NCT06678490

Support C Post-Market Registry

PMCF Registry Study Paclitaxel-eluting Balloon Catheter Support C

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 282 (actual)
• Sponsor: OrbusNeich · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Support C Drug Coated Balloon (DCB) in routine clinical practice.

Detailed description

This multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (PCI) and are intended to be or treated by the Support C Drug Coated Balloon (DCB) according to the Instructions for Use as part of routine clinical care. Approximately 278 patients from 8-12 centers in Europe will be entered into the registry. Patients in 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, 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.

Conditions

• Coronary Arteriosclerosis

Timeline

• Start date: 2025-07-09
• Primary completion: 2027-02-01
• Completion: 2029-02-01
• First posted: 2024-11-07
• Last updated: 2026-02-10

Locations

12 sites across 4 countries: Czechia, Germany, Malaysia, Spain