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NCT05782062 Clinical Trial

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Clinical Trial Details — Status: Withdrawn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
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design

Related Conditions & MeSH terms

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
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