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Clinical Trials/NCT03145662
NCT03145662WithdrawnNot Applicable

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

University of Toledo Health Science Campus2 sites in 1 countryStarted: March 23, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
Stenosis Rate

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years of age
  • AV fistula or graft
  • Undergoing weekly hemodialysis
  • Patients must agree to the terms of the study and sign an informed Consent

Exclusion Criteria

  • 1. Pregnant women

Outcomes

Primary Outcomes

Stenosis Rate

Time Frame: 2 years

days of stenosis free period

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Toledo Health Science Campus
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Munier Nazzal, M.S. M.D

MD

University of Toledo Health Science Campus

Study Sites (2)

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