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Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis (IVUS in ESRD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399941
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Diagnostic Test: Venography Diagnostic Test: Intravascular ultrasound (IVUS) Other: Image processing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IVUS and venography group
Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.
Diagnostic Test: 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.
Other Name: Fistulogram

Diagnostic Test: 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.

Other: 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 Measures :
  1. 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.

  2. 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.

  3. Morphology of lesion [ Time Frame: 18 months ]
    The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399941


Contacts
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Contact: Vipul Chitalia, MD PhD 617 638 7330 vipul.chitalia@bmc.org

Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Contact: Vipul Chitalia, MD PhD       vipul.chitalia@bmc.org   
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Vipul Chitalia, MD PhD Boston Medical Center
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT04399941    
Other Study ID Numbers: H-37396
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Boston Medical Center:
intravenous ultrasound (IVUS)
central venous stenosis (CVS)
hemodialysis
dialysis access malfunction
fistulogram
stenosis
virtual histology (VH-IVUS) software
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency