The primary objective of the SONOMA Registry is to confirm the safety of the NexStent® Carotid Stent System and FilterWire EZ™ Embolic Protection System in routine clinical practice and to identify rare or unanticipated device-related events that might occur.
The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
298
Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
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)
30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Time frame: 30 Days
Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)
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.
Time frame: 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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