Pharmacomechanical Dialysis Access Salvage With Balloon Assisted Maceration Versus Rotational Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Secondary patency
研究概览
简要总结
The purpose of this research study is to compare how well a wire like device disrupts and removes blood clot in your blocked dialysis graft/fistula in comparison to inflating a balloon in your access for the same purpose. The wire like device is called the Cleaner XT and has already been approved by the government/Food and Drug Administration (FDA) for this purpose.
Blood clots in your dialysis access can be fairly common and prevent you from being able to get dialysis. Procedures for opening this blockage must then be performed which is why you have been sent to the hospital today. There are different ways of opening up this blockage which can including blowing up a balloon in multiple areas of the graft/fistula to squeeze the blood clot to break up the blockage or using a wire like device to break up the clot in small pieces and try to remove all of the clot from the wall of the graft/fistula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •End stage renal disease on hemodialysis
- •Age greater than 18
- •Upper extremity dialysis graft/fistula
排除标准
- •Incarcerated
- •Age under 18
- •Inability to consent for self
- •Graft/fistula in a location other than upper extremity
- •Peritoneal dialysis
- •Catheter dialysis
结局指标
主要结局
Secondary patency
时间窗: 6 months post procedurally
How long the dialysis access remains functional after the procedure.
次要结局
未报告次要终点
研究者
Junaid Yasin Raja
Assistant Professor
University of Alabama at Birmingham
