Recruiting

Intravascular Ultrasound

Sponsor:

Boston Medical Center

Code:

NCT04399941

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Venography

Intravascular ultrasound (IVUS)

Image processing

Study Details

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

Study ID

NCT04399941

Start date

Aug 3, 2021

Status verified date

Nov, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: IVUS and venography group

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

Interventions

Venography

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.

Intravascular ultrasound (IVUS)

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

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 outcome measure

  • Extent of stenosis [ Time Frame: 18 months ]
  • Length of lesions [ Time Frame: 18 months ]
  • Morphology of lesion [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Vipul Chitalia, MD PhD

617 638 7330vipul.chitalia@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Vipul Chitalia, MD PhD

vipul.chitalia@bmc.org

More Information

Sponsor

Boston Medical Center

Last update posted

Dec 1, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2025-12-01.