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NCT Number: NCT04399941

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

Hemodialysis represents a life line of patients with end stage renal disease, who are commonly maintained on hemodialysis through catheters. Prolonged exposure to these catheters eventually damages the walls of veins, which results in stenosis at the local site. This condition is called central venous stenosis (CVS) and affects number of patients on hemodialysis in the United States and can compromise the dialysis efficacy. The current diagnostic modality for CVS is venography, which has several limitations. This study proposes to examine intravenous ultrasound (IVUS) as a potentially superior modality, which will provide additional information.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Constriction, Pathologic Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Vipul Chitalia, MD PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • None

Treatment and study plan

Venography

Diagnostic Test

The venography will be performed as part of the patient's standard of care. The dialysis access will be punctured upstream of the arteriovenous anastomosis in AVF or AVG using a 4-F coaxial access set (Micro- puncture; Cook, Inc, Bloomington, Indiana). The contrast will be injected intravenously by a pump with 200 psi and a bolus of 2m/sec for total of 5 ml during upper extremity vein filming and 10 ml of contrast bolus by 3 ml/s during central vein filming while holding the breath in inspiration in anterioposterior plane.

Other names: Fistulogram

Intravascular ultrasound (IVUS)

Diagnostic Test

IVUS will be performed through the same sheath of the coaxial access set using an Eagle Eye Platinum RX digital catheter 7F over a compatible guidewire under fluoroscopic guidance. The lesion will be estimated fluoroscopically from the marker IVUS catheter in the vein and the cranial and caudal margins of stenotic lesion will be directly visualized during pullback of the IVUS catheter.

Image processing

Other

Image processing will be performed by two radiologists in a blinded manner on the images devoid of personal identifier. An adjudication committee will oversee the process and confirm their findings in case of a discrepancy.

Primary outcomes

  1. Extent of stenosis

    Time frame: 18 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.

  2. Length of lesions

    Time frame: 18 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.

  3. Morphology of lesion

    Time frame: 18 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Vipul Chitalia, MD PhD

CONTACT

[email protected]

617 638 7330

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: IVUS in ESRD

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 22, 2020
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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