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

Baylor Scott and White Health (BSWH)

Status and phase

Completed

Phase 4

Conditions

Dialysis Access Malfunction

Treatments

Device: Angiography with IVUS

Study type

Interventional

Funder types

Other

Identifiers

NCT02056704

012-088

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)