ViVEXX Carotid Revascularization Trial (VIVA)

Carotid Artery Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417963
• Other study ID #: BPV-VX-1502
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2007
• Last updated: June 21, 2011
• Start date: October 2005
• Est. completion date: March 2010

Study information

• Verified date: June 2011
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: March 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic

Intervention

Device:
• Carotid Artery Stenting
placement of a bare metal stent at sites of stenosis in the carotid artery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Number of Patients Experiencing Access Site Complications	Access site complications requiring blood transfusion (> 1 unit) or open surgical repair.	30 days following implantation	Yes
Secondary	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	Yes
Secondary	Number of Participants Experiencing Device Success	Number of participants with successful delivery and deployment of device with <50% residual stenosis.	at time of implantation	No
Secondary	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	No
Secondary	Number of Participants Experiencing Restenosis	Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.	12 months after implantation	No