GORE Embolic Protection With Reverse Flow

Phase 3

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Carotid stenosis requiring revascularization and indicating either symptomatic status, with carotid stenosis ≥ 50% OR asymptomatic status with carotid stenosis ≥ 80%
Target lesion is located in one of the following:(a) internal carotid artery (ICA) (b) bifurcation (c) common carotid artery (CCA) proximal to the bifurcation
At Anatomic risk for adverse events from CEA (e.g. restenosis after a prior CEA) OR at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes)

Exclusion Criteria

Recent surgical procedure within 30 days before or after the stent procedure
Uncontrolled sensitivity to contrast media
Renal Insufficiency
Recent evolving, acute stroke within 21 days of study evaluation
Myocardial infarction within 72 hours prior to stent procedure
History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS)
Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS)

Angiographic Exclusion Criteria:

Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow
Total occlusion of the ipsilateral carotid artery
Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch
Presence of a filling defect, thrombus, occlusion or "string sign" in the target vessel
Severe lesion calcification restricting stent deployment
Carotid stenosis located distal to target stenosis that is more severe than target stenosis
> 50% stenosis of the CCA proximal to target vessel
Known mobile plaque in the aortic arch

Arm && Interventions

Group	Intervention	Description
GFRS Pivotal Subjects	GORE Flow Reversal System (GFRS)	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).

Primary Outcome Measures

Name	Time	Method
Composite Major Adverse Event (MAE) Rate	Treatment through 30-day visit window	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)

Secondary Outcome Measures

Name	Time	Method
Flow Reversal System Technical Success	Procedure	Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure)
Flow Reversal System Success	Procedure	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	Procedure	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	24-48 Hours Post-Procedure	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	Treatment through 30-day visit window	Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.

Locations (2): Millard Fillmore Gates/Univ. of Buffalo
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Buffalo, New York, United States
Cleveland Clinic Foundation
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Cleveland, Ohio, United States