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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.
Official title: A Prospective PMCF Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of Symptomatic Peripheral Arterial Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
284
Start Date
2025-05-22
Completion Date
2029-04
Last Updated
2026-03-11
Healthy Volunteers
No
Interventions
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
Locations (13)
AZORG
Aalst, Belgium
AZ Sint-Blasius
Dendermonde, Belgium
ZOL Genk
Genk, Belgium
AZ Groennge
Kortrijk, Belgium
RZ Heilig Hart Tienen
Tienen, Belgium
AZ Jan Portaels
Vilvoorde, Belgium
Klinikum Lippe Detmold
Detmold, Germany
SRH Klinikum Karlsbad-Langensteinbach GmbH
Karlsbad, Germany
Singapore General Hospital
Singapore, Singapore
Hospital Universitario de Cabueñes
Gijón, Spain
Hospital General de Granollers
Granollers, Spain
Complejo Hospitalario Universitario de Ourense
Ourense, Spain
Hospital Universitario de Toledo
Toledo, Spain