A Prospective, Randomized Study of the Artegraft vs Propaten Vascular Grafts for Renal Failure Patients Requiring Dialysis Access
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft
研究概览
简要总结
Compare Artegraft and Propaten grafts for use in dialysis access to see if one performs better than the other. How long each one lasts until a complication arises or until the graft is no longer used will be compared.
The study hypothesis is that the Artegraft, being an actual blood vessel, will work better than the manufactured Propaten graft.
详细描述
Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care. Patients will be assessed at 2-3 weeks post-operatively and again at 6 and 12 months for flow characteristics, dialysis adequacy and graft associated complications such as stenosis, infection and thrombosis. Data on urea reduction ratio (URR), kinetic modeling (Kt/V), and access flow (QB) will be collected at 3, 6, 9 and 12 months via phone call to the hemodialysis center in order to evaluate patency and function.
Access complications (stenosis, thrombosis, infection) will be treated per our standard protocol. These data will be recorded and then primary, assisted primary and secondary patency rates will be calculated and the graft arms compared using life table analysis.
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
- 否
入选标准
- •> 18 years of age
- •Candidate for hemodialysis
- •Not a candidate for native AV fistula
- •In need of a new AV graft in the upper arm location
- •Artery and vein > 3mm.
- •Medically stable and have a life expectancy of ≥ 12 months
- •The patient or legal guardian understands the study and is willing to comply with the requirements.
排除标准
- •< 18 years of age
- •Current history or within 6 months of IV drug abuse
- •Chronic hypotension (<100 mm systolic pressure) not responsive to treatment
- •Pregnant or lactating
- •Known hypercoagulable state
- •Requires only a revision of an existing graft
- •Receiving artery or vein is less than 3 mm in diameter at the time of implantation
- •Known axillary/subclavian occlusion or stenosis that has not been treated
- •Known or suspected systemic infection
- •Heparin sensitivity (known HIT)
- •Enrolled in another investigational study.
- •Subject has more than 1 graft in target limb.
研究组 & 干预措施
Artegraft
Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
干预措施: Artegraft (Device)
Propaten
Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
干预措施: Propaten (Device)
结局指标
主要结局
Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft
时间窗: 12 months
The primary outcome will be determined by Kaplan-Meier life table analysis. Patency determination will be from access creation until the first occlusion of the graft.
次要结局
- Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft(12 months)