Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2017-03-23
2019-03-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Drug-coated Balloon Versus Conventional Balloon Angioplasty in Hemodialysis Graft
NCT02706444
Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis
NCT04627051
Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
NCT06503692
DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis
NCT06527963
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis (Dialysis Fistulae)
NCT03036241
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
high pressure balloon
randomized to have dialysis fistula or AV graft treated with high pressure balloon
high pressure balloon
high pressure balloon will be used to treat stenosis
cutting balloon
randomized to have dialysis fistula or AV graft treated with cutting balloon
cutting balloon
cutting balloon will be used to treat stenosis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
high pressure balloon
high pressure balloon will be used to treat stenosis
cutting balloon
cutting balloon will be used to treat stenosis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Toledo Health Science Campus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Munier Nazzal, M.S. M.D
MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UTMC
Toledo, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HPB vs CB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.