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

NCT04399941 | Recruiting DMC FDA Device

• 2 other identifiers: H-373961R21DK119740-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease

Keywords

intravenous ultrasound (IVUS); central venous stenosis (CVS); hemodialysis; dialysis access malfunction; fistulogram; stenosis; virtual histology (VH-IVUS) software

Outcome Measures

Primary Outcomes (3)

• Extent of stenosis

  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.

  18 months

• Length of lesions

  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.

  18 months

• Morphology of lesion

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

  18 months

Study Arms (1)

IVUS and venography group

EXPERIMENTAL

Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.

Diagnostic Test: Venography; Diagnostic Test: Intravascular ultrasound (IVUS); Other: Image processing

Interventions

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.

Also known as: Fistulogram

IVUS and venography group

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.

IVUS and venography group

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.

IVUS and venography group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Constriction, Pathologic

Interventions

Phlebography; Ultrasonography, Interventional

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angiography; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Ultrasonography; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Vipul Chitalia, MD PhD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vipul Chitalia, MD PhD

CONTACT

617 638 7330; vipul.chitalia@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: August 3, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)