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

NCT04138238 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2023-07-12

No results posted yet for this study

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

Interventions

DEVICE

Supraflex Cruz Sirolimus-eluting Stent

Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care

Sponsors & Collaborators

  • European Cardiovascular Research Center

    collaborator NETWORK

  • Sahajanand Medical Technologies Limited

    lead INDUSTRY

Principal Investigators

  • Prof. Christoph K Naber, PD. Dr. Med. · Klinikum Wilhelmshaven

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-19
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • France
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04138238 on ClinicalTrials.gov