Actively Recruiting
Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
Led by Acandis GmbH · Updated on 2025-04-23
100
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject has an intracranial aneurysm that can be treated with one of the Acandis devices indicated for intracranial aneurysm treatment.
- 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.
You will not qualify if you...
- The subject has provided tacit opposition to data collection.
- Any Instructions for Use (IFU) warning related to the device will lead to exclusion from the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle)
Rouen, France, 76000
Actively Recruiting
Research Team
A
Acandis GmbH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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