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High Pressure Balloon vs Cutting Balloon

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03145662
Enrollment
0
Registered
2017-05-09
Start date
2017-03-23
Completion date
2019-03-23
Last updated
2024-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Failure on Dialysis

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.

Interventions

DEVICEhigh pressure balloon

high pressure balloon will be used to treat stenosis

cutting balloon will be used to treat stenosis

Sponsors

University of Toledo Health Science Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

randomization to either high pressure balloon or cutting balloon

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stenosis Rate2 yearsdays of stenosis free period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026