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Balloon vs stent: new hope for heart patients without permanent metal?

NCT ID NCT04893291

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a sirolimus-coated balloon works as well as a standard drug-eluting stent for opening narrowed heart arteries. About 1,820 adults with coronary artery disease will be randomly assigned to receive either the balloon or the stent during a routine angioplasty procedure. The main goal is to see if the balloon is non-inferior to the stent in preventing artery failure at one year.

What this could mean

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

Active substance
Sirolimus-coated balloon (Magic Touch) and everolimus-eluting stent
What this could lead to
If successful, this could offer a stent-free option for opening blocked heart arteries, potentially reducing long-term complications from permanent implants.
What could go wrong
This is a large but early-stage comparison; the balloon may not be as effective as the standard stent, and risks like artery re-narrowing or bleeding remain.

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 1,820 people

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

Started

Nov 2021

Expected to finish

Aug 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: * age \>18 years; * all patients with a clinical indication to Percutaneous Coronary Intervention (PCI) (stable coronary artery disease or acute coronary syndromes); * native coronary artery lesion in a vessel with diameter \>2.0 mm and ≦3.5 mm at visual estimation; * maximum lesion length: 50 mm. * informed consent to participate in the study. Exclusion Criteria: * patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus or contrast media, which cannot be adequately pre-medicated; * patients participating in another clinical study; * subject is a woman who is pregnant or nursing (pregnancy test, either urine or blood test must be performed within 7 days prior to the index procedure in woman of child-bearing potential, and must not commit to initiating a pregnancy for 12 weeks after implantation, using effective contraception); * creatinine clearance \<30 ml/min; * left ventricular ejection fraction \<30%; * life expectancy \<12 months; * ST-elevation myocardial infarction in the previous 48 hours; * visible thrombus at lesion site; * culprit lesion stenosis \>99% and/or Thrombolysis In Myocardial Infarction (TIMI) flow \<2; * target lesion/vessel with any of the following characteristics: * concomitant PCI at the same vessel with any device (vessels are considered: left anterior descending, circumflex or right coronary artery); * pre-dilatation of the target lesion not performed or not successful (residual stenosis \>30%); * severe calcification of the target vessel, at lesion site but also proximally; * highly tortuous vessel which could impair device delivery to the lesion site following Investigator's judgement; * previous stent implantation at target vessel (left anterior descending artery; circumflex artery; right coronary artery); * bifurcation lesion where side branch treatment is anticipated; * left main stem stenosis \>50%; * target lesion is in left main stem * Lesion is located within asaphenous vein graft

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary stenosis

As listed by the trial registrant

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

Coronary artery disease Coronary artery stenosis

Contacts and locations

Locations

  • 1st Military Institute of Medicine

    Lublin, Poland

  • A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli

    Palermo, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • Albert Schweitzer Hospital

    Dordrecht, Netherlands

  • Altnagelvin Area Hospital

    Londonderry, United Kingdom

  • Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"

    Palermo, Italy

  • Azienda Ospedaliera Universitaria Integrata

    Verona, Italy

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Roma, Italy

  • Bangladesh Specialized Hospital Lt

    Dhaka, Bangladesh

  • Centre Hospitalier de SaintMalo

    St-Malo, France

  • Clinica Polispecialistica San Carlo

    Paderno Dugnano, 20037, Italy

  • Clinique Louis Pasteur

    Essey-lès-Nancy, France

  • Clinique Saint-Hilaire

    Rouen, France

  • Erasmus University Medical Center

    Rotterdam, Netherlands

  • Fondazione Poliambulanza

    Brescia, 25124, Italy

  • Golden Jubilee National Hospital

    Clydebank, United Kingdom

  • Groupe Hospitalier de La Rochelle

    La Rochelle, France

  • Haga Hospital Els Borst

    The Hague, Netherlands

  • Heliodors Święcicki Clinical Univeristy Hospital, Ul

    Poznan, Poland

  • Hospital Alvaro Cunqueiro-University Hospital of Vigo

    Vigo, Spain

  • Hospital General Universitario de Ciudad Real (HGUCR)

    Ciudad Real, Spain

  • Hospital Queen Elizabeth II

    Kota Kinabalu, Malaysia

  • Hospital Santa Isabel R. Frei Cornélio

    Ubá, Brazil

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital Universitario Lucus Augusti (HULA)

    Lugo, Spain

  • Hospital Universitario Marqués de Valdecilla (HUMV)

    Santander, Spain

  • Hospital Universitario de Araba

    Vitoria-Gasteiz, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, Spain

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Brazil

  • Hospital de La Princesa

    Madrid, Spain

  • Hôpital Prive du Confluent, 4 Rue Éric Tabarly

    Nantes, France

  • INC (National Institute of Cardiology),

    Rio de Janeiro, Brazil

  • InCor (Heart Institute)

    São Paulo, Brazil

  • Institute Dante Pazzanese of Cardiology

    São Paulo, Brazil

  • Istituto clinico Sant'Ambrogio

    Milan, Italy

  • Jurong Park Medical Centre JPMC

    Bandar Seri Begawan, Brunei

  • Kurmitola General Hospital

    Dhaka, Bangladesh

  • LABAID Cardiac Hospital

    Dhaka, Bangladesh

  • Les Hôpitaux de Chartres, Hôpital Louis Pasteur

    Le Coudray, France

  • Maasstad Hospital

    Rotterdam, Netherlands

  • National Heart Foundation Hospital & Research Institute

    Dhaka, Bangladesh

  • National Institute of Cardiovascular Disease

    Dhaka, Bangladesh

  • OLVG Onze Lieve Vrouwe Gasthuis location East

    Amsterdam, Netherlands

  • Ospedale Civile Sant'Andrea

    La Spezia, Italy

  • Ospedale Policlinico San Martino

    Genova, Italy

  • Ospedale S. Antonio Abate

    Trapani, Italy

  • Ospedale San Giuseppe Moscati

    Aversa, Italy

  • Ospedale Sandro Pertini

    Roma, 00157, Italy

  • Policlinico Tor Vergata

    Roma, Italy

  • Ramathibodi Hospital, Mahidol University

    Bangkok, Thailand

  • St Bartholomew's Hospital

    London, United Kingdom

  • University Hospitals Birmingham

    Birmingham, United Kingdom

  • University Malaya Medical Centre (Teaching and Research Hospital)

    Kuala Lumpur, Malaysia

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