Cruz HBR Registry is post-market, prospective, multi-center, open-label, single-arm registry to evaluate the safety and efficacy of the Supraflex Cruz™ sirolimus-eluting coronary stent system in the treatment of all-comer patients with coronary artery disease by Percutaneous Coronary Intervention, to confirm the results from TALENT trial. The secondary objective of this registry is to demonstrate that the Supraflex Cruz™ stent is not inferior to the BioFreedom™ stent in High Bleeding Risk patients.
Primary endpoints
Composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel and clinically driven target lesion revascularization at 1 year.
CERC Services
- Clinical trial documentation
- Regulatory submissions
- Set-up activities (sites selection, insurance management, contract management)
- CRF and Data management
- Monitoring activities
- Clinical Events Committee (CEC) activities
- CoreLab activities
- Clinical report
Countries
France, Germany, Switzerland
Number of investigational sites
26
Number of patients
1200
