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BART: Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05782062
Collaborator
Argon Medical Devices (Industry)
90
Enrollment
2
Arms
10.5
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cleaner XT
  • Device: Balloon
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacomechanical Dialysis Access Salvage With Balloon Assisted Maceration Versus Rotational Thrombectomy
Anticipated Study Start Date :
Apr 15, 2023
Anticipated Primary Completion Date :
Feb 29, 2024
Anticipated Study Completion Date :
Feb 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rotational Thrombectomy

Use of the Cleaner XT

Device: Cleaner XT
Wire like device that rotates to allow for wall to wall disruption of thrombus.
Active Comparator: Balloon Assisted maceration

Use of angioplasty balloons for balloon maceration

Device: Balloon
Use of balloon for disrupting thrombus.

Outcome Measures

Primary Outcome Measures

  1. Secondary patency [6 months post procedurally]

    How long the dialysis access remains functional after the procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Alabama at Birmingham
  • Argon Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Junaid Yasin Raja, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05782062
Other Study ID Numbers:
  • IRB-300010783
First Posted:
Mar 23, 2023
Last Update Posted:
Mar 28, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Junaid Yasin Raja, Assistant Professor, University of Alabama at Birmingham
Thrombosis of dialysis access

Study Results

No Results Posted as of Mar 28, 2023