Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis (IVUS in ESRD)
Primary Purpose
End Stage Renal Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venography
Intravascular ultrasound (IVUS)
Image processing
Sponsored by
About this trial
This is an interventional diagnostic trial for End Stage Renal Disease focused on measuring intravenous ultrasound (IVUS), central venous stenosis (CVS), hemodialysis, dialysis access malfunction, fistulogram, stenosis, virtual histology (VH-IVUS) software
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:
- None
Sites / Locations
- Boston Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IVUS and venography group
Arm Description
Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.
Outcomes
Primary Outcome Measures
Extent of stenosis
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
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.
Morphology of lesion
The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.
Secondary Outcome Measures
Full Information
NCT ID
NCT04399941
First Posted
May 19, 2020
Last Updated
July 30, 2023
Sponsor
Boston Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04399941
Brief Title
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
Acronym
IVUS in ESRD
Official Title
Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
intravenous ultrasound (IVUS), central venous stenosis (CVS), hemodialysis, dialysis access malfunction, fistulogram, stenosis, virtual histology (VH-IVUS) software
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IVUS and venography group
Arm Type
Experimental
Arm Description
Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.
Intervention Type
Diagnostic Test
Intervention Name(s)
Venography
Other Intervention Name(s)
Fistulogram
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Intravascular ultrasound (IVUS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Image processing
Intervention Description
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 Measure Information:
Title
Extent of stenosis
Description
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.
Time Frame
18 months
Title
Length of lesions
Description
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.
Time Frame
18 months
Title
Morphology of lesion
Description
The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vipul Chitalia, MD PhD
Phone
617 638 7330
Email
vipul.chitalia@bmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vipul Chitalia, MD PhD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vipul Chitalia, MD PhD
Email
vipul.chitalia@bmc.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
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