R-One registry (CHANGE) is a single-arm, open-label, multi-center subject registry in Europe and South Africa of the R-oneTM to examine its performance during PCI procedures at hospital discharge, whichever occurs first.
ID: NCT05853419
Sponsor
Primary endpoints
- Clinical success: Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the R-One System, without in-hospital major adverse coronary events (MACE).
- Technical success: absence of any unplanned manual assistance or conversion to manual PCI for procedural completion
CERC Services
- Project management
- Regulatory submissions
- Sites' contract management
- CRF and Data management
- SAE Reporting
- Statistical Analysis
Countries
France, Belgium, Germany, Poland, South Africa
Number of investigational sites
15
Number of patients
500
