Objective
The primary objective of the Cruz HBR registry is to confirm the safety and efficacy of the Supraflex Cruz DES in real life all-comer patients similar to Supraflex arm as demonstrated in the TALENT trial in an all-comers population. The secondary objective of this registry is to demonstrate non-inferiority compared to the BioFreedom™ stent in High Bleeding Risk patients.
Study Design
Prospective, multi-center, open-label, single-arm registry
All-comer patients affected by silent ischemia, stable angina or acute coronary syndrome (STEMI excluded), eligible for PCI
Follow-up at 6 months and 1 year
Composite of cardiovascular death, MI not clearly attributable to a non-target vessel and clinically driven TLR at 1 year
26 sites
3 countries: France, Germany, Switzerland
1203 patients
Supraflex Cruz Sirolimus Eluting Coronary Stent
Enrolled Patients
1203
737
466
Study Management Team
Prof. Christoph NABER
Principal Investigator
Dr Barbara STÄHLI
Coordinating PI Switzerland
Dr René KONING
Coordinating PI France
Prof. Lorenz RÄBER
CEC Chairperson
Dr Nikolaus LÖFFELHARDT
CEC Member
Dr Thierry ROYER
CEC Member
ARC HBR
using Academic Research Consortium HBR definitions
