound probe inside the artery (IVUS) for more detail. About 1,500 participants will be randomly assigned to one of the two methods. The goal is to see if IVUS reduces the chance of heart-related death, heart attack, or the need for another procedure within two years.

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

Mar 2025

Expected to finish

Dec 2031

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 to 90 years

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. Patients 19 years of age or older 2. Patients with unstable angina pectoris, and acute MI including NSTEMI or STEMI. 3. Coronary artery disease defined as \>70% stenosis (reference vessel diameter 2.5 - 5.0 mm based on operator assessment) with identifiable culprit lesion indicated stent implantation 4. All lesions must be suitable for treatment with the Synergy stent system, or other Synergy platform iteration 5. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic 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. Age \>90 years 2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated. 3. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors 4. An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 6 m after the procedure. 5. Cardiogenic shock 6. Restenotic lesions 7. Compromised left ventricular dysfunction (LVEF \<30%) 8. At the time of screening, the subject has a malignancy that is not in remission 9. Non-cardiac co-morbidities with a life expectancy less than 1 year 10. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 11. Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write 12. Concern for inability of the patient to comply with study procedures and/or follow-up (e.g., alcohol or drug abuse) 13. Pregnancy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

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

    RECRUITING

    Seoul, Eunpyeong-gu, 03312, South Korea

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