NCT02682420终止不适用
everlinQ endoAVF Post Market Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- C. R. Bard
- 入组人数
- 100
- 试验地点
- 21
- 主要终点
- Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure
研究概览
简要总结
Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.
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
- •Adult (age >18 years old)
- •Currently on chronic dialysis or expected to be started on chronic dialysis within 3 months of planned endoAVF creation
- •Target treatment vein diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Venogram
- •Target treatment artery diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Arteriogram
- •Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound and/or Allen's test (i.e.: palmar arch)
排除标准
- •Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation
- •Absence of perforator feeding the target cannulation vein(s) via Venogram
- •Occlusion or stenosis >50% of target cannulation cephalic or basilic vein
- •Significantly compromised (≥50% stenosis) flow in the treatment arm
- •Documented ejection fraction (EF) ≤35% in the last 6 months
- •Pregnant women
- •New York Heart Association (NYHA) class III or IV heart failure
- •Hypercoagulable state
- •Known bleeding diathesis
- •Documented history of drug abuse including intravenous drugs within six months of AVF creation
- •"Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment
- •Known allergy to contrast dye which cannot be adequately pre-medicated
- •Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
- •Evidence of active infections on the day of the index procedure
- •Estimated life expectancy < 1 year
- •Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up
- •Patient with a target cannulation vein that is > 6mm deep that would require a transposition procedure, defined as the elevation of a target cannulation vein AND the creation of a new AV fistula
- •Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of the study protocol.
结局指标
主要结局
Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure
时间窗: endoAVF creation through 6 months
Primary patency was defined in this study as "The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency".
次要结局
未报告次要终点
研究者
研究点 (21)
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