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Carotid Artery StenosisPhase 3EMPiRENCT00594100

GORE Embolic Protection With Reverse Flow

A Phase 3 study testing GORE Flow Reversal System (GFRS) in people with Carotid Artery Stenosis, run by W.L.Gore & Associates at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carotid Artery Stenosis
What is being tested?
GORE Flow Reversal System (GFRS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
245 participants
Where
2 sitesUnited States
Study dates
Jul 2006to Sep 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 16Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Millard Fillmore Gates/Univ. of Buffalo

    Buffalo, New York, 14209

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
GORE Flow Reversal System (GFRS)
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
Medical subject headings
Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GORE Flow Reversal System (GFRS)Device

    Also called Gore Neuro Protection System

    Carotid artery angioplasty and stenting with embolic protection

Study groups in NCT00594100
Study groupRoleWhat they receive
GFRS Pivotal SubjectsExperimentalAll 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).
Receives: Device: GORE Flow Reversal System (GFRS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Treatment through 30-day visit window

Secondary outcomes (5)

  1. Flow Reversal System Technical Success

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

    Measured: Procedure

  2. 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.

    Measured: Procedure

  3. 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.

    Measured: Procedure

  4. 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).

    Measured: 24-48 Hours Post-Procedure

  5. 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.

    Measured: Treatment through 30-day visit window

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2008 (estimated)
  2. Study startJul 2006
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00594100
Sponsor's protocol ID
NPS 05-05
Acronym
EMPiRE
Status last verified
Dec 2013
First submitted
20 Dec 2007
Last updated
27 Dec 2013
Data monitoring committee
Yes

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.

    PubMed 15943521

  • 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.

    PubMed 17410059

  • 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.

    PubMed 11958320

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GORE Flow Reversal System (GFRS) in people with Carotid Artery Stenosis, run by W.L.Gore & Associates at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Major Adverse Event (MAE) Rate (time frame: Treatment through 30-day visit window). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00594100, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2013.

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