NCT05517876已完成不适用
A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Primary performance endpoint
研究概览
简要总结
Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and peripheral).
Follow-up At least 1 year follow-up after surgery until a maximum of 5 years. POLYMAILLE®C vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease.
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 have objected to the collect of their data.
结局指标
主要结局
Primary performance endpoint
时间窗: 1 year
primary patency rate
Primary safety endpoint
时间窗: 30 days
mortality rate
次要结局
- Mortality rate(5 years)
- Procedural success rate(5 years)
- Primary assisted patency rate(5 years)
- Primary patency rate(5 years)
- Secondary patency rate(5 years)
- Device Failure(5 years)
- Limb salvage rate(5 years)
- Adverse events(5 years)
研究者
研究点 (1)
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