Intravascular Ultrasound for Kidney Failure

(IVUS in ESRD Trial)

Overseen By Vipul Chitalia, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect central venous stenosis (CVS), a condition affecting individuals on hemodialysis for kidney failure. CVS occurs when dialysis catheters damage veins, potentially reducing dialysis effectiveness. Researchers compare intravascular ultrasound (IVUS), which uses sound waves to image veins, with the standard venography method. Suitable candidates for this trial have kidney failure, receive dialysis, and experience issues with their dialysis access at Boston Medical Center. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance dialysis care.

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 prior data suggests that intravascular ultrasound is safe for diagnosing central venous stenosis?

Research has shown that intravascular ultrasound (IVUS) is generally safe for patients. In several studies, procedures using IVUS proved effective and posed a low risk of harm. For example, one study found that using IVUS in patients with kidney disease was safe and did not lead to heart or kidney problems. Another study demonstrated that IVUS could be used safely without contrast dye, which is often used in imaging but can be risky for some patients. Overall, these findings suggest that IVUS is well-tolerated and safe for people with kidney-related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using intravascular ultrasound (IVUS) and venography for kidney failure because these techniques provide a detailed view inside blood vessels, which is not possible with standard imaging methods like CT scans or MRIs. Unlike traditional treatments that focus more on managing symptoms or dialysis, IVUS offers real-time, precise images that help doctors understand the condition of the blood vessels leading to the kidneys. This potentially allows for earlier intervention and better individualized treatment strategies, which could significantly improve patient outcomes. Moreover, the use of image processing alongside IVUS helps in enhancing the accuracy of the diagnosis and treatment planning.

What evidence suggests that intravascular ultrasound is effective for central venous stenosis?

Studies have shown that intravascular ultrasound (IVUS) greatly aids in guiding treatments inside blood vessels. Compared to venography, IVUS provides clearer images, leading to better treatment decisions. This is particularly beneficial for patients with kidney problems, as IVUS uses little to no contrast dye, which can harm the kidneys. Research indicates that IVUS can be effective without causing additional issues for the heart or kidneys. In this trial, participants in the IVUS and venography group will receive both IVUS and venography, along with image processing, to identify vein problems like central venous stenosis (CVS) in patients undergoing hemodialysis. ^{1 2 3 6 7}

Who Is on the Research Team?

Vipul Chitalia, MD PhD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

N/A

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Image processing
• Intravascular ultrasound (IVUS)
• Venography

Trial Overview 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.

How Is the Trial Designed?

Group I: IVUS and venography group Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The study evaluated 20 combinations of segmentation methods and multiresolution techniques for calcium volume measurement in IVUS images, using data from 19 patients and 38,760 frames, and found that Fuzzy c-Means (FCM) with wavelet-based multiresolution provided the best performance, improving computational time by over 77%.

The proposed system not only enhanced the speed of calcium volume computation but also included a bias correction approach that improved the accuracy of volume measurements, making it suitable for clinical applications without compromising image quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five multiresolution-based calcium volume measurement techniques from coronary IVUS videos: A comparative approach. Banchhor, SK., Araki, T., Londhe, ND., et al.[2017]

A novel automated methodology for analyzing grayscale intravascular ultrasound (IVUS) images can accurately classify plaque components into three categories: Hard Calcified, Hard-Non Calcified, and Soft plaque, achieving an overall classification accuracy of 86.14%.

This method combines image processing techniques with a Random Forest classifier, making it a reliable tool for assessing plaque composition, which is important for both clinical evaluations and research in cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hybrid plaque characterization method using intravascular ultrasound images. Athanasiou, LS., Karvelis, PS., Sakellarios, AI., et al.[2016]

The SPECTRUM study is a prospective observational study involving 200 patients with ST-segment elevation myocardial infarction, aiming to assess the safety and efficacy of intravascular ultrasound (IVUS) guidance during primary percutaneous coronary intervention (PCI).

The primary endpoint is to evaluate target vessel failure at 12 months, which includes cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization, providing important insights into the long-term outcomes of IVUS-guided PCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: rationale and design of the SPECTRUM study. Groenland, FTW., Mahmoud, KD., Neleman, T., et al.[2022]

Intravascular ultrasound (IVUS) significantly improves the 12-month primary patency rate (70% to 90%) and freedom from clinically driven target lesion revascularization (cdTLR) rate (83.9% to 94.7%) compared to conventional angiography alone, based on a review of 4 studies involving 1160 patients.

The pooled analysis indicates that IVUS-guided endovascular treatment offers better clinical outcomes, suggesting it could be a valuable tool for clinicians in treating femoropopliteal artery lesions, although more high-quality studies are needed to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravascular Ultrasound-Guided Versus Angiography-Guided Endovascular Therapy for Femoropopliteal Artery Disease: A Scoping Review. Meng, W., Guo, J., Pan, D., et al.[2023]

In a study of 49 human specimens, intravascular ultrasound (IVUS) demonstrated a sensitivity of 70% for detecting calcified lesions in the abdominal aorta and iliac artery, indicating it can effectively identify these lesions.

