GORE Embolic Protection With Reverse Flow (EMPiRE)

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

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.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Device: GORE Flow Reversal System (GFRS)

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.

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14209
      • Millard Fillmore Gates/Univ. of Buffalo
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Gore Neuro Protection System

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Daniel Clair, M.D., The Cleveland Clinic; Principal Investigator: L. N. Hopkins, M.D., Millard Fillmore Gates/Univ. of Buffalo

Publications and helpful links

General Publications

• Parodi JC. Re: is flow reversal the best method of protection during carotid stenting? J Endovasc Ther. 2005 Jun;12(3):414-5. doi: 10.1583/05-1610L.1. No abstract available.
• Parodi JC, Schonholz C, Parodi FE, Sicard G, Ferreira LM. Initial 200 cases of carotid artery stenting using a reversal-of-flow cerebral protection device. J Cardiovasc Surg (Torino). 2007 Apr;48(2):117-24.
• Parodi JC, Schonholz C, Ferreira LM, Mendaro E, Ohki T. "Seat belt and air bag" technique for cerebral protection during carotid stenting. J Endovasc Ther. 2002 Feb;9(1):20-4. doi: 10.1177/152660280200900104.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): September 1, 2008
• Study Completion (ACTUAL): September 1, 2008

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: January 2, 2008
• First Posted (ESTIMATE): January 15, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 27, 2013
• Last Update Submitted That Met QC Criteria: December 2, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: 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
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: NPS 05-05