Status:
RECRUITING
eUltra 10k - Biofreedom Ultra
Lead Sponsor:
Biosensors Europe SA
Collaborating Sponsors:
European Cardiovascular Research Center
Conditions:
Post Market Clinical Follow up (PMCF)
Eligibility:
All Genders
18+ years
Brief 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 Surveill...
Detailed Description
Prospective, observational multi-center registry to be conducted at up to 150 interventional cardiology centers in up to 15 countries. Patients will be followed by telephone for 1 year after PCI for d...
Eligibility Criteria
Inclusion
- According to the current version of Instructions of Use (IFU)
- Patient is at least 18 years old
- Patient provides a signed informed consent
Exclusion
- According to current version of IFU
- Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: "Clinical investigations on minors" and article 66: "Clinical investigations on pregnant or breastfeeding women"
- Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision
Key Trial Info
Start Date :
June 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2029
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT05505929
Start Date
June 15 2023
End Date
March 30 2029
Last Update
March 4 2026
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Krankenhaus Barmherzige Brüder
Eisenstadt, Austria
2
Clinique Des Domes Psr
Clermont-Ferrand, France
3
Klinikum Lippe
Detmold, Germany
4
Hospital Marques Valdecilla
Santander, Spain