ViVEXX Carotid Revascularization Trial (VIVA) for High Surgical Risk Patients With Extracranial Carotid Artery Stenosis Using the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System

Carotid Artery Disease - VIVA

Trial Sponsor
C. R. Bard

Principal Investigator
Gregory J. Mishkel, MD

Trial Name
The ViVEXX Carotid Revascularization Trial (VIVA) for High Surgical Risk Patients With Extracranial Carotid Artery Stenosis Using the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System

Purpose
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy.

Phase
Phase III

Study Type
Interventional

Study Design
Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Eligibility

Ages Eligible for Study
18 - 85 Years

Genders Eligible for Study
Both

Inclusion Criteria

The patient has a symptomatic or asymptomatic carotid artery stenosis that meets one of the following criteria:

Symptomatic: > than or = to 50% carotid stenosis by angiography and a history of non-disabling stroke, transient ischemic attack (TIA) in the hemisphere supplied by the target vessel within 180 days of the procedure.
Asymptomatic: > than or = to 80% carotid stenosis by angiography without neurological symptoms.

Exclusion Criteria

History of symptoms of stroke or TIA within 24 hours of the procedure
Extensive or diffuse atherosclerotic disease
Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device

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