NCT03145662

High Pressure Balloon vs Cutting Balloon

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Toledo Health Science Campus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• End Stage Renal Failure on Dialysis

Interventions

Type	Name	Description
DEVICE	high pressure balloon	high pressure balloon will be used to treat stenosis
DEVICE	cutting balloon	cutting balloon will be used to treat stenosis

Timeline

• Start date: 2017-03-23
• Primary completion: 2019-03-23
• Completion: 2019-03-23
• First posted: 2017-05-09
• Last updated: 2024-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study