ViVEXX Carotid Revascularization Trial (VIVA)
ViVEXX Carotid Revascularization Trial (VIVA)
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.
Patients with clinically significant stenosis within the common and/or internal carotid
 artery who are at high risk for carotid endarterectomy and are amenable to percutaneous
 treatment including embolic protection, balloon angioplasty and the carotid stent placement.
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.

 -  High risk for carotid endarterectomy: anatomical and co-morbid.

 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