Study Stopped
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High Pressure Balloon vs Cutting Balloon
Cutting Balloon vs. High Pressure Balloon for the Treatment of AV Graft Stenosis
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2017
CompletedFirst Submitted
Initial submission to the registry
March 24, 2017
CompletedFirst Posted
Study publicly available on registry
May 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2019
CompletedJune 6, 2024
June 1, 2024
2 years
March 24, 2017
June 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Stenosis Rate
days of stenosis free period
2 years
Study Arms (2)
high pressure balloon
ACTIVE COMPARATORrandomized to have dialysis fistula or AV graft treated with high pressure balloon
cutting balloon
ACTIVE COMPARATORrandomized to have dialysis fistula or AV graft treated with cutting balloon
Interventions
high pressure balloon will be used to treat stenosis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \. Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UTMC
Toledo, Ohio, 43614, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 24, 2017
First Posted
May 9, 2017
Study Start
March 23, 2017
Primary Completion
March 23, 2019
Study Completion
March 23, 2019
Last Updated
June 6, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share