Informations générales (source: ClinicalTrials.gov)
A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
Observational [Patient Registry]
Biosensors Europe SA (Voir sur ClinicalTrials)
juin 2023
mars 2029
26 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Matthieu PERIER | 05/05/2025 07:12:12 | Contacter | ||
Critères
Tous
Inclusion Criteria:
- According to the current version of Instructions of Use (IFU)
- Patient is at least 18 years old
- Patient provides a signed informed consent
- According to the current version of Instructions of Use (IFU)
- Patient is at least 18 years old
- Patient provides a signed informed consent
- 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