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Clinical Trials/NCT04162483
NCT04162483UnknownNot Applicable

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 enrollmentStarted: November 19, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
310
Locations
1
Primary Endpoint
permanent morbidity and mortality rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Stryker Neurovascular
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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