Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage

NCT ID: NCT05782062

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-15

Study Completion Date

2024-02-29

Brief Summary

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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

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Conditions

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Dialysis Access Malfunction Dialysis; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rotational Thrombectomy

Use of the Cleaner XT

Group Type EXPERIMENTAL

Cleaner XT

Intervention Type DEVICE

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

Balloon Assisted maceration

Use of angioplasty balloons for balloon maceration

Group Type ACTIVE_COMPARATOR

Balloon

Intervention Type DEVICE

Use of balloon for disrupting thrombus.

Interventions

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Cleaner XT

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

Intervention Type DEVICE

Balloon

Use of balloon for disrupting thrombus.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Argon Medical Devices

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Junaid Yasin Raja

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IRB-300010783

Identifier Type: -

Identifier Source: org_study_id

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