Post Market Clinical Follow-Up Registry Study of the aXess Hemodialysis Conduit (aXess4All)
Prospective, Single Arm, Non-randomized PMCF Registry Study to Evaluate the Safety and Performance of the aXess Hemodialysis Conduit.
A prospective, single arm, non-randomized Post Market Clinical Follow-up (PMCF) registry study to evaluate the safety and performance of the aXess Hemodialysis Conduit, called aXess4All. Intended for Patients older than 18 years of age with end-stage renal disease who require a vascular access for hemodialysis, compliant with the Instructions for Use who consented in study participation.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Patients older than 18 years of age with end-stage renal disease who require a vascular access for hemodialysis, compliant with the Instructions for Use who consented in study participation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：aXess
|
The aXess Hemodialysis Conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess Hemodialysis Conduit is able to support both straight and loop configurations and may be implanted in the upper arm or forearm. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Freedom from major aXess infection
大体时间：12 months post-implant
|
Major aXess infection defined as conduit-related infections resulting in (partial) aXess Hemodialysis Conduit explantation. |
12 months post-implant
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary, primary-assisted and secondary patency
大体时间：6, 12, 24, 36, 48 months post-implant
|
Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency. Assisted primary patency: Defined as the interval between vascular access creation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality of the vascular access. Secondary patency: Defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up). |
6, 12, 24, 36, 48 months post-implant
|
|
Freedom from major aXess infection
大体时间：6, 24, 36, 48 months post-implant
|
Major aXess infection defined as conduit-related infections resulting in (partial) aXess Hemodialysis Conduit explantation. |
6, 24, 36, 48 months post-implant
|
|
Rate of interventions to maintain or restore patency
大体时间：6, 12, 24, 36, 48 months post-implant
|
6, 12, 24, 36, 48 months post-implant
|
|
|
Rate of interventions to treat pseudoaneurysms
大体时间：6, 12, 24, 36, 48 months post-implant
|
6, 12, 24, 36, 48 months post-implant
|
|
|
Rate of treatment failures
大体时间：Day 0 post-implant
|
Treatment failure defined as patients that had an implant attempted but are discharged without a functional aXess Hemodialysis Conduit |
Day 0 post-implant
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- XEL-CR-16
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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