Safety and Performance of the Neuroform Atlas™ Stent System

NCT ID: NCT04162483

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-19

Study Completion Date

2021-07-15

Brief Summary

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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

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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.

Conditions

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Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Neuroform Atlas Stent System

Stenting Assisted coiling procedure

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Neurovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel Houdart, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Lariboisière

Locations

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CHU Gui de Chauliac

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Caroline Le Page, RN

Role: CONTACT

+33678777761

Facility Contacts

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Vincent Costalat

Role: primary

Marinette Moynier

Role: backup

Other Identifiers

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T4062

Identifier Type: -

Identifier Source: org_study_id

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