VITUS Post-Market Registry
NCT06832631 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 284
Last updated 2026-03-11
Summary
To collect post marketing surveillance data on consecutive patients with peripheral arterial occlusive disease (PAOD) intended to be or treated by the VITUS peripheral drug-coated dilatation catheter when used according to the Instructions for Use and treating physician decision. Data will be collected in order to assess the long-term safety and performance of the VITUS peripheral drug-coated dilatation catheter in routine clinical practice.
Conditions
- Peripheral Arterial Disease
- Peripheral Arterial Occlusive Disease
Interventions
- DEVICE
-
Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
Balloon angioplasty for the treatment of symptomatic peripheral arterial disease with a paclitaxel drug-coated balloon
Sponsors & Collaborators
-
Eucatech AG
collaborator INDUSTRY -
Centre Européen de Recherche Cardiovasculaire
collaborator UNKNOWN -
OrbusNeich
lead INDUSTRY
Principal Investigators
-
Koen Deloose, MD · AZ St Blasius Dendermonde
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-22
- Primary Completion
- 2027-04-30
- Completion
- 2029-04-30
Countries
- Belgium
- Germany
- Singapore
- Spain
Study Locations
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