Status:

RECRUITING

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

Lead Sponsor:

Acandis GmbH

Conditions:

Intracranial Aneurysms

Eligibility:

All Genders

18+ years

Brief 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 ...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

December 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06940934

Start Date

December 1 2021

End Date

April 1 2027

Last Update

April 23 2025

Active Locations (1)

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Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle)

Rouen, France, 76000