ViVEXX Carotid Revascularization Trial (VIVA)

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

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.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Device: Carotid Artery Stenting

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.

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: CAS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: C. R. Bard

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: January 2, 2007
• First Submitted That Met QC Criteria: January 3, 2007
• First Posted (Estimate): January 4, 2007

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: January 17, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Stenosis; Carotid; Artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: BPV-VX-1502