R-One Registry CHANGE
- 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.
Co- 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
- Study coordination
- Regulatory submissions
- Site contract management
- Data management
- SAE reporting
- Statistical analysis
France, Belgium, Germany, Poland, South Africa
Number of investigational sites: 15