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Sound waves vs X-Rays: which guides heart stents better?

NCT ID NCT07616024

Disease control Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways to guide stent placement during emergency treatment for a severe type of heart attack (STEMI). About 2,500 patients will be randomly assigned to receive either standard X-ray guidance or ultrasound guidance (IVUS) during the procedure. The goal is to see if ultrasound guidance leads to fewer future heart-related events like death, repeat procedures, or another heart attack.

What this could mean

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

Active substance
Intravascular ultrasound (IVUS) procedure
What this could lead to
If successful, this could show that using ultrasound during emergency heart attack stenting reduces the risk of future heart problems or death.
What could go wrong
This is a large trial but still early in testing. The ultrasound guidance may not provide a clear benefit over standard care, and the procedure carries typical risks of catheter use.

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 2,488 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

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

18 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. Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) who have an indication for emergency interventional therapy; 2. Subjects who are eligible to undergo primary percutaneous coronary intervention (PCI); 3. Subjects or their authorized family members voluntarily agree to participate in the clinical trial and sign the written informed consent form; 4. The IVUS catheter is expected to pass through the target lesion to complete the examination. Exclusion Criteria 1. Patients with cardiogenic shock or severe heart failure (Killip class IV); 2. Patients who have previously undergone coronary artery bypass grafting (CABG); 3. Patients with coma or disturbance of consciousness; 4. Patients who are expected to be intolerant to long-term antiplatelet therapy; 5. Pregnant women; 6. Life expectancy \< 1 year; 7. Currently participating in another drug/device clinical trial and not having reached the primary endpoint; 8. Poor compliance, expected to be unable to complete follow-up.

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Conditions

The condition(s) this trial relates to.

ST-elevation myocardial infarction

As listed by the trial registrant

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

PCI STEMI

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

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032, China

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