New balloon treatment for blocked leg arteries put to the test
NCT ID NCT04475783
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of drug-coated balloons used to open blocked arteries in the leg. About 478 people with peripheral artery disease will receive either a sirolimus-coated balloon or a paclitaxel-coated balloon. The goal is to see if the sirolimus balloon works as well as the standard paclitaxel balloon at keeping arteries open after 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 catheter
What this could lead to
If successful, this could offer an alternative treatment for leg artery blockages that avoids the need for surgery.
What could go wrong
This is a non-inferiority trial, so it only aims to show sirolimus is not worse than paclitaxel, not that it is better. Results may not apply to all patients or lesions.
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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DIAKO Krankenhaus gGmbH, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie
Flensburg, 24939, Germany
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Elblandklinikum Radebeul, Gefäßzentrum
Radebeul, 01445, Germany
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Fürst-Stirum-Klinik Bruchsal, Klinik für Kardiologie, Angiologie, Diabetologie, Neurologie und Intensivmedizin
Bruchsal, 76646, Germany
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Hanusch-Krankenhaus
Vienna, 1140, Austria
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Helios Klinikum Krefeld, Institut für Diagnostische und Interventionelle Radiologie
Krefeld, 47805, Germany
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Klinikum Klagenfurt am Wörthersee, Institut für Diagnostische und Interventionelle Radiologie
Klagenfurt, 9020, Austria
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Klinikverbund Allgäu gGmbH, Herz- und Gefäßzentrum Oberallgäu Kempten, Klinik Immenstadt
Immenstadt im Allgäu, 87509, Germany
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Kreiskrankenhaus Torgau, Abt. Innere Medizin / Angiologie
Torgau, 04860, Germany
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Marienhaus Klinikum Mainz, Klinik für Diagnostische und Interventionelle Radiologie
Mainz, 55131, Germany
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Medical University Vienna, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie
Vienna, State of Vienna, A-1090, Austria
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Medizinische Universität Graz, Klinische Abteilung für Angiologie
Graz, 8010, Austria
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Sana Kliniken Oberfranken Coburg
Coburg, 96450, Germany
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Schön Klinik Rendsburg, Institut für Diagnostische und Interventionelle Radiologie/Neuroradiologie
Rendsburg, 24768, Germany
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St. Franziskus-Hospital GmbH, Klinik für Gefäßchirurgie
Münster, 48145, Germany
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University Heart Center Freiburg-Bad Krozingen
Bad Krozingen, 79189, Germany
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University Hospital Jena
Jena, 07747, Germany
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Universitätsklinik für Radiologie und Nuklearmedizin, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie
Vienna, 1090, Austria
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Universitätsklinikum Dresden, Institut und Poliklinik für Diagnostische und Interventionelle Radiologie
Dresden, 01307, Germany
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Universitätsklinikum Essen, Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie
Essen, 45147, Germany
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Universitätsklinikum Heidelberg, Medizinische Klinik III, Kardiologie, Angiologie und Pneumologie
Heidelberg, 69120, Germany
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Universitätsklinikum Leipzig, Klinik und Poliklinik für Angiologie
Leipzig, 04103, Germany
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Universitätsklinikum Münster, Klinik für Kardiologie I, Koronare Herzkrankheit, Herzinsuffizienz und Angiologie
Münster, 48149, Germany