New balloon could keep leg arteries open longer

NCT ID NCT04971772

Ongoing Disease control Sponsor: Cardionovum GmbH Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a paclitaxel-coated balloon (Legflow DCB) to a standard uncoated balloon for treating blocked leg arteries in people with peripheral artery disease. About 150 participants with moderate to severe symptoms will be randomly assigned to one of the two treatments. The goal is to see if the drug-coated balloon reduces the need for repeat procedures and improves safety.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: paclitaxel-coated balloon (Legflow DCB)
What this could lead to: If it works, this could provide a better treatment option for people with blocked leg arteries, reducing the need for repeat procedures.
What could go wrong: This is a mid-stage trial with 150 participants. The drug-coated balloon may not prove safer or more effective than the standard balloon, and there are potential risks like vessel damage or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease peripheral vascular disease

As listed by the trial registrant

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

ANGIOPATHY, PERIPHERAL PERIPHERAL ARTERIAL DISEASE SUPERFICIAL FEMORAL ARTERY STENOSIS

Contacts and locations

Locations

Coris Medicina Vascular

Florianópolis, 88020-210, Brazil
GRN-Klinik Weinheim

Weinheim, 69120, Germany
Hospital Universitario da Universidade Federal de Santa Cataria

Florianópolis, 88040-900, Brazil
Hôpital de la Providence

Neuchâtel, 2000, Switzerland
Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland
Kreiskrankenhaus Alsfeld

Alsfeld, 36304, Germany
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

Hamburg, 69469, Germany
SRH Klinikum Karlsbad-Langenseinbach GmbH

Karlsruhe, 76307, Germany
Sankt Gertrauden-Krankenhaus Berlin

Berlin, State of Berlin, 10713, Germany
St. Franziskus-Hospital GmbH

Münster, 48145, Germany
Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

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