A Prospective PMCF Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of Symptomatic Peripheral Arterial Disease

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Consecutive patients intended to be or treated by the VITUS peripheral drug-coated dilatation catheter as per physicians' decision and according to IFU in the setting of routine clinical care are entered into the registry

• The lesion to be treated should be shorter than the nominal length of balloon at a reference vessel diameter of 2.0 mm up to 7.0 mm.

⁃ If lesion is longer than the individual balloon, more than one DCB can be used for longer lesions with the mandatory overlapping balloons of 10mm to avoid any geographical miss.

• Rutherford clinical categories 2-5

Locations
Other Locations
Belgium
AZORG
RECRUITING
Aalst
AZ Sint-Blasius
RECRUITING
Dendermonde
RZ Heilig Hart Tienen
RECRUITING
Tienen
AZ Jan Portaels
RECRUITING
Vilvoorde
Germany
Klinikum Lippe Detmold
RECRUITING
Detmold
SRH Klinikum Karlsbad-Langensteinbach GmbH
RECRUITING
Karlsbad
Spain
Hospital General de Granollers
RECRUITING
Granollers
Complejo Hospitalario Universitario de Ourense
RECRUITING
Ourense
Hospital Universitario de Toledo
RECRUITING
Toledo
Contact Information
Primary
Jenny Chong, BS
jchong@orbusneich.com
+6012 298-0651
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2029-04
Participants
Target number of participants: 284
Treatments
VITUS peripheral drug-coated dilatation catheter
The VITUS peripheral drug-coated dilatation catheter is indicated for use in patients with peripheral arterial occlusive disease (PAOD).
Sponsors
Collaborators: Centre Européen de Recherche Cardiovasculaire, Eucatech AG
Leads: OrbusNeich

This content was sourced from clinicaltrials.gov

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