An observational study in Intracranial Aneurysm, sponsored by Stryker Neurovascular. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2020-06-17.
Sponsored by Stryker Neurovascular · Observational
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.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's planned enrollment of 310 is above the median of 200 across 198 observational studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Stryker Neurovascular is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects treated in one of the French Sites participating to the registry and who have been treated with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 01 February 2017 and 01 March 2018.
Inclusion Criteria:
Stenting Assisted coiling procedure
permanent 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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stryker Neurovascular