ViVEXX Carotid Revascularization Trial (VIVA)

NCT00417963 | Completed Phase 3 Results DMC

• 1 other identifier: BPV-VX-1502
• Study Type: interventional
• Target: 407
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Carotid Artery Stenosis

Keywords

Carotid; Artery; Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  12 months from implantation

• Number of Patients Experiencing Access Site Complications

  30 days following implantation

• Number of Participants Experiencing Stroke Related Neurologic Deficit

  30 days from implantation

• Number of Participants Experiencing Device Success

  at time of implantation

• Number of Participants Experiencing Lesion Success

  at time of implantation

Study Arms (1)

stent placement in the carotid artery

EXPERIMENTAL

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

Device: Carotid Artery Stenting

Interventions

Carotid Artery Stenting DEVICE

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

Also known as: CAS

stent placement in the carotid artery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• C. R. Bard: lead

MeSH Terms

Conditions

Carotid Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: C.R. Bard Inc.

john.reviere@crbard.com

480-303-2644

Study Officials

• Kenneth Rosenfield, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: October 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2010
• Last Updated: March 1, 2017
• Results First Posted: July 20, 2011

Record last verified: 2017-01