Ignite Creation Date:
2024-05-06 @ 1:43 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04106583
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2019-09-25
Brief Title:
Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
Sponsor:
Penumbra Inc
Organization:
Penumbra Inc
Study Overview
Official Title:
A Prospective Multicenter Study Assessing the Embolization of Intracranial Aneurysms Using WAVE Extra Soft Coils a Part of the Penumbra SMART COIL System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
SURF
Brief Summary:
The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL System including the WAVE Extra Soft Coils WAVE as a fill and finish coil in the treatment of intracranial aneurysms Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None