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Could a Drug-Coated balloon beat stents for a common heart attack cause?

NCT ID NCT07783880

Disease control Sponsor: 3W-Research Collaboration Group 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This study tests whether using a drug-coated balloon during a procedure to open a blocked artery is better than medication alone for treating plaque erosions, a common cause of heart attacks. About 62 adults who have had a heart attack and have plaque erosion will be randomly assigned to receive either the balloon procedure or standard medication. The trial will compare outcomes at 2 days and 1 year, using imaging to measure artery openness and tracking heart-related events.

What this could mean

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

Active substance
Drug-coated balloon (SeQuent) used during percutaneous coronary intervention (PCI), compared with medication (GP IIb/IIIa inhibitor or heparin plus dual antiplatelet therapy)
What this could lead to
If effective, this approach could offer a better, less invasive treatment for plaque erosions, potentially reducing the need for stents and improving recovery after a heart attack.
What could go wrong
This is a small pilot study, so results may not be conclusive. The procedure carries risks like any heart intervention, and the drug-coated balloon might not outperform standard medication.

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 62 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

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 aged ≥18 years presenting with MI where the culprit de-novo (stent restenosis/thrombosis excluded) lesion has a Thrombolysis in Myocardial Infarction (TIMI) flow of ≥ I with signs of thrombus on angiographic (or CCTA followed by conventional coronary angiography) evaluation located in a native coronary artery (a by-pass graft vessel excluded) addressable by PCI; 2. OCT criteria (all 4 should be present): 1. Presence of thrombus 2. Absence of an overt ruptured plaque flap 3. Area of stenosis of ≥ 50% 4. Presence of atherosclerotic, predominantly lipidic or fibrotic plaque underneath (absence of major calcifications or calcified noduli) Exclusion Criteria: 1. Culprit lesion located or extending in the Left Main coronary artery; 2. Presence of large coronary aneurysms; 3. Large thrombus burden (extending for more than \> 15 mm); 4. Patients with severe tortuous lesions (OCT judged not possible); 5. Spontaneous coronary dissection is suspected; 6. Renal insufficiency (Glomerular Filtration Rate (GFR) \< 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5); 7. Life expectancy less than 2 years; 8. Pregnant or lactating women; 9. Patients currently participating in another trial; 10. Patients that are unable or unwilling to provide consent; OCT exclusion criteria: 11. Overt plaque rupture; 12. Thrombosed protruding calcified noduli; 13. Predominantly calcific lesions with calcium arc \> 180° in the target segment; 14. Presence of calcium plaque of \> 0.4 mm thick;

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Conditions

The condition(s) this trial relates to.

myocardial infarction

As listed by the trial registrant

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

Computed tomography Coronary computed tomographic angiography Medical treatment Myocardial infarction Optical coherence tomography (OCT) Percutaneous coronary intervention (PCI)

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

  • Miedziowe Centrum Zdrowia SA

    Lubin, Poland

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