Ignite Creation Date:
2024-05-06 @ 3:42 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02340585
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2015-01-13
Brief Title:
Neuroform Atlas Stent System Study
Sponsor:
Stryker Neurovascular
Organization:
Stryker Neurovascular
Study Overview
Official Title:
Safety and Effectiveness of the Treatment of Wide Neck Intracranial Saccular Aneurysms With the Next Generation Neuroform Stent System
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATLAS
Brief Summary:
The primary objective of this study is to demonstrate effectiveness and safety of the Neuroform Atlas Stent System for use with bare metal embolic coils
Detailed Description:
The study is a prospective multicenter open-label single arm trial designed to demonstrate the potential treatment of wide neck intracranial saccular aneurysms with the Next Generation Neuroform Stent System with any approved embolic coils currently on the market The study will evaluate the percent occlusion of the treated target lesion on angiography in the absence of retreatment or parent artery stenosis at the target location at 12 months Subjects with documented wide neck intracranial saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling provided they meet the other eligibility criteria
Data collected through the 12-month follow-up visit are intended to support Premarket Approval PMA application to the Food and Drug Administration FDA Long-term follow-up data collected through 3 years postoperative are intended to support post-approval study PAS requirements
Data collected through the 12-month follow-up visit are intended to support Premarket Approval PMA application to the Food and Drug Administration FDA Long-term follow-up data collected through 3 years postoperative are intended to support post-approval study PAS requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None