NCT00131872终止2 期
Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 172
- 试验地点
- 16
- 主要终点
- Primary or assisted primary patency at 1 year
研究概览
简要总结
The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient has chronic renal failure and requires vascular access for hemodialysis
- •Patient has given informed consent to participate in the trial and is willing to comply with the study protocol
- •Patient is male or female, 18 years of age or older
- •The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm)
- •Patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center
- •Patient has a vein 4 mm or larger to which the graft can be anastomosed
排除标准
- •Patient is unable to comply with the study follow-up
- •Patient has a known sensitivity to polyurethane or porcine heparin
- •Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available
- •Patient has an immunodeficiency syndrome
- •Patient has a prior history of bacterial infection within 8 weeks of implantation of graft
- •Patient has a severe coagulation disorder
- •Patient has an elevated platelet count of greater than 1 million
- •Patient has a history of heparin-induced thrombocytopenia syndrome (HIT)
- •Patient is pregnant
- •Patient has a fever greater than 100 degrees Fahrenheit
结局指标
主要结局
Primary or assisted primary patency at 1 year
次要结局
- Overall adverse event rate
- Time to first access
- Time to hemostasis following needle withdrawal after dialysis
- Secondary patency
研究者
研究点 (16)
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