NCT07034092尚未招募不适用
Feasibility Study to Evaluate the Safety and Efficacy of the ePATH System for endoAVF Creation
Pathfinder Medical2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Patients deemed eligible for creation of an AV fistula according to institutional or local guidelines and/or clinical judgement of the investigator
- •Adults (age >18 years old)
- •Non-reversible kidney failure requiring hemodialysis (this can include pre-dialysis patients)
- •Target vein diameter of ≥2.0 mm
- •Target artery diameter of ≥2.0 mm
- •Both radial and ulnar artery flow to the hand, confirmed with Duplex Ultrasound and/or Allen's test (i.e. palmar arch)
- •Able to provide informed consent
- •Able to comply with follow-up visit assessment requirements
- •Patient is free from clinically significant conditions or illnesses that might compromise the procedure or the AVF
排除标准
- •Significant central venous stenosis or narrowing that exceeds 50% based on imaging
- •Hypercoagulable state or known bleeding diathesis
- •NHYA Class III or IV heart failure
- •Estimated life-expectancy of <1 year based on the physician's opinion
- •Oedema of extremities
- •Current diagnosis of carcinoma
- •Pregnant or breastfeeding women
- •Diagnosed or suspected skin disease at the access site
- •Immunosuppression or otherwise immunocompromised patients
- •Currently being treated with another investigational device or medication
- •Allergy to contrast or other drugs associated with surgery, e.g., sedation agents, or to device materials
- •Anatomy that prevents formation of AVF, e.g., misalignment of vessels or tortuosity
- •Patient is unwilling to undergo 2nd stage procedure, e.g. endovascular prothesis placement or balloon dilatation, if required
结局指标
主要结局
Primary Safety Endpoint
时间窗: 3 months
Proportion of patients that experience one or more serious ePATH device-related or ePATH portion of the procedure-related adverse events during the first 3 months following AVF creation.
次要结局
- Technical Success(7 days)
- AVF maturation(3 months)
- Time to fistula maturation(3 months)
- Rate of other device or other procedure-related adverse events(3 months)
- Rate of device and/or procedure related infections(3 months)
研究者
研究点 (2)
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