New balloon could unclog failed heart stents without extra metal
NCT ID NCT04280029
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Amsterdam UMC, Academic Medical Centre
Amsterdam, AZ, 1105, Netherlands
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Ascension Borgess Heart Institute
Kalamazoo, Michigan, 49048, United States
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Ascension St John Hospital
Southfield, Michigan, 48075, United States
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Ascension St Vincents Heart Center
Indianapolis, Indiana, 46260, United States
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Ascension Via Christi
Wichita, Kansas, 67226, United States
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Atlanta VA Medical Center
Atlanta, Georgia, 30033, United States
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Baptist Cardiac & Vascular Institute
Miami, Florida, 33176, United States
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Baylor Scott & White
Dallas, Texas, 75204, United States
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Baylor Scott & White
Temple, Texas, 76508, United States
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Beaumont Hospital
Royal Oak, Michigan, 48073, United States
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Beth Israel Deaconess Medical Centre, Harvard Medical School
Boston, Massachusetts, 02215, United States
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CHU Toulouse Rangueil
Toulouse, 31400, France
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Center Azienda Ospedaliero Universitaria de Padova
Padova, 35128, Italy
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ClinRe 001-001
Thornton, Colorado, 80023, United States
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Clinique Saint Hilaire
Rouen, 76000, France
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Clinique Valmy
Dijon, 21000, France
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HCA Centennial
Nashville, Tennessee, 37203, United States
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HCA Chippenham/VA Cardiovascular Specialists
Richmond, Virginia, 23225, United States
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Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5, Canada
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Harbor-UCLA Medical Center
Torrance, California, 90502, United States
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HartCentrum Hasslet, Jessa Ziekenhuis
Hasselt, Belgium
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Hôpital privé Jacques Cartier
Massy, 91300, France
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Instituto Clinico Humanitas Milan
Milan, 20089, Italy
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Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-180, Brazil
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Instituto do Coração - São Paulo University
São Paulo, São Paulo, 05403-900, Brazil
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Integris
Oklahoma City, Oklahoma, 73112, United States
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Lifespan Cardiovascular Institute
Providence, Rhode Island, 02903, United States
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Loma Linda University
Loma Linda, California, 92354, United States
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Manchester Catholic Medical Center
Manchester, New Hampshire, 03102, United States
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Maria Cecilia Hospital
Cotignola, 48033, Italy
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MedStar Heart Institute
Washington D.C., District of Columbia, 20010, United States
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Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
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Morristown Medical Center
Morristown, New Jersey, 07960, United States
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Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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NC Heart and Vascular Research, LLC
Raleigh, North Carolina, 27607, United States
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Pennsylvania State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
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Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
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St. Francis Hospital & Heart Center
Roslyn, New York, 11576, United States
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Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
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The Christ Hospital
Cincinnati, Ohio, 45219, United States
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UMC Utrecht
Utrecht, CX, 3584, Netherlands
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UMCG
Groningen, GZ, 9718, Netherlands
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UPMC Pinnacle Health
Harrisburg, Pennsylvania, 17104, United States
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University of Florida Health
Jacksonville, Florida, 32209, United States
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University of Maryland
Baltimore, Maryland, 21201, United States