Actively Recruiting

Age: 18Years +
All Genders
NCT05505929

eUltra 10k - Biofreedom Ultra

Led by Biosensors Europe SA · Updated on 2026-03-04

10000

Participants Needed

10

Research Sites

302 weeks

Total Duration

On this page

Sponsors

B

Biosensors Europe SA

Lead Sponsor

E

European Cardiovascular Research Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

eUltra 10k - Biofreedom Ultra

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is at least 18 years old
  • Patient provides a signed informed consent
  • Meets the current version of Instructions for Use (IFU)
Not Eligible

You will not qualify if you...

  • Does not meet the current version of Instructions for Use (IFU)
  • Is a minor (underage) as defined by Medical Device Regulation (Article 65)
  • Is pregnant or breastfeeding as defined by Medical Device Regulation (Article 66)
  • Is under judicial protection, guardianship, curatorship, or deprived of liberty by judicial or administrative decision

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Krankenhaus Barmherzige Brüder

Eisenstadt, Austria

Actively Recruiting

2

Clinique Des Domes Psr

Clermont-Ferrand, France

Actively Recruiting

3

Klinikum Lippe

Detmold, Germany

Actively Recruiting

4

Hospital Marques Valdecilla

Santander, Spain

Actively Recruiting

5

University and Hospital Fribourg

Fribourg, Switzerland

Actively Recruiting

6

Universitäres Herzzentrum

Zurich, Switzerland

Actively Recruiting

7

Military hospital

Tunis, Tunisia

Actively Recruiting

8

Al Qassimi Hospital

Sharjah city, United Arab Emirates

Actively Recruiting

9

Royal Bournemouth hospital

Bournemouth, United Kingdom

Actively Recruiting

10

Golden Jubilee National Hospital

Glasgow, United Kingdom

Actively Recruiting

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Research Team

C

Calvin Bahr, MS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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