PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Composite Endpoint
研究概览
简要总结
The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. If participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject provides written informed consent
- •Subject is ≥ 18 years
- •Subject is end-stage renal disease patient on hemodialysis.
- •Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU)
排除标准
- •Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement
- •Subject has a topical or subcutaneous infection associated with the implantation site
- •Subject has known or suspected systemic infection, bacteremia or septicemia
结局指标
主要结局
Composite Endpoint
时间窗: 6 months
Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia
次要结局
- Clinical Success(12 and 24 months)
- Proportion of subjects with primary patency(6, 12 and 24 months)
- Proportion of subjects with cumulative patency(6, 12, and 24 months)
- Device-related safety events(24 months)