The R-OneTM robotic platform is currently indicated for remote delivery and manipulation of coronary guidewires and stent/balloon devices during percutaneous coronary interventions. Robocath is seeking to expand the indication for use to include the common carotid artery, commonly classified as part of the peripheral vasculature. The objective of the study is to assess the feasibility of the R-One TM device in carotid artery stenting.
ID: NCT05093127
Sponsor
Primary endpoints
Procedure technical success, absence of any unplanned manual assistance or conversion to manual CAS for procedural completion
- Study coordination
- Regulatory submissions
- Site contract management
- EDC management
- Data management
- Statistical analysis
CERC Services
- Project management
- Regulatory submissions
- Sites' contract management
- EDC and data management
- Statistical Analysis
Countries
France
Number of investigational sites
1
Number of patients
7
