Cutting Balloon vs. High Pressure Balloon for the Treatment of AV Graft Stenosis
| Registry | NCT03145662 |
|---|---|
| Status | Withdrawn - Lack of Resources |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Sponsor | University of Toledo Health Science Campus (Other) |
| Conditions | End Stage Renal Failure on Dialysis |
| Interventions | high pressure balloon, cutting balloon (Device) |
| Dates | start 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 in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for End Stage Renal Failure on Dialysis All trials of high pressure balloon All trials of cutting balloon
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| high pressure balloon | Active comparator | Device: high pressure balloon | randomized to have dialysis fistula or AV graft treated with high pressure balloon |
| cutting balloon | Active comparator | Device: cutting balloon | randomized to have dialysis fistula or AV graft treated with cutting balloon |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| UTMC | Toledo, Ohio | United States |