Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02783339
Status:
COMPLETED
Last Update Posted:
2020-08-28
First Post:
2016-05-23
Brief Title:
Neuroform Atlas Stent for Intracranial Aneurysm Treatment
Sponsor:
Stryker Neurovascular
Organization:
Stryker Neurovascular
Study Overview
Official Title:
Evaluation of Safety and Performance of the Neuroform AtlasTM Stent System for Intracranial Aneurysm Treatment - Post Market Clinical Follow-up
Status:
COMPLETED
Status Verified Date:
2020-08
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 EU PMCF
Brief Summary:
The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment
Detailed Description:
The study is a prospective multicenter open-label single arm post market follow-up registry designed to demonstrate the potential treatment of intracranial saccular aneurysms with the Next Generation Neuroform Stent System The study will evaluate the permanent morbidity and mortality rate within the 12 to 16 months following the procedure The study will evaluate as well 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 to 16 months Subjects with documented saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling provided they meet the other eligibility criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None