ViVEXX Carotid Revascularization Trial (VIVA)
|ClinicalTrials.gov Identifier: NCT00417963|
Recruitment Status : Completed
First Posted : January 4, 2007
Results First Posted : July 20, 2011
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Stenosis||Device: Carotid Artery Stenting||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||407 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||March 2010|
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
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- Number of Participants Experiencing Restenosis [ Time Frame: 12 months after implantation ]Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417963
|Principal Investigator:||Kenneth Rosenfield, MD||Massachusetts General Hospital|