Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-18

Study Completion Date

2022-02-01

Brief Summary

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The reason the investigators are doing this study is to compare the results of angiography versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are blocked.

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Detailed Description

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Patients with kidney failure have a fistula or graft for long-term dialysis in order for the dialysis machine to draw blood, filter it, and give it back to the patient. Over time, the fistula or graft may not work well enough to use for dialysis, most commonly because the veins may develop "scar tissue" within and around them that narrows the vein resulting in poor flow or complete blockage.

These blockages are commonly opened with wires, balloons (a procedure called angioplasty), and stents. These blockages are seen with angiography, a special type of x-ray used with a dye that shows the inside of the blood vessels. Intravascular ultrasound (IVUS) is a type of imaging that uses sound waves to produce an image of the inside of blood vessels and to see their condition. Currently, it is not known if angiography alone or angiography with IVUS has better results. The reason we are doing this study is to compare the results of angiography versus angiography with IVUS.

Conditions

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Dialysis Access Malfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Angiography

Evaluation by angiography only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Angiography with IVUS

Evaluation with angiography and intravascular ultrasound.

Group Type EXPERIMENTAL

Angiography with IVUS

Intervention Type DEVICE

The use of IVUS to evaluate dialysis access failure.

Interventions

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Angiography with IVUS

The use of IVUS to evaluate dialysis access failure.

Intervention Type DEVICE

Other Intervention Names

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Volcano IVUS catheter

Eligibility Criteria

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Inclusion Criteria

* \> 18 years old
* Male or female (non-pregnant females)
* Patients with hemodialysis access failure (arteriovenous fistulae or arteriovenous grafts)
* Patients must undergo elective angiographies (fistulograms) based on surveillance duplex ultrasound findings (stenosis)
* Patients with outflow stenoses between 1 cm distal to an arterial anastamosis and clavicle in AV fistulae or between venous anastamosis and clavicle in AV grafts found on surveillance duplex ultrasound

Exclusion Criteria

* Patients with other etiologies (inflow lesions, intragraft lesions, hypercoagulable states, lesions not readily amenable to stenting), advanced failures (thrombosis, central venous occlusion), and non-routine access conformations (chest wall/groin grafts, balloon assisted maturation)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No