INPERIA ADVANCE CARBOSTENT™ FOR INFRA-POPLITEAL ARTERY STENOSIS. . Evaluation of Safety and Performance in Everyday Clinical Practice
Objectif(s) de la recherche et intérêt pour la santé publique
Objectifs poursuivis
Domaines médicaux investigués
Bénéfices attendus
To systematically collect retrospective clinical data on the implantable medical device Inperia Advance in an unselected population treated within the intended use in the current clinical practice. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of Inperia Advance
Données utilisées
Catégories de données utilisées
Source de données utilisées
Variables sensibles utilisées
Calendrier du projet
Base légale pour accéder aux données
Durée de conservation aux fins du projet (en années)
15
Fondement juridique
Article 6 du RGPD (Licéité du traitement)
Article 9 du RGPD (Exception permettant de traiter des données de santé)
Transfert de données personnelles vers un pays hors UE
Droits des personnes
The retrospective observational study will comply with the General Data Protection Regulation (GDPR) and is under medical direction. All staff members underlie medical confidentiality. All personal and patient data are treated as confidential and will be stored only anonymized. The study will be registered in a publicly accessible database and the results will be made publicly available.. . The Sponsor and the principal Investigators are committed to the publication and widespread dissemination of the results of the observational study, if applicable; they will lead the process for final scientific documents preparation to be published or presented. The number of Authors will be determined according to the rules of the addressed scientific journal.. . All data and information collected during this study will be considered confidential by the Sponsor. All data used in the analysis and summary of this study will be anonymous, and without reference to specific study patient names. Access to study patient files will be limited to authorized personnel of the Sponsor, the Investigator and research staff. Authorized regulatory personnel have the right to inspect and copy all records pertinent to this study.