NCT05519826已完成不适用
A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- Primary safety endpoint
研究概览
简要总结
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.
the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.
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
- •Patients must meet all the following inclusion criteria in order to be eligible for inclusion in the study:
- •Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death
排除标准
- •Patients who refused the collection of their personal data.
结局指标
主要结局
Primary safety endpoint
时间窗: 1 year
limb salvage rate
Primary performance endpoint
时间窗: 1 year
primary patency rate
次要结局
- Procedural success rate(5 years)
- Primary assisted patency rate(5 years)
- -Secondary patency rate(5 years)
- Adverse events(5 years)
- Primary patency rate(5 years)
- Device Failure(5 years)
- Limb salvage rate(5 years)
- Mortality rate(5 years)
研究者
研究点 (1)
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