End Stage Renal DiseaseIVUS in ESRDNCT04399941
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
A study testing Venography, Intravascular ultrasound (IVUS) and Image processing in people with End Stage Renal Disease, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Venography, Intravascular ultrasound (IVUS) and Image processing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2021to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
James Decker contact
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Vipul Chitalia, MD PhD, vipul.chitalia@bmc.org
James Decker, jdecker@bu.edu
About this study
Official title: Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
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.
- Conditions
- End Stage Renal Disease
- Being tested
- Venography, Intravascular ultrasound (IVUS), Image processing
- Keywords
- intravenous ultrasound (IVUS), central venous stenosis (CVS), hemodialysis, dialysis access malfunction, fistulogram, stenosis, virtual histology (VH-IVUS) software
- Medical subject headings
- Kidney Failure, Chronic, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenographyDiagnostic test
Also called Fistulogram
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.
Intravascular ultrasound (IVUS)Diagnostic test
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.
Image processingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| IVUS and venography group | Experimental | Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing. Receives: Diagnostic Test: Venography; Diagnostic Test: Intravascular ultrasound (IVUS); Other: Image processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
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.
Measured: 18 months
Morphology of lesion
The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start3 Aug 2021
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vipul Chitalia, MD PhD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399941
- Sponsor's protocol ID
- H-37396
- Other IDs
- 1R21DK119740-01A1
- Acronym
- IVUS in ESRD
- Status last verified
- Sep 2026
- First submitted
- 19 May 2020
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
- ClinicalTrials.gov ID
- NCT04399941
- Acronym / sponsor ID
- IVUS in ESRD / H-37396
- Conditions
- End Stage Renal Disease
- Keywords
- intravenous ultrasound (IVUS), central venous stenosis (CVS), hemodialysis, dialysis access malfunction, fistulogram, stenosis, virtual histology (VH-IVUS) software
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVUS and venography group | Experimental | Diagnostic Test: Venography, Diagnostic Test: Intravascular ultrasound (IVUS), Other: Image processingParticipants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenographyAlso: FistulogramThe 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. | Diagnostic test | IVUS and venography group |
| 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. | Diagnostic test | IVUS and venography group |
| Image processingImage 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. | Other | IVUS and venography group |
Primary outcome
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.
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.
Morphology of lesion
Time frame: 18 months
The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Decker contact
Vipul Chitalia, MD PhD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venography, Intravascular ultrasound (IVUS) and Image processing in people with End Stage Renal Disease, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vipul Chitalia, MD PhD (617 638 7330, vipul.chitalia@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of stenosis (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.