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RECRUITING
NCT05505929

eUltra 10k - Biofreedom Ultra

Sponsor: Biosensors Europe SA

View on ClinicalTrials.gov

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.

Official title: A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

10000

Start Date

2023-06-15

Completion Date

2029-03-30

Last Updated

2026-03-04

Healthy Volunteers

No

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.

Locations (10)

Krankenhaus Barmherzige Brüder

Eisenstadt, Austria

Clinique Des Domes Psr

Clermont-Ferrand, France

Klinikum Lippe

Detmold, Germany

Hospital Marques Valdecilla

Santander, Spain

University and Hospital Fribourg

Fribourg, Switzerland

Universitäres Herzzentrum

Zurich, Switzerland

Military hospital

Tunis, Tunisia

Al Qassimi Hospital

Sharjah city, United Arab Emirates

Royal Bournemouth hospital

Bournemouth, United Kingdom

Golden Jubilee National Hospital

Glasgow, United Kingdom