R-evolution is a prospective, multicentre single arm clinical study. The purpose of the study is to assess the safety and efficacy of the robotic assistance R-ONETM in elective Percutaneous Coronary intervention.
This study has 2 primary endpoints:
- Safety Endpoint: For R-ONETM performed PCI, absence of intra-procedural complications, defined as coronary dissection ≥ NHLBI type D, perforation, decrease of TIMI flow (≤2), acute occlusion, visible thrombus formation, significant air embolus during the procedure, traumatic aortic or left main dissection by guiding catheter
- Efficacy Endpoint: procedure technical success, defined as successful advancement and retraction of all PCI devices (guidewires, balloon catheters and stents) and the successful treatment of all the target lesions using the R-ONETM system and without conversion to manual operation
Study tart-up activities, Clinical trial documentation, Project management, eCRF, Data management, Monitoring, CEC activities, Safety management, Statistical analysis, Final clinical report
France, Belgium, Luxembourg, The Netherlands
6 centers (3 in France, 1 in Belgium, 1 in Luxembourg and 1 in the Netherlands)