Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA (SONOMA)
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|ClinicalTrials.gov Identifier: NCT00478673|
Recruitment Status : Terminated (Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System.)
First Posted : May 25, 2007
Results First Posted : August 7, 2012
Last Update Posted : August 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Carotid Stenosis||Device: NexStent Carotid Stent System (Monorail Delivery System) Device: FilterWire EZ™ Embolic Protection System||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||298 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
- Device: NexStent Carotid Stent System (Monorail Delivery System)
Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
- Device: FilterWire EZ™ Embolic Protection System
Used as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
- Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE) [ Time Frame: 30 Days ]30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
- Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE) [ Time Frame: 12 Months ]12-month major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure (see 30-Day MAE above), and ipsilateral stroke events that occur within 31-365 days post-procedure.
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): NCT00478673
Show 62 Study Locations
|Principal Investigator:||Subbarao Myla, M.D.||Hoag Memorial Hospital|
|Study Director:||Pamela Grady, PhD||Boston Scientific Corporation|