However, the specificity of IVUS was only 53%, suggesting that it may produce a significant number of false positives, which limits its reliability in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro correlation of intravascular ultrasound and direct magnification radiography for calcified arterial lesions. Link, TM., Kerber, S., Pöppelmann, M., et al.[2019]

The new automated segmentation method for intravascular ultrasound (IVUS) accurately detects the lumen and external vessel wall boundaries in femoral arteries, showing high agreement with expert manual tracings across 20 in vivo data sets.

This method significantly reduces the need for manual intervention and speeds up the analysis process while maintaining high accuracy, with average contour distances of less than 0.13 mm compared to expert tracings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast-marching segmentation of three-dimensional intravascular ultrasound images: a pre- and post-intervention study. Cardinal, MH., Soulez, G., Tardif, JC., et al.[2017]

Intravascular ultrasound (IVUS) has evolved from primarily imaging atherosclerosis to being a versatile tool for guiding various interventions in both the arterial and venous systems, enhancing procedural safety.

The use of IVUS can reduce the need for fluoroscopy during procedures, which not only minimizes radiation exposure but also supports the development of new medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravascular ultrasound for transvenous interventions. Thakrar, PD., Petersen, BD., Kaufman, JA.[2016]

Intravascular ultrasound (IVUS) imaging can reveal hyperechoic areas in renal arteries, which may indicate the presence of atherosclerosis, based on evaluations of both post-mortem and in vivo studies involving 18 human renal arteries and 5 patients.

However, the typical three-layered appearance seen in vitro does not always match in vivo results, highlighting the need for caution when interpreting IVUS findings from laboratory studies in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravascular ultrasound imaging of atherosclerotic renal arteries: comparison between in vitro and in vivo studies. Yasuda, G., Takizawa, T., Takasaki, I., et al.[2019]

In a study of 30 patients, intravascular ultrasound (IVUS) was successfully used to evaluate the inferior vena cava (IVC) prior to filter placement, demonstrating its safety and efficacy as an alternative to traditional positive-contrast vena cavography.

IVUS effectively assessed the IVC's patency and anatomy without complications, making it particularly beneficial for patients with contraindications to iodinated contrast or radiation exposure, such as those with renal insufficiency or pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravascular ultrasound as an alternative to positive-contrast vena cavography prior to filter placement. Bonn, J., Liu, JB., Eschelman, DJ., et al.[2019]

Ultra-low contrast percutaneous coronary interventions (ULPCIs) aim to minimize the risk of contrast-induced nephropathy (CIN), particularly in high-risk patients such as those with chronic kidney disease or advanced age.

Intravascular ultrasound (IVUS) has been shown to be a safe and effective imaging technique for ULPCI, significantly reducing the volume of contrast media used and improving renal outcomes based on clinical trial evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravascular Imaging in Ultra-Low or Zero-Contrast Percutaneous Coronary Interventions: The Time Is Now? Dimitriadis, K., Pyrpyris, N., Papanikolaou, A., et al.[2023]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacasi.2024.11.005

Outcomes of Intracoronary Imaging-Guided PCI in Patients ... IC imaging guidance was associated with a reduced risk of cardiac death, target lesion revascularization, and stent thrombosis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8125490/

Safety and Efficacy of Minimum- or Zero-Contrast IVUS– ... Contrast-free and IVUS-guided PCI procedures in patients with CKD appear to be safe (both in cardiac and renal outcomes) with a comparable efficacy to the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509624003066

Role and Value of Intravascular Ultrasound in the End- ... In recent years, the use of intravascular ultrasound (IVUS) has been shown to positively affect treatment decision-making in comparison to venography in lower ...

4. ahajournals.org ahajournals.org/doi/full/10.1161/CIRCINTERVENTIONS.124.014854?doi=10.1161/CIRCINTERVENTIONS.124.014854

Ultra-Low Contrast IVUS-Guided PCI in Patients With ... In this observational, prospective, multicenter study, ultra-low contrast IVUS-guided PCI appears to be effective and safe in patients with ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2812357

Intravascular Imaging in Patients With Complex Coronary ... In addition, IVUS (not OCT) can suppress kidney function deterioration by minimizing contrast volume during PCI in patients with CKD, as has ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527322001243

Safety and feasibility of intravascular ultrasound guided ... This prospective study shows that zero-contrast PCI is safe and feasible in selective coronary anatomies. IVUS guidance alone is sufficient.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34066543/

or Zero-Contrast IVUS-Guided Percutaneous Coronary ... Given the literature reported so far, contrast-free and IVUS-guided PCI procedures in patients with CKD appear to be safe (both in cardiac and ...