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

NCT06940934 | Recruiting

• 1 other identifier: ANCRAGE PMS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (1)

• 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.

  12+/-3 months after treatment

Study Arms (2)

Devices of the DERIVO family

ACCLINO flex plus Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Each cohort will consist of subjects with an intracranial aneurysm whom the physician wishes to treat with one or more Acandis devices. Each subject will be followed according to the standard of care within the participating sites. All treated (and intended to treat with at least 1 Acandis device inserted) cases will be captured in the ANCRAGE study database, from the date of agreement with French authorities; that means it will be a consecutive prospective enrollment to demonstrate the exhaustivity at the site, even the cases are captured in the database retrospectively. There is a minimum of 50 consecutive cases to be enrolled per device family, from the time the device has been put on the French market and until the needed report to the authorities (for instance the renewal of the device registration/reimbursement).

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.

Sponsors & Collaborators

• Acandis GmbH: lead

Study Sites (1)

Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle)

Rouen, 76000, France

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Acandis GmbH

CONTACT

+49 7231 980 84 0; clinicalaffairs@acandis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

FR (1)