High Pressure Balloon vs Cutting Balloon

Not Applicable

Withdrawn

• Conditions: End Stage Renal Failure on Dialysis
• Interventions: Device: cutting balloon; Device: high pressure balloon

• Registration Number: NCT03145662
• Lead Sponsor: University of Toledo Health Science Campus

Brief 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.

Study Timeline

• Study Start: 2017-03-23
• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-09
• Primary Completion: 2019-03-23
• Study Completion: 2019-03-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cutting balloon	cutting balloon	randomized to have dialysis fistula or AV graft treated with cutting balloon
high pressure balloon	high pressure balloon	randomized to have dialysis fistula or AV graft treated with high pressure balloon

Primary Outcome Measures

Name	Time	Method
Stenosis Rate	2 years	days of stenosis free period

Trial Locations

Locations (1)

UTMC; 🇺🇸 Toledo, Ohio, United States