Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04057352
Status:
RECRUITING
Last Update Posted:
2023-10-02
First Post:
2019-08-01
Brief Title:
Citadel Embolization Device Study
Sponsor:
Stryker Neurovascular
Organization:
Stryker Neurovascular
Study Overview
Official Title:
The Citadel Embolization Device Study
Status:
RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
The purpose of this study is to gather safety and effectiveness data on Stryker Neurovasculars Next Generation Target Detachable Coil hereafter referred to as the Citadel Embolization Device when used with Target Detachable Coils in the treatment of wide-neck intracranial aneurysms
Detailed Description:
In this study use of the Citadel Embolization Device will be limited to a population of patients with unruptured or ruptured wide-neck aneurysms who meet all study eligibility criteria The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None