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Balloon breakthrough: No-Stent fix for clogged heart arteries shows promise

NCT ID NCT05977842

Disease control Sponsor: National Institute of Cardiology, Warsaw, Poland 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a special balloon coated with medication to reopen completely blocked heart arteries in 309 people. The balloon delivers drug to keep the artery open without leaving a permanent stent. Researchers checked if the artery stayed open and if there were any heart problems within 6 months.

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.

Participants

309 people

The number who actually took part.

Started

Dec 2012

Finished

Jan 2025

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.

Who is studied

Consecutive patients with de novo CTO undergoing successful PCI with the use of DCB-only strategy.

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: * de novo coronary CTO undergoing successful recanalization with the use of DCB-only strategy at the occlusion site Exclusion Criteria: * de novo coronary CTO undergoing successful recanalization with the use of DES at the occlusion site * in-stent CTO

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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 Total occlusion of coronary artery

Contacts and locations

Locations

  • 1st Military Hospital

    Lublin, Poland

  • American Heart of Poland

    Bielsko-Biala, Poland

  • Bielanski Hospital

    Warsaw, Poland

  • Dr Alfred Sokolowski Specialist Hospital

    Wałbrzych, Poland

  • Emergency Clinical County Hospital

    Oradea, Romania

  • Graz University Heart Center

    Graz, Austria

  • Heart Institute

    Cluj-Napoca, Romania

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Spain

  • Hospital zum Heiligen Geist

    Kempen, Germany

  • Humanitas University

    Milan, Italy

  • Jagiellonian University Medical College

    Krakow, Poland

  • John Paul II Hospital

    Krakow, Poland

  • John Paul II Western Hospital

    Grodzisk Mazowiecki, Poland

  • Jolimont Hospital

    Uccle, Belgium

  • Kardiologické Centrum AGEL

    Pardubice, Czechia

  • Klinik Ottakring

    Vienna, Austria

  • Liberec Regional Hospital

    Liberec, Czechia

  • Lille University Hospital

    Lille, France

  • MSWiA Hospital

    Lodz, Poland

  • MSWiA Hospital

    Lublin, Poland

  • MSWiA Hospital

    Rzeszów, Poland

  • Medical University of Bialystok

    Bialystok, Poland

  • Military Institute of Medicine

    Warsaw, Poland

  • National Institute of Cardiology

    Warsaw, Poland

  • Poznan University of Medical Sciences

    Poznan, Poland

  • SP ZOZ Hospital

    Puławy, Poland

  • Santissima Annunziata Hospital

    Savigliano, Italy

  • Shamir Assaf Harofeh MC

    Be’er Ya‘aqov, Israel

  • Silesian Center for Heart Disease

    Zabrze, Poland

  • University Hospital Brno

    Brno, Czechia

  • University of Debrecen

    Debrecen, Hungary

  • University of Szeged

    Szeged, Hungary

  • Villa Sofia Hospital

    Palermo, Italy

  • Wroclaw Medical University

    Wroclaw, Poland

  • Županijska bolnica Čakovec

    Čakovec, Croatia

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