GORE Embolic Protection With Reverse Flow

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Embolic Protection With Reverse Flow Study of the GORE Neuro Protection System in Carotid Stenting of Subjects At High Risk for Carotid Endarterectomy

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Device: GORE Flow Reversal System (GFRS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GFRS Pivotal Subjects<br>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)<br>* Carotid artery angioplasty and stenting with embolic protection<br>* Other names: Gore Neuro Protection System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Major Adverse Event (MAE) Rate | 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) | Treatment through 30-day visit window | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid artery stenosis, embolic protection device, GORE Neuro Protection System, GORE Flow Reversal System, reverse flow, proximal occlusion device, GNPS, Parodi, EMPiRE, distal embolization, minimizing risks of CAS, PAES