Single-arm, open-label, multi-center subject Registry of the R-OneTM system to evaluate its real-world performance and safety during PCI, from the start of the procedure and until hospital discharge. Post-Market Clinical Follow-up study
Sponsors
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 cardiac events (MACE).
- Technical success: absence of any unplanned manual assistance or conversion to manual PCI for procedural completion
CERC Services
- Clinical trial documentation
- Project management
- Monitoring activities
- Safety reporting
- Clinical report
- Statistical Analysis
Countries
4 countries:
Europe: Germany, France, Poland, Belgium.
Number of investigational sites
up to 15
