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Intravascular Ultrasound for Kidney Failure (IVUS in ESRD Trial)

N/A
Recruiting
Led By Vipul Chitalia, MD PhD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ESRD (end stage renal disease) patients at BMC (Boston Medical Center)
Undergoing a diagnostic fistulogram for the dialysis access malfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if IVUS is a better diagnostic tool than venography for central venous stenosis (CVS) in people with end stage renal disease.

Who is the study for?
This trial is for patients with end-stage renal disease on hemodialysis at Boston Medical Center who are experiencing dialysis access malfunctions and require a diagnostic fistulogram.
What is being tested?
The study is testing the use of intravascular ultrasound (IVUS) as a potentially better way to diagnose central venous stenosis in comparison to the current standard, venography. IVUS may provide more detailed images of veins.
What are the potential side effects?
While specific side effects are not listed, procedures like IVUS and venography might cause discomfort, bruising or bleeding at the insertion site, and very rarely, infection or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have advanced kidney disease and am a patient at Boston Medical Center.
Select...
I am scheduled for a test to check my dialysis access for problems.
Select...
I am currently on hemodialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Extent of stenosis
Length of lesions
Morphology of lesion

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IVUS and venography groupExperimental Treatment3 Interventions
Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
405 Previous Clinical Trials
884,911 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,403 Total Patients Enrolled
10 Trials studying Kidney Failure
10,720 Patients Enrolled for Kidney Failure
Vipul Chitalia, MD PhDPrincipal InvestigatorBoston Medical Center

Media Library

Intravascular ultrasound (IVUS) Clinical Trial Eligibility Overview. Trial Name: NCT04399941 — N/A
Kidney Failure Research Study Groups: IVUS and venography group
Kidney Failure Clinical Trial 2023: Intravascular ultrasound (IVUS) Highlights & Side Effects. Trial Name: NCT04399941 — N/A
Intravascular ultrasound (IVUS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04399941 — N/A
~12 spots leftby Dec 2025
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