NCT04138238

Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent

Post-market 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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (actual)
• Sponsor: Sahajanand Medical Technologies Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Supraflex Cruz Sirolimus-eluting Stent	Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care

Timeline

• Start date: 2020-02-19
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2019-10-24
• Last updated: 2023-07-12

Locations

26 sites across 3 countries: France, Germany, Switzerland