NCT06940934 Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
| NCT ID | NCT06940934 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Acandis GmbH |
| Condition | Intracranial Aneurysms |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-12-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06940934 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Aneurysms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06940934 currently recruiting?
Yes, NCT06940934 is actively recruiting participants. Contact the research team at clinicalaffairs@acandis.com for enrollment information.
Where is the NCT06940934 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT06940934 clinical trial?
NCT06940934 is sponsored by Acandis GmbH. The trial plans to enroll 100 participants.