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eUltra 10k - Biofreedom Ultra

NCT05505929 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2026-03-04

No results posted yet for this study

Summary

This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.

Conditions

  • Post Market Clinical Follow up (PMCF)

Interventions

DEVICE

Biofreedom Ultra

The BioFreedomTM Ultra CoCr DCS is a combination product consisting of two key components: the cobalt chromium stent platform coated abluminally with the active ingredient BA9TM (polymer and carrier free) and the delivery system.

Sponsors & Collaborators

  • European Cardiovascular Research Center

    collaborator NETWORK

  • Biosensors Europe SA

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2028-12-31
Completion
2029-03-30

Countries

  • Austria
  • France
  • Germany
  • Spain
  • Switzerland
  • Tunisia
  • United Arab Emirates
  • United Kingdom

Study Locations

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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 NCT05505929 on ClinicalTrials.gov