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.
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.
Study Type
OBSERVATIONAL
Enrollment
310
Stenting Assisted coiling procedure
CHU Gui de Chauliac
Montpellier, France
RECRUITINGpermanent morbidity and mortality rate
any major ipsilateral stroke or neurological death
Time frame: up to 12-16 months post-procedure
AEs and device malfunctions
All intra-procedural AEs and device malfunctions
Time frame: peri-procedure
Efficacy Endpoint with mRS
Proportion of aneurysms with Raymond-Roy Occlusion Class I, II or III
Time frame: immediately post-procedure and at 12-16 months post procedure
Retreatment
Occurence of re-treatment
Time frame: up to 12-16 months
Subarachnoid hemorrhage (SAH)
Occurence of SAH
Time frame: Up to 12-16 months
Aneurysm rupture/re-rupture
Occurence of Aneurysm rupture/re-rupture
Time frame: Up to 12-16 months
SAEs resulting in neurological death
Rate of SAEs resulting in neurological death
Time frame: Up to 12-16 months
device-related SAEs
Occurence of device-related SAEs
Time frame: Up to 12-16 months
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