Other Clinical Trial - High Pressure Balloon vs Cutting Balloon

Status Recruiting

Clinical Trial Summary

Clinical Trial 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 Design

Related Conditions & MeSH terms

End Stage Renal Failure on Dialysis
Kidney Failure, Chronic
Renal Insufficiency

Clinical Trial Details

NCT number	NCT03145662
Study type	Interventional
Source	University of Toledo Health Science Campus
Contact	Munier Nazzal, MD
Phone	419-383-6810
Email	munier.nazzal@utoledo.edu
Status	Recruiting
Phase	N/A
Start date	March 23, 2017
Completion date	March 23, 2019

View Details

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