GORE Embolic Protection With Reverse Flow (EMPiRE)
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.
Carotid Artery Stenosis
Device: GORE Flow Reversal System (GFRS)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Composite Major Adverse Event (MAE) Rate [ Time Frame: Treatment through 30-day visit window ] [ Designated as safety issue: Yes ]Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee)
- Flow Reversal System Technical Success [ Time Frame: Procedure ] [ Designated as safety issue: Yes ]Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure)
- Flow Reversal System Success [ Time Frame: Procedure ] [ Designated as safety issue: Yes ]Number of participants where the GORE Flow Reversal System was delivered, placed, reverse flow was established, and the balloon sheath and wire retrieved as outlined in the Instructions for Use without causing any adverse events during the procedure.
- Stent Success [ Time Frame: Procedure ] [ Designated as safety issue: No ]Number of participants where the FDA-approved stent was successfully delivered, deployed,and delivery system removed with an attainment of < 50% residual stenosis following stent placement, as assessed by the angiographic core laboratory.
- Clinical Success [ Time Frame: 24-48 Hours Post-Procedure ] [ Designated as safety issue: Yes ]Number of participants with Flow Reversal System and Stent Success in the absence of death, emergency endarterectomy, repeat percutaneous transluminal angioplasty (PTA)/thrombolysis of the target vessel, stroke, or myocardial infarction (MI), as determined by the Clinical Events Committee (CEC).
- Patency at 30 Days [ Time Frame: Treatment through 30-day visit window ] [ Designated as safety issue: No ]Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.
|Study Start Date:||July 2006|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Experimental: GFRS Pivotal Subjects
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
Device: GORE Flow Reversal System (GFRS)
Carotid artery angioplasty and stenting with embolic protection
Other Name: Gore Neuro Protection System
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.
|United States, New York|
|Millard Fillmore Gates/Univ. of Buffalo|
|Buffalo, New York, United States, 14209|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Daniel Clair, M.D.||The Cleveland Clinic|
|Principal Investigator:||L. N. Hopkins, M.D.||Millard Fillmore Gates/Univ. of Buffalo|