NCT05536167已完成不适用
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Arthesys
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Efficacy endpoint
研究概览
简要总结
The purpose of this post market study is to collect clinical data of the Arthesys Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):
- •Patient with a percutaneous intervention to a native coronary, saphenous vein graft, or peripheral arteries;
- •Patient with angiographic evidence of thrombus;
- •Patient > or = 50 kg;
- •Patient >18 years;
- •Patient who understands the trial requirements and the treatment procedures and provides written informed consent.
排除标准
- •Patients will be excluded as per IFU, Hospital standard of care and GCP, also if there are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
结局指标
主要结局
Efficacy endpoint
时间窗: up to end of procedure
successful debris aspiration (macroscopic observation of the retrieved material in the filter) during the procedure.
Safety endpoint
时间窗: up to end of procedure
insertion and retrieval of the catheter up to the treated vessel without complication.
次要结局
- Performance - TIMI thrombus grade(up to end of procedure)
- Performance(up to end of procedure)
- Performance - TIMI flow grade(up to end of procedure)
- Safety - absence of Serious Adverse Event(up to end of procedure)
- Safety - absence of stroke(up to end of procedure)
- Safety - absence of complications(up to end of procedure)
研究者
研究点 (1)
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