GORE Embolic Protection With Reverse Flow (EMPiRE)
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|ClinicalTrials.gov Identifier: NCT00594100|
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : May 5, 2009
Last Update Posted : December 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Stenosis||Device: GORE Flow Reversal System (GFRS)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||245 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
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
- Composite Major Adverse Event (MAE) Rate [ Time Frame: 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)
- Flow Reversal System Technical Success [ Time Frame: Procedure ]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 ]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 ]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 ]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 ]Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594100
|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|