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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:May 2012
End Date:April 2017
Contact:Tammy Fisher, RN, MBA
Email:tammyfi@baylorhealth.edu
Phone:214-820-7221

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

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.

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.

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)
We found this trial at
4
sites
Plano, Texas 75093
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
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