NCT05782062

Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage

Pharmacomechanical Dialysis Access Salvage With Balloon Assisted Maceration Versus Rotational Thrombectomy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dialysis Access Malfunction
• Dialysis; Complications

Interventions

Type	Name	Description
DEVICE	Cleaner XT	Wire like device that rotates to allow for wall to wall disruption of thrombus.
DEVICE	Balloon	Use of balloon for disrupting thrombus.

Timeline

• Start date: 2023-04-15
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2023-03-23
• Last updated: 2023-05-19

Regulatory

• FDA-regulated device study