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

Acandis GmbH100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Intracranial Aneurysms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle)

Rouen, France

Outcomes

Primary Outcomes

Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation

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.

Time frame: 12+/-3 months after treatment