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Completed

NCT Number: NCT00417963

ViVEXX Carotid Revascularization Trial (VIVA)

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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Key information

Conditions

Carotid Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Constriction, Pathologic Nervous System Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carotid artery stenting

Device

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

Other names: CAS

Primary outcomes

  1. Percentage of Patients Experiencing Major Adverse Events (MAE)

    Time frame: 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 outcomes

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

    Time frame: 12 months from implantation

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

  2. Number of Patients Experiencing Access Site Complications

    Time frame: 30 days following implantation

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

  3. Number of Participants Experiencing Stroke Related Neurologic Deficit

    Time frame: 30 days from implantation

    Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.

  4. Number of Participants Experiencing Device Success

    Time frame: at time of implantation

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

  5. Number of Participants Experiencing Lesion Success

    Time frame: 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.

  6. Number of Participants Experiencing Restenosis

    Time frame: 12 months after implantation

    Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Jan 4, 2007
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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