跳至主要内容
临床试验/NCT05782062
NCT05782062撤回不适用

Pharmacomechanical Dialysis Access Salvage With Balloon Assisted Maceration Versus Rotational Thrombectomy

University of Alabama at Birmingham0 个研究点开始时间: 2023年4月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Junaid Yasin Raja

Assistant Professor

University of Alabama at Birmingham

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