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

Dialysis Access Malfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02056704
• Other study ID #: 012-088
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: July 2022

Study information

• Verified date: February 2022
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dialysis Access Malfunction

Intervention

Device:
• Angiography with IVUS
The use of IVUS to evaluate dialysis access failure.

Locations

Country	Name	City	State
United States	Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Dallas	Texas
United States	Baylor University Medical Center	Dallas	Texas
United States	Baylor Regional Medical Center at Plano	Plano	Texas
United States	The Heart Hospital Baylor Plano	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in characteristics of lesion within the vessel	This will include vessel diameters proximal and distal to lesions, percent stenosis, and lesion lengths.	every 3 months - up to 2 years