Monitoring the safety and outcomes of Acandis devices for treating brain aneurysms in France
ANCRAGE: Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
Acandis GmbH · NCT06940934
This study is trying to see how safe and effective Acandis devices are for treating brain aneurysms in patients over a year after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Acandis GmbH (industry) |
| Locations | 1 site (Rouen) |
| Trial ID | NCT06940934 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect clinical data on patients treated for intracranial aneurysms using Acandis devices. It will assess mortality, morbidity, and neurological outcomes 12 months post-treatment, while also evaluating any residual risks associated with the devices. The data collected will support the long-term safety and performance evaluation of these devices and assist in the renewal of their reimbursement in France.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with an intracranial aneurysm that can be treated with Acandis devices.
Not a fit: Patients who have contraindications to the use of Acandis devices or who oppose data collection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the long-term safety and effectiveness of Acandis devices, potentially leading to improved treatment protocols for patients with intracranial aneurysms.
How similar studies have performed: While this study focuses on post-market surveillance, similar studies evaluating device safety and efficacy have shown success in providing valuable data for improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rouen
- Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle) — Rouen, France (RECRUITING)
Study contacts
- Study coordinator: Acandis GmbH
- Email: clinicalaffairs@acandis.com
- Phone: +49 7231 980 84 0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intracranial Aneurysms