跳至主要内容
临床试验/NCT03145662
NCT03145662撤回不适用

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

University of Toledo Health Science Campus2 个研究点 分布在 1 个国家开始时间: 2017年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Stenosis Rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 1. Pregnant women

结局指标

主要结局

Stenosis Rate

时间窗: 2 years

days of stenosis free period

次要结局

未报告次要终点

研究者

发起方
University of Toledo Health Science Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Munier Nazzal, M.S. M.D

MD

University of Toledo Health Science Campus

研究点 (2)

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