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Could a balloon replace stents in young heart attack patients?

NCT ID NCT07229248

Disease control Sponsor: National Institute of Cardiovascular Diseases, Pakistan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 drug-coated balloon to a standard drug-eluting stent in 496 young adults (ages 18–50) having a heart attack. The balloon delivers medication to open the artery without leaving a permanent implant, which may reduce long-term risks like blood clots and the need for extended blood thinner use. Participants will be followed for one year to see if the balloon is as safe and effective as the stent.

What this could mean

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

Active substance
paclitaxel-coated balloon (Prevail DCB)
What this could lead to
If successful, this could offer young heart attack patients a stent-free option that lowers the risk of future heart problems and reduces the need for long-term blood thinners.
What could go wrong
This is a single-center trial, so results may not apply everywhere. The balloon might not keep the artery open as well as a stent, and there is a small risk of the artery closing suddenly during the procedure.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 496 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

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

18 to 49 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: * Either gender * Patient of age between 18 to 50 years * Patients with STEMI ( as first presentation of CAD) undergoing Primary PCI * Total ischemic Time less than 8 hrs. * Low syntax score * Stable (Killip I-II) Exclusion Criteria: * Patients with ESRD * Severe 3 VD; Intermediate of High syntax score * Lesion type\>B

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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.

Stemi (ST elevation mi)

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

  • National Institute of Cardiovascular Diseases

    RECRUITING

    Karachi, Pakistan

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