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

Acandis

Status: Enrolling

Conditions: Intracranial Aneurysms

Study type: Observational

Funder types: Industry

Identifiers

NCT06940934

ANCRAGE PMS

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Devices of the DERIVO family

ACCLINO flex plus Stent