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eUltra 10k - Biofreedom Ultra

Name: eUltra 10k - Biofreedom Ultra — clinical trial record (NCT05505929)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhaseNot specified

SponsorBiosensors Europe SA

Started2023-06-15

View on ClinicalTrials.gov ↗

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.

Amendment record

Amended 2 times since 2022-08-16; most recent filed 2026-03-02. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-03-02

Amendment Study Status, Contacts/Locations v2

2023-08-22

Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

2022-08-16

Original filing

Trial Details

NCT Number	NCT05505929
Lead Sponsor	Biosensors Europe SA Collaborators: European Cardiovascular Research Center
Conditions	Post Market Clinical Follow up (PMCF)
Enrollment	10,000 participants
Start Date	2023-06-15
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-04