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GORE Embolic Protection With Reverse Flow (EMPiRE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00594100
First received: December 20, 2007
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Carotid Artery Stenosis
Device: GORE Flow Reversal System (GFRS)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Composite Major Adverse Event (MAE) Rate [ Time Frame: Treatment through 30-day visit window ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Procedure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.


Enrollment: 245
Study Start Date: July 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594100

Locations
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
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00594100     History of Changes
Other Study ID Numbers: NPS 05-05
Study First Received: December 20, 2007
Results First Received: March 19, 2009
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by W.L.Gore & Associates:
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:
Carotid Stenosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014