Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage

NCT05782062 | Withdrawn FDA Device

• 1 other identifier: IRB-300010783
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dialysis Access Malfunction; Dialysis; Complications

Keywords

Thrombosis of dialysis access

Outcome Measures

Primary Outcomes (1)

• Secondary patency

  How long the dialysis access remains functional after the procedure.

  6 months post procedurally

Study Arms (2)

Rotational Thrombectomy

EXPERIMENTAL

Use of the Cleaner XT

Device: Cleaner XT

Balloon Assisted maceration

ACTIVE COMPARATOR

Use of angioplasty balloons for balloon maceration

Device: Balloon

Interventions

Cleaner XT DEVICE

Wire like device that rotates to allow for wall to wall disruption of thrombus.

Rotational Thrombectomy

Balloon DEVICE

Use of balloon for disrupting thrombus.

Balloon Assisted maceration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End stage renal disease on hemodialysis
• Age greater than 18
• Upper extremity dialysis graft/fistula

You may not qualify if:

• Pregnant
• Incarcerated
• Age under 18
• Inability to consent for self
• Graft/fistula in a location other than upper extremity
• Peritoneal dialysis
• Catheter dialysis

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Argon Medical Devices: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 23, 2023
• Study Start: April 15, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05