ClotTriever® Thrombectomy System Use-Result Survey in Japan
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 17
- 主要终点
- Rate of Major Adverse Events
研究概览
简要总结
The objective of this survey is to determine the safety and efficacy of the ClotTriever Thrombectomy System under daily clinical practice after marketing approval in Japan.
This device was designated as a subject of use results evaluation at the time of application for manufacturing and marketing approval.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This is an all-comers survey of all patients treated with ClotTriever® Thrombectomy System in Japan.
排除标准
- 未提供
研究组 & 干预措施
Full Analysis Population
All subjects who the survey device entered their vasculature.
干预措施: ClotTriever® Thrombectomy System (Device)
结局指标
主要结局
Rate of Major Adverse Events
时间窗: Through 30 days post index procedure.
Rate of Major Adverse Events \[All-cause mortality, Major bleeding, New symptomatic Pulmonary Embolism (PE) documented by Computed Tomography Pulmonary Angiography (CTPA), Rethrombosis of a Target Venous Segment\].
Technical Success
时间窗: During the index procedure
Thrombus residual volume assessed by the the treating physician using pre- and post-procedure venography to evaluate the success of thrombus removal.
次要结局
未报告次要终点