VITUS Post-Market Registry

NCT06832631 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 284

Last updated 2026-03-11

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06832631 on ClinicalTrials.gov