RESTORE is a single arm, prospective, multicentre, pilot study to evaluate the safety and performance of AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population.
A total of 120 subjects will be recruited across France and India, with approximately 40 participants expected to be recruited at a single study site in France.
Sponsor
Primary endpoints
- Composite end point of MACE assessed at 9 months follow-up
CERC Services
- Clinical trial documentation
- Monitoring activities
- Project management
- Regulatory submissions
- Sites Contracts & Fees management
- TMF set-up and maintenance
Countries
France
Number of investigational sites
1 site in France
Number of patients
40 patients expected
