Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE

Recruiting now

Conditions studied: Intracranial Aneurysms

In brief

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.

Key facts

Study ID

NCT06940934

Run by

Acandis GmbH

People needed

100

Starts

2021-12-01

Expected to finish

2027-04-01

Last updated by the study team

2025-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• The subject has provided tacit opposition to data collection.
• Any IFU warning will be considered for exclusion in the cohort.

Where it is running

• Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle) — Rouen, France (enrolling)

Full record on ClinicalTrials.gov

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