ViVEXX Carotid Revascularization Trial (VIVA)

C. R. Bard

Status and phase

Completed

Phase 3

Conditions

Carotid Artery Stenosis

Treatments

Device: Carotid Artery Stenting

Study type

Interventional

Funder types

Industry

Identifiers

NCT00417963

BPV-VX-1502

Details and patient eligibility

About

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.

Full description

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.

Enrollment

407 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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