Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447116
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-03
Brief Title:
An EFS to Evaluate the CGuard Prime Carotid Stent in Acute Ischemic Stroke
Sponsor:
Jacobs institute
Organization:
Jacobs institute
Study Overview
Official Title:
An EFS to Evaluate the Safety and Preliminary Effectiveness of the CGuard Prime Carotid Stent Placement in the Procedure Setting of Acute Ischemic Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 Jacobs Institute is conducting a Sponsor Investigator study of patients 18 years to establish safety and preliminary effectiveness in treating extracranial stenosis with the CGuard Prime Carotid Stent in the setting as an acute ischemic stroke
Detailed Description:
A prospective single-arm open-label nonblinded EFS to assess the safety and preliminary effectiveness of the CGuard Prime Carotid Stent in adults 18 years of age or older with extracranial stenosis in the setting as an acute ischemic stroke
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