ViVEXX Carotid Revascularization Trial (VIVA)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-03-31

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.

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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.

Conditions

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Carotid Artery Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stent placement in the carotid artery

placement of a bare metal stent for treatment of carotid artery stenosis

Group Type EXPERIMENTAL

Carotid Artery Stenting

Intervention Type DEVICE

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

Interventions

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Carotid Artery Stenting

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

Intervention Type DEVICE

Other Intervention Names

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CAS

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No