End Stage Renal Failure on DialysisNCT03145662
High Pressure Balloon vs Cutting Balloon
A study testing high pressure balloon and cutting balloon in people with End Stage Renal Failure on Dialysis, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- high pressure balloon and cutting balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2017to 23 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years of age
- AV fistula or graft
- Undergoing weekly hemodialysis
- Patients must agree to the terms of the study and sign an informed Consent
Who cannot join
- 1. Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cutting Balloon vs. High Pressure Balloon for the Treatment of AV Graft Stenosis
Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). Angiograms will then be performed before and after intervention.
Read the detailed description
Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). Angiograms will then be performed before and after intervention.
Data will be collected from standard of care visit, including physician visits and ultrasounds. Follow up will be based on the function of the AV access, dialysis center criteria and/or standard of care ultrasound results: including venous pressure of the AV access, difficult cannulation, urea recirculation, and change in character and sound of the AV access (thrill/bruit), which are standard of care assessment at a dialysis center. All patient data sheets will be kept in a study binder and locked in the research room. Randomization will be performed with a computer program.
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- high pressure balloon, cutting balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high pressure balloonDevice
high pressure balloon will be used to treat stenosis
cutting balloonDevice
cutting balloon will be used to treat stenosis
| Study group | Role | What they receive |
|---|---|---|
| high pressure balloon | Active comparator | randomized to have dialysis fistula or AV graft treated with high pressure balloon Receives: Device: high pressure balloon |
| cutting balloon | Active comparator | randomized to have dialysis fistula or AV graft treated with cutting balloon Receives: Device: cutting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stenosis Rate
days of stenosis free period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start23 Mar 2017
- Primary completion23 Mar 2019
- Study completion23 Mar 2019
Why it stopped: Lack of Resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomization to either high pressure balloon or cutting balloon
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munier Nazzal, M.S. M.D, University of Toledo Health Science Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145662
- Sponsor's protocol ID
- HPB vs CB
- Status last verified
- Jun 2024
- First submitted
- 24 Mar 2017
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutting Balloon vs. High Pressure Balloon for the Treatment of AV Graft Stenosis
- ClinicalTrials.gov ID
- NCT03145662
- Acronym / sponsor ID
- HPB vs CB
- Conditions
- End Stage Renal Failure on Dialysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 23 Mar 2019 (actual)
- Study completion
- 23 Mar 2019 (actual)
- First posted
- 9 May 2017 (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.
Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). Angiograms will then be performed before and after intervention.
Detailed description
Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). Angiograms will then be performed before and after intervention.
Data will be collected from standard of care visit, including physician visits and ultrasounds. Follow up will be based on the function of the AV access, dialysis center criteria and/or standard of care ultrasound results: including venous pressure of the AV access, difficult cannulation, urea recirculation, and change in character and sound of the AV access (thrill/bruit), which are standard of care assessment at a dialysis center. All patient data sheets will be kept in a study binder and locked in the research room. Randomization will be performed with a computer program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomization to either high pressure balloon or cutting balloon
| Arm | Type | Receives |
|---|---|---|
| high pressure balloon | Active comparator | Device: high pressure balloonrandomized to have dialysis fistula or AV graft treated with high pressure balloon |
| cutting balloon | Active comparator | Device: cutting balloonrandomized to have dialysis fistula or AV graft treated with cutting balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years of age
- AV fistula or graft
- Undergoing weekly hemodialysis
- Patients must agree to the terms of the study and sign an informed Consent
Key exclusion criteria (1 listed)
- 1. Pregnant women
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 |
|---|---|---|
| high pressure balloonhigh pressure balloon will be used to treat stenosis | Device | high pressure balloon |
| cutting ballooncutting balloon will be used to treat stenosis | Device | cutting balloon |
Primary outcome
Stenosis Rate
Time frame: 2 years
days of stenosis free period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high pressure balloon and cutting balloon in people with End Stage Renal Failure on Dialysis, run by University of Toledo Health Science Campus 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: withdrawn, as of the sponsor's last update on 6 Jun 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stenosis Rate (time frame: 2 years). 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 6 Jun 2024.