NCT04620889已完成不适用
A Retrospective Patient Registry on the Long-Term Safety and Performance of the LifeSpan® ePTFE Vascular Graft Used in Open Vascular Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Percentage of vessels patent without requiring intervention to remain open
研究概览
简要总结
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.
详细描述
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search. Data will be captured retrospectively. Subjects will have been treated with the investigational device in the past and according to standard of care. Subjects will not be involved in any registry related procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has undergone surgical treatment with the LifeSpan.
- •Surgical treatment was for bypass or reconstruction of diseased or occluded blood vessels (PVP group) or arteriovenous shunting for blood access (AV group).
- •For PVP group: Subject's surgical treatment was at minimum 3 years ago, and maximum 10 years ago, at time of enrollment.
- •For AV group: Subject's surgical treatment was at minimum 2 years ago, and maximum 10 years ago, at time of enrollment.
排除标准
- 未提供
结局指标
主要结局
Percentage of vessels patent without requiring intervention to remain open
时间窗: 2 years
Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up
次要结局
- Procedure type(Day of procedure)
- Intra-operative technical success(Day of procedure)
- Percentage of vessels patent without requiring intervention to remain open at 1 and 5 year primary patency(1 year and 5 year)
- Percentage of vessels patent with intervention to remain open at 1 and 5 year for AV Access(2 year)
- Percentage of vessels patent with intervention to remain open at 1 and 5 year for PVP Group(3 year)
- Percentage of vessels patent with intervention to remain open at 1 and 5 year(1 year and 5 year)
研究者
研究点 (1)
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