Dialysis Access Malfunction, Dialysis; Complications
Conditions
Keywords
Thrombosis of dialysis access
Brief summary
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.
Interventions
DEVICECleaner XT
Wire like device that rotates to allow for wall to wall disruption of thrombus.
DEVICEBalloon
Use of balloon for disrupting thrombus.
Sponsors
Argon Medical Devices
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secondary patency | 6 months post procedurally | How long the dialysis access remains functional after the procedure. |
Outcome results
None listed