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Completed

NCT Number: NCT02056704

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Angiography with IVUS

Device

The use of IVUS to evaluate dialysis access failure.

Other names: Volcano IVUS catheter

Primary outcomes

  1. Change in characteristics of lesion within the vessel

    Time frame: every 3 months - up to 2 years

    This will include vessel diameters proximal and distal to lesions, percent stenosis, and lesion lengths.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2022
First posted
Feb 6, 2014
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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