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| Name | Class |
|---|---|
| Argon Medical Devices | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotational Thrombectomy | Experimental | Use of the Cleaner XT |
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| Balloon Assisted maceration | Active Comparator | Use of angioplasty balloons for balloon maceration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cleaner XT | Device | Wire like device that rotates to allow for wall to wall disruption of thrombus. |
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| Measure | Description | Time Frame |
|---|---|---|
| Secondary patency | How long the dialysis access remains functional after the procedure. | 6 months post procedurally |
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Inclusion Criteria:
Exclusion Criteria:
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| Balloon | Device | Use of balloon for disrupting thrombus. |
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