Intracranial Aneurysm
Conditions
Brief summary
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.
Detailed description
This proposed ATLAS FR study will be a retrospective review conducted to expand our knowledge of the clinical outcomes in subjects treated in France between 01 February 2017 and 01 March 2018. This will provide a comprehensive data set that is specifically representative of the Atlas stent use in France.
Interventions
Stenting Assisted coiling procedure
Sponsors
Stryker Neurovascular
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient who had undergone a stent assisted intracranial aneurysm coiling with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 1st Feb 2017 and 1st March 2 018. * Patient and/or their representative have/has received the written information concerning the study and not expressed opposition to the collection of his data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| permanent morbidity and mortality rate | up to 12-16 months post-procedure | any major ipsilateral stroke or neurological death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoint with mRS | immediately post-procedure and at 12-16 months post procedure | Proportion of aneurysms with Raymond-Roy Occlusion Class I, II or III |
| Retreatment | up to 12-16 months | Occurence of re-treatment |
| Subarachnoid hemorrhage (SAH) | Up to 12-16 months | Occurence of SAH |
| AEs and device malfunctions | peri-procedure | All intra-procedural AEs and device malfunctions |
| SAEs resulting in neurological death | Up to 12-16 months | Rate of SAEs resulting in neurological death |
| device-related SAEs | Up to 12-16 months | Occurence of device-related SAEs |
| Aneurysm rupture/re-rupture | Up to 12-16 months | Occurence of Aneurysm rupture/re-rupture |
Countries
France
Contacts
Primary ContactCaroline Le Page, RN
Outcome results
None listed