Clinical trial NCT00594100: GORE Embolic Protection With Reverse Flow
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
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Composite Major Adverse Event (MAE) Rate
timeFrame: Treatment through 30-day visit window
Secondary outcomes:
measure: Flow Reversal System Technical Success
timeFrame: Procedure
measure: Flow Reversal System Success
timeFrame: Procedure
measure: Stent Success
timeFrame: Procedure
measure: Clinical Success
timeFrame: 24-48 Hours Post-Procedure
measure: Patency at 30 Days
timeFrame: Treatment through 30-day visit window
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Millard Fillmore Gates/Univ. of Buffalo
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel Clair, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Millard Fillmore Gates/Univ. of Buffalo
name: L. N. Hopkins, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.