New balloon could save legs from amputation in PAD patients
NCT ID NCT04772300
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a special balloon coated with sirolimus (a drug that prevents re-blockage) to a standard balloon for opening blocked arteries below the knee in people with peripheral artery disease. About 230 participants will be randomly assigned to one of the two treatments. The goal is to see if the drug-coated balloon keeps arteries open longer and reduces the need for repeat procedures or amputation.
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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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AKH Wien, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie
Vienna, 1090, Austria
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Bonifatius-Hospital Lingen (Ems)
Lingen, 49808, Germany
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DIAKO 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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GRN Klinik Weinheim, Kardiologie/Angiologie
Weinheim, 69469, Germany
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Hanusch-Krankenhaus
Vienna, 1140, Austria
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Heart and Diabetes Center North Rhine Westphalia, Clinic for General and Interventional Cardiology/Angiology
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
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Krankenhaus Barmherzige Brüder Regensburg, Institut für Radiologie, Neuroradiologie und Nuklearmedizin
Regensburg, 93049, Germany
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Kreiskrankenhaus Torgau
Torgau, 04860, Germany
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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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University Hospital Leipzig
Leipzig, 04103, Germany
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University Hospital Tuebingen, Diagnostic and Interventional Radiology
Tübingen, Baden-Wurttemberg, 72076, Germany
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Universitäts-Herzzentrum Freiburg-Bad Krozingen; Clinic for Cardiology and Angiology II
Bad Krozingen, 79189, Germany
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Universitätsklinikum Brandenburg, Abteilung für Innere Medizin 1, Hochschulklinik für Angiologie
Brandenburg, 14770, Germany
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Universitätsklinikum Hamburg-Eppendorf, Universitäres Herz- und Gefäßzentrum Hamburg, Klinik und Poliklinik für Gefäßmedizin
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
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Universitätsklinikum Heidelberg, Medizinische Klinik III, Kardiologie, Angiologie und Pneumologie
Heidelberg, 69120, Germany
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Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie
Jena, 07747, Germany
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Universitätsklinikum Münster, Klinik für Kardiologie I, Koronare Herzkrankheit, Herzinsuffizienz und Angiologie
Münster, 48149, Germany
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