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New balloon could unclog failed heart stents without extra metal

NCT ID NCT04280029

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a special balloon coated with the drug sirolimus to treat in-stent restenosis, where a previously placed stent in a heart artery becomes blocked again. About 418 adults with this condition will be randomly assigned to receive either the drug-coated balloon or standard care (another stent or plain balloon). The main goal is to see if the new balloon is as safe and effective at preventing further heart problems within 12 months.

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 catheter
What this could lead to
If successful, this could offer a new, effective way to reopen blocked stents in heart arteries without needing another permanent stent.
What could go wrong
This is a mid-stage trial, so results are not yet proven. The balloon may not work as well as current treatments, and there are risks like artery damage or blood clots.

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

418 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Aug 2029

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.

Clinical Inclusion Criteria: 1. Subject age is ≥ 18 years or minimum legal age as required by local regulations. 2. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure. 3. Subject presents with chronic coronary syndrome (CCS) (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST-elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for percutaneous coronary intervention (PCI) and planned intervention. 4. Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either Clopidogrel, Prasugrel, or Ticagrelor. Note: Subjects who require continued oral anticoagulant therapy my omit aspirin at discretion of investigator. 5. Life expectancy \>1 year in opinion of investigator. 6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations. Angiographic Inclusion Criteria 1. Target lesion is within a native coronary artery or major branch. 2. Target lesion is within a previously placed BMS or DES and does not extend further than 5 mm beyond either the proximal or distal edge of the stent. 3. Up to two (2) non-target lesions in non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before treatment of the target lesion. Successful treatment is defined as no greater than 30% residual stenosis by visual estimate, no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C, and Thrombolysis in Myocardial Infarction (TIMI) grade flow in the non-target lesion \> 2. 4. Target lesion is ≤ 26 mm in length. 5. Target lesion has diameter stenosis of \> 50% and ≤ 99% by visual estimate. 6. Reference vessel diameter (RVD) is ≥ 2.00 mm and ≤ 4.50 mm. 7. Target lesion must be successfully pre-dilated/pre-treated. Note: Successful pre-dilation/pre-treatment is defined as dilation or pre-treatment that achieves stent expansion of approximately 80% of the distal RVD (at the discretion of the investigator) based on intravascular ultrasound (IVUS)/optical coherence tomography (OCT) and no greater than 30% residual stenosis by visual estimate and no dissection greater than NHLBI type C. TIMI grade flow in the target lesion must be \> 2. Note: Atherectomy and cutting balloon are permitted for pre-treatment. Clinical Exclusion Criteria: 1. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure. 2. ST-elevation myocardial infarction (STEMI) within 30 days. 3. Planned treatment of additional lesions in the target vessel, or more than two (2) non-target lesions within non-target vessels, during the index procedure. 4. Target lesion is located within a bifurcation with planned treatment of side branch vessel. 5. Target lesion is the 3rd or greater stent failure (i.e., more than two \[2\] layers of stent are present at any segment of the target lesion). 6. Target vessel had any previous vascular brachytherapy treatment or is planned to undergo brachytherapy at index procedure. 7. Previous PCI of the target vessel within 30 days. 8. Planned PCI of a non-target vessel, or a non-target lesion in the target vessel, within 30 days of randomization. 9. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m² within 30 days of index procedure) or has undergone renal transplantation. 10. Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output. 11. History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT. 12. Subject is pregnant, breast-feeding, or a woman of childbearing potential who is not using appropriate contraceptives to avoid becoming pregnant. 13. Documented left ventricular ejection fraction (LVEF) \< 25%. 14. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up. Angiographic Exclusion Criteria 1. Target lesion is a total occlusion or has evidence of thrombus. 2. Target lesion involves an unprotected left main. 3. Target lesion has \> 30% residual stenosis by visual estimate or dissection greater than NHLBI type C after pre-dilation/pre-treatment.

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Conditions

The condition(s) this trial relates to.

coronary restenosis

As listed by the trial registrant

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

Coronary restenosis

Contacts and locations

Locations

  • Amsterdam UMC, Academic Medical Centre

    Amsterdam, AZ, 1105, Netherlands

  • Ascension Borgess Heart Institute

    Kalamazoo, Michigan, 49048, United States

  • Ascension St John Hospital

    Southfield, Michigan, 48075, United States

  • Ascension St Vincents Heart Center

    Indianapolis, Indiana, 46260, United States

  • Ascension Via Christi

    Wichita, Kansas, 67226, United States

  • Atlanta VA Medical Center

    Atlanta, Georgia, 30033, United States

  • Baptist Cardiac & Vascular Institute

    Miami, Florida, 33176, United States

  • Baylor Scott & White

    Dallas, Texas, 75204, United States

  • Baylor Scott & White

    Temple, Texas, 76508, United States

  • Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

  • Beth Israel Deaconess Medical Centre, Harvard Medical School

    Boston, Massachusetts, 02215, United States

  • CHU Toulouse Rangueil

    Toulouse, 31400, France

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Center Azienda Ospedaliero Universitaria de Padova

    Padova, 35128, Italy

  • ClinRe 001-001

    Thornton, Colorado, 80023, United States

  • Clinique Saint Hilaire

    Rouen, 76000, France

  • Clinique Valmy

    Dijon, 21000, France

  • HCA Centennial

    Nashville, Tennessee, 37203, United States

  • HCA Chippenham/VA Cardiovascular Specialists

    Richmond, Virginia, 23225, United States

  • Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5, Canada

  • Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • HartCentrum Hasslet, Jessa Ziekenhuis

    Hasselt, Belgium

  • Hôpital privé Jacques Cartier

    Massy, 91300, France

  • Instituto Clinico Humanitas Milan

    Milan, 20089, Italy

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, São Paulo, 04012-180, Brazil

  • Instituto do Coração - São Paulo University

    São Paulo, São Paulo, 05403-900, Brazil

  • Integris

    Oklahoma City, Oklahoma, 73112, United States

  • Lifespan Cardiovascular Institute

    Providence, Rhode Island, 02903, United States

  • Loma Linda University

    Loma Linda, California, 92354, United States

  • Manchester Catholic Medical Center

    Manchester, New Hampshire, 03102, United States

  • Maria Cecilia Hospital

    Cotignola, 48033, Italy

  • MedStar Heart Institute

    Washington D.C., District of Columbia, 20010, United States

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina, 27401, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • NC Heart and Vascular Research, LLC

    Raleigh, North Carolina, 27607, United States

  • Pennsylvania State University Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Rutgers, Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • St. Francis Hospital & Heart Center

    Roslyn, New York, 11576, United States

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • UMC Utrecht

    Utrecht, CX, 3584, Netherlands

  • UMCG

    Groningen, GZ, 9718, Netherlands

  • UPMC Pinnacle Health

    Harrisburg, Pennsylvania, 17104, United States

  • University of Florida Health

    Jacksonville, Florida, 32209, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

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Other studies related to the condition(s) this trial covers.