High Pressure Balloon vs Cutting Balloon

University of Toledo Health Science Campus

Status: Withdrawn

Conditions: End Stage Renal Failure on Dialysis

Treatments: Device: high pressure balloon; Device: cutting balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT03145662

HPB vs CB

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years of age
2. AV fistula or graft
3. Undergoing weekly hemodialysis
4. Patients must agree to the terms of the study and sign an informed Consent

Exclusion criteria

1. Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

high pressure balloon

Active Comparator group

Description:

randomized to have dialysis fistula or AV graft treated with high pressure balloon

Treatment:

Device: high pressure balloon

cutting balloon

Active Comparator group

Description:

randomized to have dialysis fistula or AV graft treated with cutting balloon

Treatment:

Device: cutting balloon