Post-Market Registry to Evaluate the Safety and Efficacy of the The SUPRAFLEX CRUZ™ Sirolimus Eluting Coronary Stent System in the Treatment of an Octo- and Nonagenerian All-Comer Patient Cohort With Coronary Artery Disease - the Cruz Senior Study

CompletedOBSERVATIONAL
Enrollment

2,017

Participants

Timeline

Start Date

June 23, 2021

Primary Completion Date

June 12, 2025

Study Completion Date

June 12, 2025

Conditions
Coronary Disease
Interventions
DEVICE

The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system

"Investigational device: SUPRAFLEX CRUZ™ Sirolimus eluting Coronary Stent System The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system consists of a balloon ex-pandable Sirolimus eluting stent, premounted on a stent delivery system. The active pharmaceutical ingredient in the SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent is Sirolimus (also known as Rapamycin).~The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic Ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions in native coronary arter-ies with a reference vessel diameter of 2.00 mm to 4.50 mm."

Trial Locations (1)

Unknown

Charité Berlin, Berlin

All Listed Sponsors
lead

IHF GmbH - Institut für Herzinfarktforschung

OTHER