Balloon battle: which device keeps leg arteries open longer?

NCT ID NCT03884257

Ongoing Disease control Sponsor: KANDO Research Source: ClinicalTrials.gov ↗

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

Summary

This study tests whether a new drug-coated balloon (Passeo-18 Lux) is as safe and effective as an existing one (IN.PACT Admiral) for opening blocked leg arteries in people with peripheral artery disease. About 302 participants with moderate to severe symptoms are randomly assigned to receive one of the two balloons during a minimally invasive procedure. The balloons deliver a drug to help keep the artery from narrowing again, and patients are followed for 12 months to check for repeat blockages or complications.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

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

PERIPHERAL ARTERIAL DISEASE

Contacts and locations

Locations

A.Z. Sint-Blasius

Dendermonde, 9200, Belgium
CHU Bordeaux

Bordeaux, New Aquitaine, 33300, France
Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, CH-1011, Switzerland
Clinique Pasteur

Toulouse, Occitanie, 3100, France
Clinique Rhône Durance

Avignon, Provence-Alpes-Côte d'Azur Region, 84000, France
Hanusch Hospital

Vienna, State of Vienna, 1140, Austria
Hopital Paris Saint Joseph

Paris, 75014, France
Imelda Hospital

Bonheiden, 2820, Belgium
Medical University of Graz

Graz, Graz, 8036, Austria
OLV Ziekenhuis Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium
R.Z. Heilig Hart

Tienen, 3300, Belgium
Triemlispital Zürich

Zurich, Canton of Zurich, 8063, Switzerland
UZA

Antwerp, Antwerp, 2650, Belgium
Z.O.L.

Genk, 3600, Belgium

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