The Cruz Senior Study
Post-Market Registry to Evaluate the Safety and Efficacy of the SUPRAFLEX CRUZ Sirolimus eluting coronary stent system in the Treatment of an Octo- and Nonagenarian All-Comer Patient Cohort with Coronary Artery Disease
Objective of the Study:
- To evaluate the results of the SUPRAFLEX CRUZ Sirolimus-eluting coronary stent system in an aged (≥80 years) real-life patient cohort representing a significant most complex high-risk patient cohort for PCI in daily routine.
- To assess prospectively the clinical and patient–reported outcome (PROM) of PCI itself for different stages of CAD in a representative octo- and nonagenarian all-comer patient cohort.
- To prospectively evaluate new markers representing functional and frailty patients status to evaluate new concepts for risk stratification in PCI of aged CAD-patients.
Primary Endpoint:
- Device Oriented Composite Endpoint (DOCE as per ARC2) at 12 months defined as composite of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (TLR).
1993 Patients
Enrolled
Multicenter
43 sites in Germany, Switzerland, Austria, and France
12 months
Follow-up
Study Details | The Cruz Senior | https://clinicaltrials.gov/study/NCT04612179?term=cruz%20senior&rank=1
Coordinating Investigator:
Univ-Prof Dr. med David M. Leistner
Coordinating Sub-Investigator:
Dr. Imke J. Würdemann, MD