R-One Registry CHANGE

Sponsor Name


Brief summary

  • 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

CERC Services

  • Study coordination
  • Regulatory submissions
  • Site contract management
  • Data management
  • SAE reporting
  • Statistical analysis



France, Belgium, Germany, Poland, South Africa 

Number of investigational sites: 15