Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
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ClinicalTrials.gov Identifier: NCT02056704 |
Recruitment Status : Unknown
Verified June 2015 by Baylor Research Institute.
Recruitment status was: Recruiting
First Posted : February 6, 2014
Last Update Posted : June 23, 2015
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Condition or disease | Intervention/treatment | Phase |
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Dialysis Access Malfunction | Device: Angiography with IVUS | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Prospective Randomized Feasibility Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures |
Study Start Date : | May 2012 |
Estimated Primary Completion Date : | April 2017 |
Estimated Study Completion Date : | April 2017 |
Arm | Intervention/treatment |
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No Intervention: Angiography
Evaluation by angiography only.
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Experimental: Angiography with IVUS
Evaluation with angiography and intravascular ultrasound.
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Device: Angiography with IVUS
The use of IVUS to evaluate dialysis access failure.
Other Name: Volcano IVUS catheter |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056704
Contact: Tammy Fisher, RN, MBA | 214-820-7221 | tammyfi@baylorhealth.edu | |
Contact: Martha Mueller, RN, BSN | 214-820-7755 | martha.mueller@baylorhealth.edu |
United States, Texas | |
Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Recruiting |
Dallas, Texas, United States, 75246 | |
Principal Investigator: William Shutze, MD | |
Baylor University Medical Center | Recruiting |
Dallas, Texas, United States, 75246 | |
Principal Investigator: William Shutze, MD | |
Baylor Regional Medical Center at Plano | Recruiting |
Plano, Texas, United States, 75093 | |
Principal Investigator: William Shutze, MD | |
The Heart Hospital Baylor Plano | Recruiting |
Plano, Texas, United States, 75093 | |
Principal Investigator: William Shutze, MD |
Principal Investigator: | William Shutze, MD | Baylor Health Care System |
Responsible Party: | Baylor Research Institute |
ClinicalTrials.gov Identifier: | NCT02056704 |
Other Study ID Numbers: |
012-088 |
First Posted: | February 6, 2014 Key Record Dates |
Last Update Posted: | June 23, 2015 |
Last Verified: | June 2015 |
Dialysis Fistula Dialysis Graft Stenosis Intravascular Ultrasound Angiography |