eUltra 10k - Biofreedom Ultra
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiosensors Europe SA
About this trial
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 criteria
Qualifiers
According to the current version of Instructions of Use (IFU)
Patient is at least 18 years old
Patient provides a signed informed consent
Disqualifiers
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
Trial design
Treatments tested in this trial
- Biofreedom Ultra
Treatment groups
No treatment groups listed
Sponsors and collaborators
Biosensors Europe SA
Lead sponsor
European Cardiovascular Research Center
Collaborator
Source ClinicalTrials.gov