Status:
COMPLETED
ViVEXX Carotid Revascularization Trial (VIVA)
Lead Sponsor:
C. R. Bard
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 patien...
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 embo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00417963
Start Date
October 1 2005
End Date
March 1 2010
Last Update
March 1 2017
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