Dialysis Access MalfunctionPhase 4NCT02056704
Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
A Phase 4 study testing Angiography with IVUS in people with Dialysis Access Malfunction, run by Baylor Research Institute at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis Access Malfunction
- What is being tested?
- Angiography with IVUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Feb 2014to 1 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75246
Baylor University Medical Center
Dallas, Texas, 75246
Baylor Regional Medical Center at Plano
Plano, Texas, 75093
The Heart Hospital Baylor Plano
Plano, Texas, 75093
About this study
Official title: A Prospective Randomized Feasibility 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.
Read the 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.
- Conditions
- Dialysis Access Malfunction
- Being tested
- Angiography with IVUS
- Keywords
- Dialysis Fistula, Dialysis Graft, Stenosis, Intravascular Ultrasound, Angiography
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography with IVUSDevice
Also called Volcano IVUS catheter
The use of IVUS to evaluate dialysis access failure.
| Study group | Role | What they receive |
|---|---|---|
| Angiography | No intervention | Evaluation by angiography only. |
| Angiography with IVUS | Experimental | Evaluation with angiography and intravascular ultrasound. Receives: Device: Angiography with IVUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in characteristics of lesion within the vessel
This will include vessel diameters proximal and distal to lesions, percent stenosis, and lesion lengths.
Measured: every 3 months - up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study start18 Feb 2014
- Primary completion20 Oct 2017
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Access MalfunctionStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Shutze, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056704
- Sponsor's protocol ID
- 012-088
- Status last verified
- Oct 2025
- First submitted
- 29 Jan 2014
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Feasibility Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
- ClinicalTrials.gov ID
- NCT02056704
- Acronym / sponsor ID
- 012-088
- Conditions
- Dialysis Access Malfunction
- Keywords
- Dialysis Fistula, Dialysis Graft, Stenosis, Intravascular Ultrasound, Angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 18 Feb 2014 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiography | No intervention | –Evaluation by angiography only. |
| Angiography with IVUS | Experimental | Device: Angiography with IVUSEvaluation with angiography and intravascular ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiography with IVUSAlso: Volcano IVUS catheterThe use of IVUS to evaluate dialysis access failure. | Device | Angiography with IVUS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Shutze, MD principal investigator
Baylor Health Care System
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angiography with IVUS in people with Dialysis Access Malfunction, run by Baylor Research Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in characteristics of lesion within the vessel (time frame: every 3 months - up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.