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

  • STATUS
    Not Recruiting
  • End date
    Nov 21, 2021
  • participants needed
    1200
  • sponsor
    Sahajanand Medical Technologies Pvt. Ltd.
Updated on 25 January 2021
stenosis
sirolimus
angina pectoris
unstable angina
ischemia
stable angina

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.

Details
Condition Coronary Artery Disease, Coronary heart disease
Treatment Supraflex Cruz Sirolimus-eluting Stent
Clinical Study IdentifierNCT04138238
SponsorSahajanand Medical Technologies Pvt. Ltd.
Last Modified on25 January 2021

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