NCT05071872已完成不适用
Retrospective Post-Market Clinical Follow Up of Rotarex®S & Aspirex®S Catheters in Treating Thrombotic Occlusion of Arteriovenous Graft for Dialysis Access (Artificial Bypass)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
Retrospective Post-Market Clinical Follow Up of Rotarex®S & Aspirex®S Catheters in treating thrombotic occlusion of Arteriovenous Graft for dialysis access (Artificial Bypass)
详细描述
To evaluate the safety, technical performance, and clinical efficacy of the Rotarex®S & Aspirex®S Catheters as a stand-alone and adjunctive therapy for the treatment of acute thrombotic occlusion of arteriovenous graft for dialysis access (Artificial Bypass) in accordance with Rotarex®S & Aspirex®S Catheters intended use.
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
- •Female or male subject with a minimum age of 18 years
- •Treatment performed between 2013 and 2020
- •Occlusion in arteriovenous graft
- •For the Rotarex®S group: use of Rotarex®S Catheter
- •For the Aspirex®S group: use of Aspirex®S Catheter
排除标准
- •Subjects not appropriate for this study according to the opinion of the principal investigator
结局指标
主要结局
Technical success
时间窗: Day 1
defined as removal of thrombotic occlusion in AV-G with Rotarex®S or Aspirex®S Catheter
次要结局
- Procedural success(Day 1)
- Primary and Secondary Patency(10 days, 1, 3 and 6 months)
- (SAEs) Serious Adverse events Rate(6 months)
- Procedure-related Adverse events Rate(6 months)
- (ADEs) Adverse device effects Rate(6 months)
- Successful use of AV-Graft as dialysis access(Up to 14 days)
- (SADEs) Serious Adverse Device Effects Rate(6 months)
研究者
研究点 (1)
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