Clinical Trials in France / NCT06940934
Recruiting
Observational
Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
NCT06940934 · tracked via the Priya Life Science France tracker
Condition(s) studied
Intracranial Aneurysms
Study 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 Criteria:
* 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 Criteria:
* The subject has provided tacit opposition to data collection.
* Any IFU warning will be considered for exclusion in the cohort.
Primary outcome measure(s)
- Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation — 12+/-3 months after treatment
Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation, defined as a mRS \>/= 3 for the subjects with a baseline mRS between 0 and 2 or mRS increase of 1 point for subjects with a baseline mRS greater than 2.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle) | Rouen | France | Recruiting |
More Acandis GmbH trials in France
Other trials for the same condition
Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms
Active, not recruiting
Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN
Active, not recruiting
Risk Analysis of Intracranial Aneurysm Rupture Through Social Determinants of Health
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06940934 on ClinicalTrials.gov ↗ ← All trials in France