This registry is studying the Advanta VXT and Flixene vascular graft safety and performance over a long period of time when used to replace or repair a blocked blood vessel in the body (for example, the leg). The purpose of this study is to see whether the medical device remains to be safe and effective over many years.
Objectif(s) de la recherche et intérêt pour la santé publique
Finalité de l'étude
Objectifs poursuivis
Domaines médicaux investigués
Bénéfices attendus
The overall objective is to evaluate the long-term safety and performance of Advanta VXT and Flixene vascular grafts for repair or replacement of peripheral arteries, including use of the vascular grafts in femoropopliteal and bifemoropopliteal bypass. These grafts have been commercially available since 1999 and therefore could provide up to 20+ years of long-term safety and performance data, if available.
This registry is also intended to provide further data on the clinical usefulness of the Advanta VXT and Flixene vascular grafts. Any complications related to the graft will be identified and reported in order to support post-market clinical follow-up.
An approximate 1,000 patients from up to 25 sites across the US and Europe will participate in this registry. The number of patients and sites included will ensure a representation of the overall population, specifically in vascular surgery. No mandated procedures, assessments or visits will be implemented, given the non-interventional nature of the registry. This registry does not specifically evaluate vulnerable patients, including pregnant patients, pediatric patients and/or prisoners. However, this registry may collect data related to an elderly population, which may represent a vulnerable patient population. Regardless, safeguards are in place given that there are no additional interventions that could put these patient populations at greater risk.
Données utilisées
Catégories de données utilisées
Source de données utilisées
Autre(s) source(s) de donnée(s) mobilisée(s)
Appariement entre les sources de données mobilisées
Variables sensibles utilisées
Justification du recours à cette(ces) variable(s) sensible(s)
The processing of personal data in this study will be carried out in accordance with the General Data Protection Regulation (GDPR). Specifically, the legal basis for processing in this case is Article 6(1)(e) GDPR, which permits processing necessary for the performance of a task carried out in the public interest. In the context of this registry study, the collection of long-term safety and performance data of the involved medical devices serves a recognized public interest, particularly in the area of public health and medical research.
In addition, as the study involves the processing of special categories of personal data (i.e., health data), Article 9(2)(j) GDPR applies, which allows processing necessary for scientific research purposes, subject to appropriate safeguards in accordance with Article 89(1) GDPR.
All data will be handled with strict adherence to data minimization and pseudonymization principles. Appropriate technical and organizational measures are in place to ensure compliance with data protection principles and to safeguard the rights and freedoms of the study participants.
Recours au numéro d'identification des professionnels de santé
Plateforme utilisée pour l'analyse des données
Acteurs finançant et participant à l'étude
Responsable(s) de traitement
Type de responsable de traitement 1
Responsable de traitement 1
Localisation du responsable de traitement 1
Représentant du responsable de traitement 1
Responsable(s) de mise en oeuvre non cités comme responsable de traitement
Responsable de mise en oeuvre non cité comme responsable de traitement 1
Responsable de mise en oeuvre non cité comme responsable de traitement 2
Calendrier du projet
Base légale pour accéder aux données
Encadrement réglementaire
Durée de conservation aux fins du projet (en années)
15
Existence d'une prise de décision automatisée
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
Pseudonymisation of data (a Subject ID will be applied when data is entered into the EDC and direct identifiers are retained only at the site. All data is pseudonymized before transferred to the Sponsor or CRO), data minimisation i.e. only “age at time of intervention” is collected, not the full date of birth, restricted access, secure transfer (as defined in the study protocol), data transfer outside the European Economic Area will be
done according to the European GDPR. Some countries outside Europe may not have laws which protect your privacy to the same extent as this European Data Protection Regulation. Controller will take all reasonable steps to protect your privacy. There will be Data Processing Agreements in place with vendors and sites to ensure compliance with GDPR requirements.
Droits des personnes
This retrospective registry is conducted using existing medical records from participants who have previously received Advanta VXT or Flixene vascular grafts or patches. In principle, data subjects have the rights described in GDPR Article 15 to 20 (access, rectification, erasure, restriction of processing, data portability, and objection), however, in accordance with Article 89(2) GDPR, in the context of this study, the exercise of these rights may be limited where their application would seriously impair the achievement of the scientific research objectives.
Furthermore, a declaration of conformity in line with MR-004 was submitted and acknowledged by the CNIL. Under this framework and pursuant to Article 14(5)(b) GDPR, no individual information leaflet or consent collection is required for retrospective research using existing medical records, as providing such information would involve disproportionate efforts. The legal basis for processing is the performance of a task carried out in the public interest and/or for scientific research purposes under Articles 6(1)(e) and 9(2)(j) GDPR.
Appropriate safeguards are implemented to protect the rights and freedoms of data subjects, including pseudonymization, data minimization, strict access controls, and secure data handling. In addition, registration with the Health Data Hub ensures further governance, traceability, and oversight of data processing.
Délégué à la protection des données
Kehler Strasse 31, Rastatt DERAS DE 76437 Germany DE 76437 Rastratt DERAS Allemagne
oliver.kientz@getinge.com