Safety and Performance of the Neuroform Atlas™ Stent System (ATLAS-FR)

June 16, 2020 updated by: Stryker Neurovascular

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
permanent morbidity and mortality rate
Time Frame: up to 12-16 months post-procedure
any major ipsilateral stroke or neurological death
up to 12-16 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AEs and device malfunctions
Time Frame: peri-procedure
All intra-procedural AEs and device malfunctions
peri-procedure
Efficacy Endpoint with mRS
Time Frame: immediately post-procedure and at 12-16 months post procedure
Proportion of aneurysms with Raymond-Roy Occlusion Class I, II or III
immediately post-procedure and at 12-16 months post procedure
Retreatment
Time Frame: up to 12-16 months
Occurence of re-treatment
up to 12-16 months
Subarachnoid hemorrhage (SAH)
Time Frame: Up to 12-16 months
Occurence of SAH
Up to 12-16 months
Aneurysm rupture/re-rupture
Time Frame: Up to 12-16 months
Occurence of Aneurysm rupture/re-rupture
Up to 12-16 months
SAEs resulting in neurological death
Time Frame: Up to 12-16 months
Rate of SAEs resulting in neurological death
Up to 12-16 months
device-related SAEs
Time Frame: Up to 12-16 months
Occurence of device-related SAEs
Up to 12-16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Neurovascular

Investigators

  • Principal Investigator: Emmanuel Houdart, MD, Hopital Lariboisiere

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2019

Primary Completion (Anticipated)

May 15, 2021

Study Completion (Anticipated)

July 15, 2021

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T4062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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