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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle)

Rouen, 76000, France

Location status: Recruiting

Location contact

Chrysanthi Papagiannaki, Dr.

CONTACT

+33 2 32 88 89 90

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: 12+/-3 months after treatment

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Acandis GmbH

CONTACT

[email protected]

+49 7231 980 84 0

Sponsors and collaborators

Lead sponsor

Acandis GmbH

Industry

Registry information

Official study title

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

Acronym: ANCRAGE PMS

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2027
First posted: Apr 23, 2025
Registry last updated: Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting