Balloon battle: which device keeps leg arteries open longer?

NCT ID NCT03884257

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.

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