Safety and Performance of the Neuroform Atlas™ Stent System | NCT04162483

Studies
Safety and Performance of the Neuroform Atlas™ Stent System

NCT04162483

Sponsor

Stryker Neurovascular

Status

Unknown status

Last Update Posted

Jun 17, 2020Actual

Enrollment

310Estimated

Phase

Not provided

Conditions

Intracranial Aneurysm

Interventions

Neuroform Atlas Stent System

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2019Actual

Primary Completion Date

May 15, 2021Estimated

Completion Date

Jul 15, 2021Estimated

First Submitted Date

Nov 11, 2019

First Submission Date that Met QC Criteria

Nov 11, 2019

First Posted Date

Nov 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2020

Last Update Posted Date

Jun 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

310Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuroform Atlas Stent System	Device	Stenting Assisted coiling procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
AEs and device malfunctions	All intra-procedural AEs and device malfunctions	peri-procedure
Efficacy Endpoint with mRS	Proportion of aneurysms with Raymond-Roy Occlusion Class I, II or III

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Caroline Le Page, RN	Contact	+33678777761		Caroline.lepage@stryker.com

Overall Officials

Name	Affiliation	Role
Emmanuel Houdart, MD	Hopital Lariboisière	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Gui de Chauliac	Recruiting	Montpellier		F-34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002532	Intracranial Aneurysm

Ancestor Terms

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided