Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage

Dialysis; Complications Clinical Trial

— BART  

Official title:

Pharmacomechanical Dialysis Access Salvage With Balloon Assisted Maceration Versus Rotational Thrombectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05782062
• Other study ID #: IRB-300010783
• Status: Withdrawn
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: May 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis Access Malfunction
• Dialysis; Complications

Intervention

Device:
• Cleaner XT
Wire like device that rotates to allow for wall to wall disruption of thrombus.
• Balloon
Use of balloon for disrupting thrombus.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Argon Medical Devices

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary patency	How long the dialysis access remains functional after the procedure.	6 months post procedurally