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ViVEXX Carotid Revascularization Trial (VIVA)

This study has been completed.
Sponsor:
Information provided by:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00417963
First received: January 2, 2007
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Carotid Artery Stenosis
 Device: Carotid Artery Stenting
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Percentage of Patients Experiencing Major Adverse Events (MAE) [ Time Frame: 365 days from implantation ] [ Designated as safety issue: Yes ]
    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:
  • Number of Participants Experiencing Target Lesion Revascularization(s) (TLR) [ Time Frame: 12 months from implantation ] [ Designated as safety issue: Yes ]
    Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation

  • Number of Patients Experiencing Access Site Complications [ Time Frame: 30 days following implantation ] [ Designated as safety issue: Yes ]
    Access site complications requiring blood transfusion (> 1 unit) or open surgical repair.

  • Number of Participants Experiencing Stroke Related Neurologic Deficit [ Time Frame: 30 days from implantation ] [ Designated as safety issue: Yes ]
    Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.

  • Number of Participants Experiencing Device Success [ Time Frame: at time of implantation ] [ Designated as safety issue: No ]
    Number of participants with successful delivery and deployment of device with <50% residual stenosis.

  • Number of Participants Experiencing Lesion Success [ Time Frame: at time of implantation ] [ Designated as safety issue: No ]
    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 Restenosis [ Time Frame: 12 months after implantation ] [ Designated as safety issue: No ]
    Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.


Enrollment: 407
Study Start Date: October 2005
Study Completion Date: March 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stent placement in the carotid artery
placement of a bare metal stent for treatment of carotid artery stenosis
 Device: Carotid Artery Stenting
placement of a bare metal stent at sites of stenosis in the carotid artery
Other Name: CAS

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417963

Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: John Reviere, Director, Clinical Affairs, Bard Peripheral Vascular
ClinicalTrials.gov Identifier: NCT00417963     History of Changes
Other Study ID Numbers: BPV-VX-1502
Study First Received: January 2, 2007
Results First Received: April 16, 2011
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
Carotid
Artery
Stenosis

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013