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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Devices of the DERIVO family | |||
| ACCLINO flex plus Stent |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Acandis GmbH | Contact | +49 7231 980 84 0 | clinicalaffairs@acandis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle) | Recruiting | Rouen | 76000 | France |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |