NCT00417963

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Carotid Artery Stenting	placement of a bare metal stent at sites of stenosis in the carotid artery

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-01-01
• Completion: 2010-03-01
• First posted: 2007-01-04
• Last updated: 2017-03-01
• Results posted: 2011-07-20