A Comparison Between the HeRO® Graft and Conventional Arteriovenous Grafts in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 22
- 主要终点
- Percentage of Patients With Primary Patency
研究概览
简要总结
Compare the HeRO Vascular Access Device to a conventional ePTFE graft.
详细描述
The purpose of this study is to compare the HeRO Vascular Access Device to a conventional ePTFE graft. It is hypothesized that HeRO patency will be comparable to the conventional ePTFE graft control.
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
- 22 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 years of age or older.
- •Male or non-pregnant female.
- •Life expectancy 2 years.
- •End-stage renal disease requiring an arm vascular prosthesis for dialysis access.
- •Ability to understand and provide written informed consent.
- •Willing and able to cooperate with follow-up examinations.
- •Subject's upper arm can be used for implant (Note: The GVAS device must be implanted in the upper arm only, but the Control group graft can be implanted in the upper or lower arm location.).
- •Able to follow a daily aspirin and/or other oral anticoagulation/antiplatelet regimen.
排除标准
- •Potential graft target artery less than 3 mm in diameter determined by any suitable preoperative measure.
- •Documented history of drug abuse within six months.
- •"Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.
- •Currently being treated with another investigational device or drug.
- •Known bleeding diathesis or hypercoagulable state.
- •Peripheral white blood cell count 1500/mm3 (1.5 K/mm3) or platelet counts 50,000/mm3 (50 K/mm3).
- •Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be included.
- •Subjects with known or suspected concomitant bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B may be included. Subjects who are HIV + with CD4 count of <200 are excluded.
- •Severe underlying co-morbidity or immediate life-threatening condition.
- •Subjects with any condition which, in the opinion of the investigator, could preclude evaluation of response or completion of follow-up or affect subject safety.
- •Subjects who are candidates for autologous fistulas.
- •Subjects with scheduled renal transplant within the next 12 months.
结局指标
主要结局
Percentage of Patients With Primary Patency
时间窗: 6 months, 12 months
Primary patency was defined as the interval of time from access placement until any intervention designed to maintain or reestablish patency, access thrombosis, or the time of measurement of patency.
Percentage of Patients With Assisted Primary Patency
时间窗: 6 months, 12 months
Assisted primary patency was defined as the interval of time from access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (i.e., surgical or endovascular interventions) designed to maintain the functionality of a patent access.
Percentage of Patients With Secondary Patency
时间窗: 12 months
Secondary patency was defined as the interval of time from access placement until access abandonment, thrombosis, or the time of patency measurements including intervening surgical or endovascular interventions designed to reestablish functionality in a thrombosed access.
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
时间窗: 12 months
Serious adverse events were defined as events that required hospitalization ≥24 hours, prolonged an existing hospitalization, resulted in persistent or significant disability or incapacity, were considered life-threatening, or resulted in death.
次要结局
- Adequacy of Dialysis(12 months)