ViVEXX Carotid Revascularization Trial (VIVA)

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

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