Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
A Prospective Randomized Feasibility Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
1 other identifier
interventional
66
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2014
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
February 6, 2014
CompletedStudy Start
First participant enrolled
February 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMarch 2, 2026
October 1, 2025
3.7 years
January 29, 2014
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Angiography
NO INTERVENTIONEvaluation by angiography only.
Angiography with IVUS
EXPERIMENTALEvaluation with angiography and intravascular ultrasound.
Interventions
The use of IVUS to evaluate dialysis access failure.
Eligibility Criteria
You may qualify if:
- \> 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75246, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Baylor Regional Medical Center at Plano
Plano, Texas, 75093, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Shutze, MD
Baylor Health Care System
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2014
First Posted
February 6, 2014
Study Start
February 18, 2014
Primary Completion
October 20, 2017
Study Completion
February 1, 2022
Last Updated
March 2, 2026
Record last verified: 2025-10