Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
NCT06940934 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2025-04-23
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.
Conditions
- Intracranial Aneurysms
Sponsors & Collaborators
-
Acandis GmbH
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-04-30
Countries
- France
Study Locations
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