Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
ANCRAGE: Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
Acandis GmbH
100 participants
Dec 1, 2021
OBSERVATIONAL
Conditions
Summary
The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and performance of Acandis Device(s) after its placing on the French market. On top of this, these cohorts will generate data for getting the renewal of the device's reimbursement on the French market.
Eligibility
Inclusion Criteria3
- The subject has an intracranial aneurysm that can be treated with one of the Acandis device indicated for the treatment of intracranial aneurysms.
- The subject is 18 years of age or older.
- The subject is willing to comply with scheduled visits and examinations, per institution standard of care.
Exclusion Criteria2
- The subject has provided tacit opposition to data collection.
- Any IFU warning will be considered for exclusion in the cohort.
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06940934