Safety and Performance of the Neuroform Atlas™ Stent System

• Conditions: Intracranial Aneurysm

• Registration Number: NCT04162483
• Lead Sponsor: Stryker Neurovascular

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.

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Study Start: 2019-11-19
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-17
• Primary Completion: 2021-05-15
• Study Completion: 2021-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
permanent morbidity and mortality rate	up to 12-16 months post-procedure	any major ipsilateral stroke or neurological death

Secondary Outcome Measures

Name	Time	Method
AEs and device malfunctions	peri-procedure	All intra-procedural AEs and device malfunctions
Subarachnoid hemorrhage (SAH)	Up to 12-16 months	Occurence of SAH
Aneurysm rupture/re-rupture	Up to 12-16 months	Occurence of Aneurysm rupture/re-rupture
device-related SAEs	Up to 12-16 months	Occurence of device-related SAEs
Retreatment	up to 12-16 months	Occurence of re-treatment
SAEs resulting in neurological death	Up to 12-16 months	Rate of SAEs resulting in neurological death
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

Trial Locations

Locations (1)

CHU Gui de Chauliac; 🇫🇷 Montpellier, France