NCT03816202已完成不适用
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal
研究概览
简要总结
The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-80 years old
- •Have undergone carotid endarterectomy with any Integra Sundt™ carotid shunt on or before date of study initiation
- •Availability of records on post-operative imaging of the carotid artery either by carotid duplex ultrasound or angiogram
排除标准
- •Insertion of a carotid shunt at the site of an infection
结局指标
主要结局
Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal
时间窗: up to 60 days post-procedure
Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal
次要结局
未报告次要终点
研究者
研究点 (3)
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