Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage (BART)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Sex
Ages
Volunteers
Inclusion criteria
- End stage renal disease on hemodialysis
- Age greater than 18
- Upper extremity dialysis graft/fistula
Exclusion criteria
- Pregnant
- Incarcerated
- Age under 18
- Inability to consent for self
- Graft/fistula in a location other than upper extremity
- Peritoneal dialysis
- Catheter dialysis
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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