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High Pressure Balloon vs Cutting Balloon

Primary Purpose

End Stage Renal Failure on Dialysis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high pressure balloon
cutting balloon
Sponsored by
University of Toledo Health Science Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Failure on Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UTMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

high pressure balloon

cutting balloon

Arm Description

randomized to have dialysis fistula or AV graft treated with high pressure balloon

randomized to have dialysis fistula or AV graft treated with cutting balloon

Outcomes

Primary Outcome Measures

Stenosis Rate
days of stenosis free period

Secondary Outcome Measures

Full Information

First Posted
March 24, 2017
Last Updated
March 6, 2019
Sponsor
University of Toledo Health Science Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03145662
Brief Title
High Pressure Balloon vs Cutting Balloon
Official Title
Cutting Balloon vs. High Pressure Balloon for the Treatment of AV Graft Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2017 (Actual)
Primary Completion Date
March 23, 2019 (Anticipated)
Study Completion Date
March 23, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure on Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomization to either high pressure balloon or cutting balloon
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high pressure balloon
Arm Type
Active Comparator
Arm Description
randomized to have dialysis fistula or AV graft treated with high pressure balloon
Arm Title
cutting balloon
Arm Type
Active Comparator
Arm Description
randomized to have dialysis fistula or AV graft treated with cutting balloon
Intervention Type
Device
Intervention Name(s)
high pressure balloon
Intervention Description
high pressure balloon will be used to treat stenosis
Intervention Type
Device
Intervention Name(s)
cutting balloon
Intervention Description
cutting balloon will be used to treat stenosis
Primary Outcome Measure Information:
Title
Stenosis Rate
Description
days of stenosis free period
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Munier Nazzal, MD
Phone
419-383-6810
Email
munier.nazzal@utoledo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Munier Nazzal, MD
Phone
4193835150
Email
munier.nazzal@utoledo.edu
Facility Information:
Facility Name
UTMC
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Munier Nazzal, MD
Phone
419-383-6810
Email
munier.nazzal@utoledo.edu
First Name & Middle Initial & Last Name & Degree
Munier Nazzal, MD
Phone
4193835150
Email
munier.nazzal@utoledo.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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High Pressure Balloon vs Cutting Balloon

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