CRUZ HBR REGISTRY

Brief summary:

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,

Submission,

Set-up activities,

eCRF / data-management,

Monitoring,

CEC,

CoreLab activities,

Clinical report

Countries:

France, Germany, Switzerland

 

Center number:

25 investigational centers