NCT04031001已完成不适用
Vascular No-React Graft Against Infection
Catharina Ziekenhuis Eindhoven1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2017年12月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Percentage of graft infection 3 months after implantation
研究概览
简要总结
This study seeks to demonstrate the effectiveness and safety of the Non-valved Conduit for CE marking on the basis of infection. The rationale for infection resistance with the conduit is that BioIntegral Surgical No-React® treated products have a well-documented history of infection resistance in hybrid vascular settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infected prosthetic graft and/or bifurcation
- •High risk of infection at graft implantation
- •Mycotic aneurysm
- •No alternative available
排除标准
- •Below-knee procedure
- •AV access
结局指标
主要结局
Percentage of graft infection 3 months after implantation
时间窗: 3 months after implantation
Percentage of graft infection 3 months after implantation as assessed with different infection parameters: CRP value, leukocytes, Samson classification of infection, temperature, wound healing, wound infection, purulence
次要结局
- Percentage of patency 12 months after implantation(12 months after implantation)
研究者
Marc van Sambeek
prof. dr. M.R.H.M. van Sambeek
Catharina Ziekenhuis Eindhoven
研究点 (1)
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