Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage

Not Applicable

Withdrawn

• Conditions: Dialysis Access Malfunction; Dialysis; Complications
• Interventions: Device: Balloon; Device: Cleaner XT

• Registration Number: NCT05782062
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-03-12
• Study First Posted: 2023-03-23
• Study Start: 2023-04-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-19
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon Assisted maceration	Balloon	Use of angioplasty balloons for balloon maceration
Rotational Thrombectomy	Cleaner XT	Use of the Cleaner XT

Primary Outcome Measures

Name	Time	Method
Secondary patency	6 months post procedurally	How long the dialysis access remains functional after the procedure.