Ignite Creation Date:
2024-05-05 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 9:41 AM
Study NCT ID:
NCT00594100
Status:
COMPLETED
Last Update Posted:
2013-12-27
First Post:
2007-12-20
Brief Title:
GORE Embolic Protection With Reverse Flow
Sponsor:
WLGore Associates
Organization:
WLGore Associates
Study Overview
Official Title:
The Embolic Protection With Reverse Flow Study of the GORE Neuro Protection System in Carotid Stenting of Subjects At High Risk for Carotid Endarterectomy
Status:
COMPLETED
Status Verified Date:
2013-12
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:
EMPiRE
Brief Summary:
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies
Detailed Description:
The GORE Flow Reversal System manufactured by W L Gore Associates Inc was developed as a proximal occlusion device to reverse the flow of blood in the carotid artery It is designed to achieve embolic protection prior to crossing the lesion in the majority of cases in order to minimize the possibility of an adverse event occurrence
The objective of this study is to assess the safety and effectiveness of the GORE Flow Reversal System when used to provide embolic protection during Carotid Artery Stent CAS procedures Subjects diagnosed with carotid stenosis requiring revascularization and are at high risk for adverse events from CEA are eligible to participate
The objective of this study is to assess the safety and effectiveness of the GORE Flow Reversal System when used to provide embolic protection during Carotid Artery Stent CAS procedures Subjects diagnosed with carotid stenosis requiring revascularization and are at high risk for adverse events from CEA are eligible to participate
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