NCT06832631

VITUS Post-Market Registry

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 284 (estimated)
• Sponsor: OrbusNeich · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The multicenter, prospective registry population consists of consecutive patients with peripheral arterial occlusive disease (PAOD) who undergo percutaneous transluminal angioplasty (PTA) intervention and are intended to be or treated by the VITUS peripheral drug-coated dilatation catheter (according to the Instructions for Use) as part of routine clinical care. Approximately 284 patients from approximately 15 centers in Europe will be entered into the registry. Patients entered into the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up. A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, and 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.

Conditions

• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-22
• Primary completion: 2027-04-01
• Completion: 2029-04-01
• First posted: 2025-02-18
• Last updated: 2026-03-11

Locations

13 sites across 4 countries: Belgium, Germany, Singapore, Spain