GORE Embolic Protection With Reverse Flow

NCT ID: NCT00594100

Last Updated: 2013-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-09-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

GORE Flow Reversal System (GFRS)

Intervention Type: DEVICE

Carotid artery angioplasty and stenting with embolic protection

Interventions

GORE Flow Reversal System (GFRS)

Carotid artery angioplasty and stenting with embolic protection

Intervention Type: DEVICE

Other Intervention Names

Gore Neuro Protection System

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)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Clair, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

L. N. Hopkins, M.D.

Role: PRINCIPAL_INVESTIGATOR

Millard Fillmore Gates/Univ. of Buffalo

Locations

Millard Fillmore Gates/Univ. of Buffalo

Buffalo, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15943521 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17410059 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11958320 (View on PubMed)

Other Identifiers

NPS 05-05

Identifier Type: -

Identifier Source: org_study_id