GORE Embolic Protection With Reverse Flow

Completed · Phase 3

Conditions studied: Carotid Artery Stenosis

In brief

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.

Key facts

Study ID

NCT00594100

Run by

W.L.Gore & Associates

People needed

245

Starts

2006-07-01

Expected to finish

2008-09-01

Last updated by the study team

2013-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Millard Fillmore Gates/Univ. of Buffalo — Buffalo, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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