Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411418
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-15
Brief Title:
Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
SHIELD
Brief Summary:
The Jacobs Institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the Pipeline Flex Embolization Device with Shield Technology for the endovascular treatment of adults 22 years of age or older with wide-necked intracranial aneurysms
Detailed Description:
The Pipeline Flex Embolization Device with Shield Technology for the endovascular treatment of adults 22 years of age or older with large or giant wide-necked intracranial aneurysms IAs in the internal carotid artery from the petrous to the superior hypophyseal segments The Pipeline Flex Embolization Device with Shield Technology is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults 22 years of age or older with small and medium wide-necked neck width 4 mm or dome-to-neck ratio 2 saccular or fusiform intracranial aneurysm IAs arising from a parent vessel with a diameter 20 mm and 50 mm
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