An international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) clinical investigation to evaluate the clinical safety and effectiveness of the Coroflex® ISAR NEO stent for the treatment of coronary disease.
Sponsor
Study objectives
- Effectiveness of the device and of the procedure
- Safety of the device and of the procedure
- Clinical outcome at the end of the procedure and over 2 years of follow-up.
CERC Services
- Clinical trial documentation
- Contract management
- On-site monitoring
- Project management
- Regulatory submissions
Countries
Spain, France
Number of investigational sites
10 sites to be submitted in France
