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RECRUITING
NCT06832631

VITUS Post-Market Registry

Sponsor: OrbusNeich

View on ClinicalTrials.gov

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

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

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