Safety and Performance of the Neuroform Atlas™ Stent System

Intracranial Aneurysm Clinical Trial

— ATLAS-FR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162483
• Other study ID #: T4062
• Status: Recruiting
• Start date: November 19, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: June 2020
• Source: Stryker Neurovascular
• Contact: Caroline Le Page, RN
• Phone: +33678777761
• Email: Caroline.lepage[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: July 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Neuroform Atlas Stent System
Stenting Assisted coiling procedure

Locations

Country	Name	City	State
France	CHU Gui de Chauliac	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	permanent morbidity and mortality rate	any major ipsilateral stroke or neurological death	up to 12-16 months post-procedure
Secondary	AEs and device malfunctions	All intra-procedural AEs and device malfunctions	peri-procedure
Secondary	Efficacy Endpoint with mRS	Proportion of aneurysms with Raymond-Roy Occlusion Class I, II or III	immediately post-procedure and at 12-16 months post procedure
Secondary	Retreatment	Occurence of re-treatment	up to 12-16 months
Secondary	Subarachnoid hemorrhage (SAH)	Occurence of SAH	Up to 12-16 months
Secondary	Aneurysm rupture/re-rupture	Occurence of Aneurysm rupture/re-rupture	Up to 12-16 months
Secondary	SAEs resulting in neurological death	Rate of SAEs resulting in neurological death	Up to 12-16 months
Secondary	device-related SAEs	Occurence of device-related SAEs	Up to 12-16 months