Safety and Performance of the Neuroform Atlas™ Stent System in Patients Requiring Stent Assisted Intracranial Aneurysm Treatment in France - A National, Retrospective Multi-center Registry

Stryker Neurovascular1 site in 1 country310 target enrollmentNovember 19, 2019

ConditionsIntracranial Aneurysm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intracranial Aneurysm
Sponsor: Stryker Neurovascular
Enrollment: 310
Locations: 1
Primary Endpoint: permanent morbidity and mortality rate
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 19, 2019

End Date

July 15, 2021

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Stryker Neurovascular

Responsible Party

Sponsor

Eligibility Criteria

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
•Patient and/or their representative have/has received the written information concerning the study and not expressed opposition to the collection of his data

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

permanent morbidity and mortality rate

Time Frame: up to 12-16 months post-procedure

any major ipsilateral stroke or neurological death

Secondary Outcomes

Retreatment(up to 12-16 months)
AEs and device malfunctions(peri-procedure)
Subarachnoid hemorrhage (SAH)(Up to 12-16 months)
Aneurysm rupture/re-rupture(Up to 12-16 months)
SAEs resulting in neurological death(Up to 12-16 months)
Efficacy Endpoint with mRS(immediately post-procedure and at 12-16 months post procedure)
device-related SAEs(Up to 12-16 months)