The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 298
- Locations
- 122
- Primary Endpoint
- Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)
Study Overview
Brief Summary
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.
Detailed Description
The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent labeling located in the Directions for Use (DFU).
Exclusion Criteria
- •Subjects with contraindications as outlined in the DFU should be excluded from this registry.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported