The NexStent® Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction With the FilterWire EZ™ Embolic Protection System
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 298
- 试验地点
- 122
- 主要终点
- Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)
研究概览
简要总结
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.
详细描述
The SONOMA Registry will enroll approximately 300 subjects at a maximum at 78 study centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent labeling located in the Directions for Use (DFU).
排除标准
- •Subjects with contraindications as outlined in the DFU should be excluded from this registry.
结局指标
主要结局
Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点