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Clinical Trials/NCT04399941
NCT04399941
Recruiting
Not Applicable

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

Boston Medical Center1 site in 1 country50 target enrollmentAugust 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Renal Disease
Sponsor
Boston Medical Center
Enrollment
50
Locations
1
Primary Endpoint
Morphology of lesion
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 3, 2021
End Date
September 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Morphology of lesion

Time Frame: 18 months

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

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.

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.

Study Sites (1)

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