NCT05462223Unknown不适用
A Study of the Safety and Feasibility of the Vessel Restoration System for AVF to Promote the Physiologic and Functional Maturation of Upper-extremity Autologous End-to-Side Arteriovenous Fistulas (AVF) in Patients With Chronic Kidney Disease: ACTIVATE AVF
Alucent Biomedical21 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2022年7月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 21
- 主要终点
- AVF Maturation
研究概览
简要总结
Feasibility of the Vessel Restoration System for AVF
详细描述
A study of the safety and feasibility of the Vessel Restoration System for AVF to promote the physiologic and functional maturation of a Brachiocephalic End-to-Side Arteriovenous Fistulas (AVF) in Patients with Chronic Kidney Disease Stage V (Pre-dialysis): ACTIVATE AVF
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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 and can provide informed consent
- •Use birth control
- •Chronic Kidney Disease
排除标准
- •Receiving hemodialysis
- •Pregnant, breastfeeding, planning to become pregnant
- •Receiving immunosuppressants
- •Has "Long COVID"
研究组 & 干预措施
Alucent VRS for Treatment of Atherosclerotic Lesions
Experimental
Alucent Vessel Restoration System for AVF (VRS-AVF) consists of the following components:
- VRS 10-8-10 Dimer Coated Balloon Catheter for AVF
- VRS Light Fiber
- VRS Light Source
干预措施: Alucent Vessel Restoration System for AVF (Combination Product)
结局指标
主要结局
AVF Maturation
时间窗: 2 weeks to 3 months
Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points
次要结局
未报告次要终点
研究者
研究点 (21)
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