High Pressure Balloon vs Cutting Balloon
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | March 23, 2017 |
| End Date: | March 23, 2019 |
| Contact: | Munier Nazzal, MD |
| Email: | munier.nazzal@utoledo.edu |
| Phone: | 419-383-6810 |
Cutting Balloon vs. High Pressure Balloon for the Treatment of AV Graft Stenosis
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.
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.
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.
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
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