eUltra 10k - Biofreedom Ultra
A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
Biosensors Europe SA
10,000 participants
Jun 15, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- According to the current version of Instructions of Use (IFU)
- Patient is at least 18 years old
- Patient provides a signed informed consent
Exclusion Criteria3
- 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
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05505929