ViVEXX Carotid Revascularization Trial (VIVA)
- Conditions
- Carotid Artery Stenosis
- Interventions
- Device: Carotid Artery Stenting
- Registration Number
- NCT00417963
- Lead Sponsor
- C. R. Bard
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description stent placement in the carotid artery Carotid Artery Stenting placement of a bare metal stent for treatment of carotid artery stenosis
- Primary Outcome Measures
Name Time Method Percentage of Patients Experiencing Major Adverse Events (MAE) 365 days from implantation A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure.
- Secondary Outcome Measures
Name Time Method Number of Participants Experiencing Stroke Related Neurologic Deficit 30 days from implantation Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.
Number of Participants Experiencing Device Success at time of implantation Number of participants with successful delivery and deployment of device with \<50% residual stenosis.
Number of Participants Experiencing Lesion Success at time of implantation number of participants experiencing achievement of \<50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System.
Number of Participants Experiencing Target Lesion Revascularization(s) (TLR) 12 months from implantation Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation
Number of Patients Experiencing Access Site Complications 30 days following implantation Access site complications requiring blood transfusion (\> 1 unit) or open surgical repair.
Number of Participants Experiencing Restenosis 12 months after implantation Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.