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New balloon treatment could rival standard stent for heart attacks

NCT ID NCT06746233

Disease control Sponsor: Institute of Cardiovascular Diseases, Vojvodina 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 if a drug-coated balloon works as well as the standard drug-coated stent for opening blocked arteries during a heart attack. About 600 adults having a severe type of heart attack (STEMI) will be randomly assigned to one of the two treatments. The goal is to see which approach better prevents heart-related death, another heart attack, or the need for repeat procedures.

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 598 people

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

Started

Dec 2024

Expected to finish

Dec 2028

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: * Age \>18 years with a life expectancy of \>1 year; * Patients fulfilling criteria for STEMI (\>20 min of chest-pain; At least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction confirmed by ECG or echocardiography; Reperfusion is expected to be feasible within 12 h after onset of symptoms) * Infarct related artery eligible for primary PCI (De novo lesion in a native coronary artery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severe calcification; Residual diameter stenosis of ≤30% (by visual assessment) after lesion preparation after lesion preparation; Absence of coronary dissection type ≥C. Exclusion Criteria: * Killip class\>II on admission * Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb/IIIa inhibitor * Previous myocardial infarction * Previous PCI in the territory of the infarct-related artery (IRA) * Previous CABG * 3-vessel disease requiring revascularization * Left-main disease * Extremely angulated or severely calcified vessels * History of ischemic stroke within the past 6 months or hemorrhagic stroke * Planned CABG for a non-culprit vessel * Participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study

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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.

ST-elevation myocardial infarction (stemi)

How to take part

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

  1. The places running it

    5 sites in 2 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 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

  • Institute of Cardiovascular Diseases of Vojvodina

    RECRUITING

    Kamenitz, 21204, Serbia

  • University Clinical Center of Kragujevac

    NOT_YET_RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Center of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • University Clinical Centre of Nis

    NOT_YET_RECRUITING

    Niš, Serbia, 18105, Serbia

  • University Clinical Centre of the Republic of Srpska

    RECRUITING

    Banja Luka, 21204, Bosnia and Herzegovina

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