NCT05880537招募中不适用
Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- UltraSound evaluation of allograft functional patency.
研究概览
简要总结
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
详细描述
The clinical objective of this prospective, observational, post market registry study, CR-21-005, is to assess the safety and efficacy of a decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery, LifeNet Health, Virginia Beach, VA) in the creation of vascular access for hemodialysis in patients with ESRD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Be male or female, ≥18 years of age at the time of graft placement
- •Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis
- •Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option.
- •Have the ability themselves, or through their legal guardian, to understand the requirements of the study, to provide written informed consent/assent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and to agree to abide by the study restrictions and return to the site for the required assessments
- •Have provided written authorization for use and disclosure of protected health information
排除标准
- •Be participating in a study of another investigational drug or device
- •Have a known sensitivity to any of the processing reagents utilized in the manufacture of this product such as antibiotics (Lincomycin, Polymyxin B, Ciprofloxacin, Meropenum, Gentamicin, or Vancomycin) and processing reagents (N-lauroyl sarcosine, Denarase and glycerol/glycerin)
- •Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment
- •Have a history or evidence of severe peripheral vascular disease in the upper extremities
- •Have the inability or be unable or unwilling to follow the study visit schedule
- •Have the presence of any condition that, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated
研究组 & 干预措施
Open Label
Open Label for subjects with End-Stage Renal Disease
干预措施: Nexeon Arterial Venous Allograft (Other)
结局指标
主要结局
UltraSound evaluation of allograft functional patency.
时间窗: 24 months
Ultrasound proof of vessel patency and blood flow
次要结局
- Secondary Endpoint:(24 months)
研究者
研究点 (8)
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