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Heart artery showdown: balloon vs. stent in major new trial

NCT ID NCT04859985

Disease control Sponsor: M.A. Med Alliance S.A. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two ways to treat coronary artery disease (blocked heart arteries). One uses a balloon coated with medicine (Selution DEB) to open the blockage, and the other uses a small mesh tube (stent) that also releases medicine (DES). About 3,300 adults with chest pain or recent heart attacks are taking part. The goal is to see which approach works better at preventing heart-related death, heart attacks, or the need for repeat procedures over 1 to 5 years.

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

3,326 people

The number who actually took part.

Started

May 2021

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

Subjects must meet all the following criteria to participate in the trial: * Subject age is ≥ 18 years (or 21 according to countries legal age) * Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure or are using a contraceptive device or drug. * Documented angina and/or positive functional testing or unstable angina or stabilized NSTEMI presentation. * Life expectancy \>1 year * Written informed consent by the subject or her/his legally authorized representative for participation in the study * One or more native target vessel (LAD, LCX or RCA) is considered to require intervention and is suitable for treatment of all lesions with either DEB + provisional stenting or with DES and is identified as such. * The number of trial target lesions is not limited, but in the operator's opinion, if the subject is randomized to the DEB arm, the likelihood of the subject requiring provisional stenting of any of the identified trial target lesions is \< 30%, and if randomized to the systematic DES arm, all lesions are considered amenable to stenting. * All target lesions: diameter between 2.0 and 5 mm, and diameter stenosis \>50% and \<100% with distal flow at least TIMI 2 Exclusion Criteria: Age \< 18 years (or 21 according to countries legal age) * Subject is pregnant or breast-feeding * Definite or suspected clinically active covid-19 infection * Subject is under judicial protection, tutorship or curatorship (for France only) * Subject is unable to fully comply with the study protocol * Contraindications to dual antiplatelet therapy, sirolimus or its analogues * Presentation with STEMI * Presentation with NSTEMI and ongoing chest pain or hemodynamic instability * Presentation with Killip III (pulmonary oedema) or IV (cardiogenic shock) * Chronic NYHA class III or IV heart failure prior to index PCI * Known LVEF \< 30% prior to index PCI * Previous PCI of a trial target vessel at any time * Previous PCI of a non-trial target vessel within 30 days * Trial target lesion located in the left main or any arterial or venous graft * Trial target lesion is chronic total occlusion (CTO) or in-stent restenosis (ISR) * Subject considered not able to tolerate at least 30 seconds of coronary occlusion for each trial target lesion * RVD of trial target lesion \> 5mm * Planned major surgery within one month following the procedure * Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease

Contacts and locations

Locations

  • Academic Teaching Hospital Feldkirch

    Feldkirch, Austria

  • Asklepios Kliniken GmbH & Co.

    Hamburg, Germany

  • BG Klinikum Unfallkrankenhaus Berlin

    Berlin, Germany

  • CH La Rochelle

    La Rochelle, France

  • CHU de Nîmes

    Nîmes, France

  • Centre Hospitalier de Pau

    Pau, France

  • Charite Campus Virchow Klinikum

    Berlin, Germany

  • Clinica Mediterranea

    Naples, Italy

  • Clinique Saint Hilaire

    Rouen, France

  • Elisabeth-Krankenhaus

    Essen, Germany

  • Glenfield Hospital

    Leicester, United Kingdom

  • Golden Jubilee National Hospital

    Glasgow, United Kingdom

  • HOCH Health Ostschweiz Kantonsspital St.Gallen

    Sankt Gallen, Switzerland

  • Herzklinikum Ulm

    Ulm, Germany

  • Herzzentrum Dresden GmbH Universitätsklinik

    Dresden, Germany

  • Hospital Alvaro Cunqueiro, University Hospital of Vigo

    Vigo, Spain

  • Hospital Clinico de Barcelona

    Barcelona, Spain

  • Hospital Universitario de La Princesa

    Madrid, Spain

  • Hôpital Cantonal de Fribourg

    Fribourg, Switzerland

  • Hôpital Européen Georges Pompidou

    Paris, France

  • Hôpital Jaques Cartier

    Massy, France

  • Johannes Wesling Klinikum Minden

    Minden, Germany

  • Kardiologisch-Angiologische Praxis • Herzzentrum Bremen

    Bremen, Germany

  • Kepler Universitätsklinikum GmbH

    Linz, Austria

  • Kliniczny Szpital Wojewódzki Nr. 2 w Rzeszowie

    Rzeszów, Poland

  • MEDICLIN Herzzentrum Lahr

    Lahr, Germany

  • Manchester University NHS Foundation Trust

    Manchester, United Kingdom

  • National Heart Centre Singapore (NHCS)

    Singapore, Singapore

  • Norfolk and Norwich University Hospitals

    Norwich, United Kingdom

  • Northern General, Sheffield

    Sheffield, United Kingdom

  • Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, Italy

  • Ospedale Sant'andrea

    Vercelli, Italy

  • Ospedale Santa Croce di Moncalieri

    Torino, Italy

  • RKH Kliniken Bruchsal Fürst Stirum Klinik

    Bruchsal, Germany

  • Royal Berkshire Hospital

    Reading, United Kingdom

  • Royal Infirmary of Edinburgh

    Edinburgh, United Kingdom

  • Royal Sussex County Hospital

    Brighton, United Kingdom

  • SIUN sote Hospital and Healthcare center

    Joensuu, Finland

  • SengKang General Hospital

    Singapore, Singapore

  • Szpital Kliniczny Przemienienia Pańskiego UM

    Poznan, Poland

  • Szpital Ministerstwa Spraw Wewnetrznych

    Rzeszów, Poland

  • Tergooi MC

    Hilversum, Netherlands

  • The Royal Bournemouth and Christchurch Hospitals

    Bournemouth, United Kingdom

  • Trent Cardiac Centre, Nottingham City Hospital

    Nottingham, United Kingdom

  • UMC Utrecht

    Utrecht, Netherlands

  • University Heart Center Graz

    Graz, Austria

  • University Hospital Basel

    Basel, Switzerland

  • University Hospital Brno

    Brno, Czechia

  • University Hospital Geneva (HUG)

    Geneva, Switzerland

  • University Hospital Ostrava

    Ostrava, Czechia

  • University Hospital Southampton

    Southampton, United Kingdom

  • University Hospital of Bern

    Bern, Switzerland

  • University Hospitals Bristol

    Bristol, United Kingdom

  • University Hospitals of North Midlands, Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

  • University Koeln

    Cologne, Germany

  • University Medical Center Amsterdam

    Amsterdam, Netherlands

  • University Medical Center Groningen

    Groningen, Netherlands

  • University Medical Center Hamburg Eppendorf

    Hamburg, Germany

  • University Zurich

    Zurich, Switzerland

  • Universitätsklinik Augsburg

    Augsburg, Germany

  • Universitätsklinikum Freiburg

    Bad Krozingen, Germany

  • Worcestershire Royal Hospital

    Worcester, United Kingdom

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