Clinical trial NCT02056704: Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
Official title: A Prospective Randomized Feasibility Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dialysis Access Malfunction
Keywords: Dialysis Fistula
Dialysis Graft
Stenosis
Intravascular Ultrasound
Angiography
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in characteristics of lesion within the vessel
timeFrame: every 3 months - up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Plano
country: United States
facility: Baylor Regional Medical Center at Plano
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: William Shutze, MD
role: PRINCIPAL_INVESTIGATOR
References: