ViVEXX Carotid Revascularization Trial (VIVA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417963
|Principal Investigator:||Kenneth Rosenfield, MD||Massachusetts General Hospital|