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

Study Overview
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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.

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.

Official Title
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A Prospective Randomized Feasibility Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures

Conditions
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Dialysis Access Malfunction

Intervention / Treatment
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* Device: Angiography with IVUS


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Angiography<br>Evaluation by angiography only. | |
| Experimental: Angiography with IVUS<br>Evaluation with angiography and intravascular ultrasound. | Device: Angiography with IVUS<br>* The use of IVUS to evaluate dialysis access failure.<br>* Other names: Volcano IVUS catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in characteristics of lesion within the vessel | This will include vessel diameters proximal and distal to lesions, percent stenosis, and lesion lengths. | every 3 months - up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis Fistula, Dialysis Graft, Stenosis, Intravascular Ultrasound, Angiography