ViVEXX Carotid Revascularization Trial (VIVA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Device: Carotid Artery Stenting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stent placement in the carotid artery<br>placement of a bare metal stent for treatment of carotid artery stenosis | Device: Carotid Artery Stenting<br>* placement of a bare metal stent at sites of stenosis in the carotid artery<br>* Other names: CAS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Experiencing Major Adverse Events (MAE) | 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. | 365 days from implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Target Lesion Revascularization(s) (TLR) | Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation | 12 months from implantation | 
| Number of Patients Experiencing Access Site Complications | Access site complications requiring blood transfusion (> 1 unit) or open surgical repair. | 30 days following implantation | 
| Number of Participants Experiencing Stroke Related Neurologic Deficit | Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure. | 30 days from implantation | 
| Number of Participants Experiencing Device Success | Number of participants with successful delivery and deployment of device with <50% residual stenosis. | at time of implantation | 
| Number of Participants Experiencing Lesion Success | 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. | at time of implantation | 
| Number of Participants Experiencing Restenosis | Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent. | 12 months after implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid, Artery, Stenosis