At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 407 enrolled
Drug / intervention
Carotid Artery Stentingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Carotid Artery Stenting for Carotid Artery Stenosis. Completed, enrolled 407 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Artery Stenosis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
First PostedJan 2007
Primary CompletionJan 2009
Study CompletionMar 2010
TodayJul 2026
First PostedJan 4, 2007
Enrollment StartOct 1, 2005
Primary CompletionJan 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.5 years ago
Interventions
Carotid Artery Stentingdevice
placement of a bare metal stent at sites of stenosis in the carotid artery