ViVEXX Carotid Revascularization Trial (VIVA)

C. R. Bard407 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

407

Conditions

Carotid Artery Stenosis

Interventions

Carotid Artery StentingDEVICE

placement of a bare metal stent at sites of stenosis in the carotid artery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 365 days from implantation

Secondary Outcomes

Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)

Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation

Time frame: 12 months from implantation

Number of Patients Experiencing Access Site Complications

Access site complications requiring blood transfusion (\> 1 unit) or open surgical repair.

Time frame: 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.

Time frame: 30 days from implantation

Number of Participants Experiencing Device Success

Number of participants with successful delivery and deployment of device with \<50% residual stenosis.

Time frame: 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.

Time frame: at time of implantation

Data from ClinicalTrials.gov

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