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GORE Embolic Protection With Reverse Flow (EMPiRE)

Primary Purpose

Carotid Artery Stenosis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

GORE Flow Reversal System (GFRS)

About this trial

This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Millard Fillmore Gates/Univ. of Buffalo
Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GFRS Pivotal Subjects

Arm Description

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Flow Reversal System Technical Success

Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting 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.

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.

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).

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.

Full Information

NCT ID

NCT00594100

First Posted

December 20, 2007

Last Updated

December 2, 2013

Sponsor

W.L.Gore & Associates

1. Study Identification

Unique Protocol Identification Number

NCT00594100

Brief Title

GORE Embolic Protection With Reverse Flow

Acronym

EMPiRE

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 Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

W.L.Gore & Associates

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Artery Stenosis

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

245 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GFRS Pivotal Subjects

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

GORE Flow Reversal System (GFRS)

Other Intervention Name(s)

Gore Neuro Protection System

Intervention Description

Carotid artery angioplasty and stenting with embolic protection

Primary Outcome Measure Information:

Title

Composite Major Adverse Event (MAE) Rate

Description

Time Frame

Treatment through 30-day visit window

Secondary Outcome Measure Information:

Title

Flow Reversal System Technical Success

Description

Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure)

Time Frame

Procedure

Title

Flow Reversal System Success

Description

Time Frame

Procedure

Title

Stent Success

Description

Time Frame

Procedure

Title

Clinical Success

Description

Time Frame

24-48 Hours Post-Procedure

Title

Patency at 30 Days

Description

Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.

Time Frame

Treatment through 30-day visit window

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Clair, M.D.

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

L. N. Hopkins, M.D.

Organizational Affiliation

Millard Fillmore Gates/Univ. of Buffalo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Millard Fillmore Gates/Univ. of Buffalo

City

Buffalo

State/Province

New York

ZIP/Postal Code

14209

Country

United States

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15943521

Citation

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.

Results Reference

background

PubMed Identifier

17410059

Citation

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.

Results Reference

background

PubMed Identifier

11958320

Citation

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.

Results Reference

background

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GORE Embolic Protection With Reverse Flow

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