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Intravascular Ultrasound for Dialysis Access Malfunction

This study is looking at a new way to diagnose problems with dialysis access in patients with end-stage renal disease (ESRD). Currently, doctors use a test called venography, but it has some limitations. This study will compare venography with a different diagnostic tool called Intravascular Ultrasound (IVUS). Both tests will be performed during a standard diagnostic procedure for dialysis access malfunction. Researchers want to see if IVUS can provide more detailed information about blockages (stenosis) in the veins. They will measure the size and type of blockages at 18 months. You may be able to join if you have ESRD, are receiving hemodialysis at Boston Medical Center, and are having a diagnostic procedure for a dialysis access malfunction. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 50 participants. It compares two diagnostic tests: venography and Intravascular Ultrasound (IVUS).
What's involved
You would undergo venography and Intravascular Ultrasound (IVUS) as part of your standard diagnostic procedure for dialysis access malfunction. Images from these tests will be processed by radiologists.
Compensation
Not stated in the trial record.
Follow-up
The extent, length, and morphology of lesions will be measured at 18 months.

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NCT04399941

Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis

Recruiting
NAAges 18–85InterventionalDiagnostic
Boston Medical Center
~50 participants
Updated 2025-12-01 on ClinicalTrials.gov
What's tested:VenographyIntravascular ultrasound (IVUS)Image processing

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Extent of stenosis
Measured over 18 months
+2 more outcomes measured

Conditions

End Stage Renal Disease

Explore related trials

Central Venous StenosisChronic Kidney Disease, Stage 5Dialysis Access Malfunction

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Vipul Chitalia, MD PhD · PRINCIPAL_INVESTIGATOR · Boston Medical Center

Who to contact

Vipul Chitalia, MD PhD
[email protected]
617 638 7330
Email the study team

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Eligibility criteria

Inclusion

ESRD (end stage renal disease) patients at BMC (Boston Medical Center)
Receiving hemodialysis
Has a dialysis access malfunction
Undergoing a diagnostic fistulogram for the dialysis access malfunction

Exclusion

None

What this trial measures

  • Extent of stenosis18 months

    The severity of venous stenosis will be assessed using venogram and IVUS results. It will be calculated as the percentage diameter or area reduction, expressed as the ratio of the MLD or MLA to the RVD or RVA.

  • Length of lesions18 months

    The length of each lesion will be measured between points with \>50% diameter reduction in comparison to the referenced vein diameter and the referenced vein area at the pre-stenotic venous segment.

  • Morphology of lesion18 months

    The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.