High Pressure Balloon vs Cutting Balloon

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cutting Balloon vs. High Pressure Balloon for the Treatment of AV Graft Stenosis

Conditions
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End Stage Renal Failure on Dialysis

Intervention / Treatment
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* Device: high pressure balloon
* Device: cutting balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1. Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomization to either high pressure balloon or cutting balloon
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high pressure balloon<br>randomized to have dialysis fistula or AV graft treated with high pressure balloon | Device: high pressure balloon<br>* high pressure balloon will be used to treat stenosis<br>|
| Active Comparator: cutting balloon<br>randomized to have dialysis fistula or AV graft treated with cutting balloon | Device: cutting balloon<br>* cutting balloon will be used to treat stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stenosis Rate | days of stenosis free period | 2 years |