NCT05740410已完成不适用
Retrospective Analysis for the ClotTriever Catheter to Investigate Safety and Effectiveness in the Treatment of Acute and Subacute Iliofemoral Deep Vein Thrombosis (DVT)
Klinikum Arnsberg1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年4月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Procedural success
研究概览
简要总结
The aim of the study is to evaluate the safety and performance of the ClotTriever catheter in the treatment of patients with symptomatic iliofemoral deep vein thrombosis (DVT)
详细描述
Data from patients in whom the ClotTriever catheter was used for treatment of iliofemoral DVT was retrospectively collected for up to 6 months after the procedure for evaluation of safety and effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •uni or bilateral iliofemoral DVT
排除标准
- •previously stented in treatment vein
结局指标
主要结局
Procedural success
时间窗: directly after treatment of the vein (Day 0)
Restauration of inflow in the treated vein
次要结局
- Incidence of ClotTriever related major adverse events (MAE)(1 month)
- Vilallta score(Day 0, month 1 and 6)
- Venous clinical severity score (VCSS)(Day 0, month 1 and 6)
- Number of lesions with at least Society Interventional Radiology (SIR) Grad II Lyse (50-95% thrombus removal)(directly after treatment of the vein (Day 0))
研究者
研究点 (1)
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