Intravascular Ultrasound for Kidney Failure
(IVUS in ESRD Trial)
Recruiting in Palo Alto (17 mi)
Overseen byVipul Chitalia, MD PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Medical Center
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Intravascular Ultrasound for Kidney Failure?
Intravascular ultrasound (IVUS) has been shown to provide detailed images of blood vessels, which can help in assessing conditions like atherosclerosis (hardening of the arteries) in various parts of the body, including the renal arteries. This suggests that IVUS could be useful in evaluating and potentially improving treatment outcomes for kidney-related vascular issues.
12345Is intravascular ultrasound (IVUS) safe for use in humans?
Intravascular ultrasound (IVUS) has been used safely in various medical procedures, including heart and blood vessel interventions, without the need for contrast dye, which can be harmful to the kidneys. Clinical trials have shown that IVUS can reduce the risk of kidney-related side effects, making it a safer option for patients with kidney issues.
15678How does intravascular ultrasound differ from other treatments for kidney failure?
Intravascular ultrasound (IVUS) is unique because it uses high-resolution imaging to assess the inside of blood vessels, providing detailed information about the vessel walls and any blockages. Unlike traditional treatments for kidney failure, which may focus on managing symptoms or dialysis, IVUS offers a way to visualize and potentially address underlying vascular issues that could be contributing to kidney problems.
345910Eligibility Criteria
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.Inclusion Criteria
I have advanced kidney disease and am a patient at Boston Medical Center.
I am scheduled for a test to check my dialysis access for problems.
You have a problem with your dialysis access.
+1 more
Exclusion Criteria
N/A
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing
18 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Medical CenterBoston, MA
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Who Is Running the Clinical Trial?
Boston Medical CenterLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Intravascular ultrasound as an alternative to positive-contrast vena cavography prior to filter placement. [2019]In a nonconsecutive series of patients, intravascular ultrasound (IVUS) was investigated for safety and efficacy as an alternative to positive-contrast vena cavography for evaluating the inferior vena cava (IVC) prior to filter placement.
Intravascular Ultrasound-Guided Versus Angiography-Guided Endovascular Therapy for Femoropopliteal Artery Disease: A Scoping Review. [2023]The objective of this study was to summarize whether the application of additional intravascular ultrasound (IVUS) can change the outcomes of endovascular treatment in femoropopliteal atherosclerotic lesions compared with conventional angiography alone based on the existing study and evidence.
Intravascular ultrasound imaging of atherosclerotic renal arteries: comparison between in vitro and in vivo studies. [2019]Intravascular ultrasound (IVUS) imaging, a new modality, may be feasible and useful for the assessment of atherosclerotic renal arteries. However, comparison between in vivo and in vitro studies to confirm pathological changes corresponding with IVUS findings obtained from renal arteries was not fully evaluated.
In vitro correlation of intravascular ultrasound and direct magnification radiography for calcified arterial lesions. [2019]Intravascular ultrasound (IVUS) is an adjunct to contrast angiography that gives additional information concerning the morphology of the vascular wall. The authors examined the accuracy of intravascular ultrasound (IVUS) in the evaluation of calcified lesions within the abdominal aorta and the iliac artery.
Fast-marching segmentation of three-dimensional intravascular ultrasound images: a pre- and post-intervention study. [2017]Intravascular ultrasound (IVUS) is a vascular imaging technique that is used to study atherosclerosis since it has the ability to show the lumen and the vessel wall. Cross-sectional images of blood vessels are produced and they provide quantitative assessment of the vascular wall, information about the nature of atherosclerotic lesions, as well as the plaque shape and size. Due to the ultrasound speckle, catheter artifacts, or calcification shadows, the automated analysis of large IVUS data sets represents an important challenge.
Intravascular ultrasound for transvenous interventions. [2016]Since the development of intravascular ultrasound in the late 1980s, the modality has been used both to image the vascular system and to direct interventions in target vessels. Intravascular ultrasound (IVUS) was initially used to image atherosclerosis and aid in its treatment, but it has more recently been employed within the venous system, allowing for both intravenous and transvenous image-guided interventions. IVUS is now used for both direct and transjugular intrahepatic portosystemic shunt placement, for transcaval liver biopsy and transcaval puncture of type II endoleaks, and for cardiac mass biopsy, among other interventions. The use of IVUS not only yields potential for reduced fluoroscopy dose in and increased safety of established procedures, but it also allows for the development of altogether new procedures.
Intravascular Imaging in Ultra-Low or Zero-Contrast Percutaneous Coronary Interventions: The Time Is Now? [2023]Ultra-low contrast percutaneous coronary interventions (ULPCIs) are a novel field of interventional cardiology, aiming to reduce the risk of contrast-induced nephropathy (CIN), which is a well-described adverse event after angiography. CIN is a well-described adverse event following PCI, especially in high-risk patients, i.e., patients with an already deteriorating renal function or chronic kidney disease, as well as patients of advanced age or requiring an increased amount of contrast during their intervention. Among the techniques described for ULPCI procedures, intravascular imaging guidance seems a promising option, as it allows lesion recognition and characterization, stent implantation, and PCI optimization. Intravascular ultrasound (IVUS) is the modality most commonly used, as it does not require contrast injection, contrary to optical coherence tomography (OCT). Several clinical trials, assessing IVUS in the context of ULPCI, have shown that it can be safely used in this setting while offering a substantial reduction in contrast media volume, as well as renal adverse outcomes. This review aims to describe the need for ULPCI and technical considerations regarding the use of intravascular imaging in this setting, as well as analyze the available evidence from clinical trials regarding the safety and efficacy of IVUS-ULPCI, in order to provide a comprehensive summary for practicing physicians.
Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: rationale and design of the SPECTRUM study. [2022]Intravascular ultrasound (IVUS) improves clinical outcome in patients undergoing percutaneous coronary intervention (PCI) but dedicated prospective studies assessing the safety and efficacy of IVUS guidance during primary PCI are lacking.
Five multiresolution-based calcium volume measurement techniques from coronary IVUS videos: A comparative approach. [2017]Fast intravascular ultrasound (IVUS) video processing is required for calcium volume computation during the planning phase of percutaneous coronary interventional (PCI) procedures. Nonlinear multiresolution techniques are generally applied to improve the processing time by down-sampling the video frames.
A hybrid plaque characterization method using intravascular ultrasound images. [2016]Intravascular ultrasound (IVUS) is an invasive imaging modality that provides high resolution cross-sectional images permitting detailed evaluation of the lumen, outer vessel wall and plaque morphology and evaluation of its composition. Over the last years several methodologies have been proposed which allow automated processing of the IVUS data and reliable segmentation of the regions of interest or characterization of the type of the plaque.