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Balloons vs. stents: new trial aims to find best treatment for heart blockages

NCT ID NCT06551662

Disease control Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether drug-coated balloons work as well as drug-eluting stents for people with blocked heart arteries. About 321 participants will be randomly assigned to one of three treatments. The main goal is to see how well blood flows through the treated arteries after 6 to 9 months.

What this could mean

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

Active substance
Paclitaxel or Sirolimus drug-coated balloons, or drug-eluting stents
What this could lead to
If successful, this could show that drug-coated balloons are a safe and effective alternative to stents for certain types of heart blockages, potentially reducing the need for permanent metal implants.
What could go wrong
This is a mid-sized trial, and the results may not apply to all patients. There is a risk that balloons may not keep the artery as open as stents, and long-term outcomes are still unknown.

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 321 people

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

Started

Aug 2025

Expected to finish

Feb 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: * Subject must be age ≥18 years. * Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission. * Subject understands the trial design and treatment procedures and provides written informal consent before entering the trial * Subject is willing to comply with all protocol-required follow-up evaluations. * Target lesion must be native non-LM bifurcation lesion * Target lesion must be a bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, Medina 1,1,1 or Medina 0,0,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI). * Target lesion reference vessel diameter (both main vessel and side branch) * 2.0 mm by visual estimation. * Target lesion must have visually estimated stenosis ≥50%. * Target lesion length of side branch must be \<25 mm by visual estimation. Exclusion Criteria: * Patient with STEMI (within 3 days from the onset of chest pain to coronarography). * Patient has known allergy to the study balloon/stent system. * Patient has any other serious medical illness that may reduce life expectancy to less than 12 months. * Patient is pregnant or nursing. * Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure. * Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. * In-stent restenosis lesion. * Chronic total occlusion (CTO) lesion in either main vessel or side branch. * Left ventricular ejection fraction \<30%; * Visible and untreatable thrombus at lesion site; * Target lesion/vessel with any of the following characteristics: * Severe and/or \>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging); * Bifurcation lesion where stent strategy is anticipated; * Left main stem stenosis \>50%; * Target lesion is in the left main stem; * Lesions length \>50 mm (main vessel) * Lesions length \>25 mm (side branch)

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Conditions

The condition(s) this trial relates to.

collecting duct carcinoma coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease DCB

How to take part

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

  1. The places running it

    17 sites in 4 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

  • Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University

    NOT_YET_RECRUITING

    Wroclaw, Poland

  • Clinical Department of Interventional Cardiology, Medical University of Lublin

    NOT_YET_RECRUITING

    Lublin, Poland

  • Department of Cardiology

    NOT_YET_RECRUITING

    Wałbrzych, Poland

  • Department of Cardiology and Internal Diseases, Military Institute of Medicine

    NOT_YET_RECRUITING

    Warsaw, Poland

  • Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

    NOT_YET_RECRUITING

    Katowice, 40-635, Poland

  • Department of Cardiology, Copper Health Centre (MCZ)

    NOT_YET_RECRUITING

    Lubin, Poland

  • Department of Cardiology, Poznan University of Medical Sciences

    NOT_YET_RECRUITING

    Poznan, Poland

  • Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow

    NOT_YET_RECRUITING

    Rzeszów, Poland

  • Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland

    NOT_YET_RECRUITING

    Krakow, Poland

  • Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration

    NOT_YET_RECRUITING

    Warsaw, Poland

  • First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland

    NOT_YET_RECRUITING

    Gdansk, Poland

  • Fondazione Ricerca e Innovazione Cardiovascolare

    NOT_YET_RECRUITING

    Milan, Italy

  • Heart Institute, Cluj-Napoca

    RECRUITING

    Cluj-Napoca, Romania

  • Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland

    NOT_YET_RECRUITING

    Krakow, Poland

  • Sibiu County Emergency Clinical Hospital

    RECRUITING

    Sibiu, Romania

  • Tan Tock Seng Hospital

    NOT_YET_RECRUITING

    Singapore, Singapore

  • Third Department of Cardiology, Medical University of Katowice

    NOT_YET_RECRUITING

    Zabrze, Poland

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