everlinQ Endovascular Access Systems Enhancements (EASE-2) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- C. R. Bard
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of Participants With Procedural Success
研究概览
简要总结
Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients. This study aims to investigate expansion of the percutaneous venous access location to the superficial system which may provide additional procedural benefit.
详细描述
A total of up to 50 subjects will be enrolled and will undergo an endoAVF creation procedure using the everlinQ System. All subjects may be followed for up to 12 months post index procedure based on Investigator's discretion. The duration of the study is expected to be approximately two (2) years.
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
- •Eligible for a native arteriovenous fistula.
- •Adult (age >18 years old).
- •Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients).
- •Target vein diameter(s) at fistula site ≥ 2.0 mm.
- •Target artery diameter at fistula site ≥ 2.0 mm.
- •Procedural access site artery and vein diameter ≥ 2.0 mm.
- •At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein.
- •Estimated life expectancy > 1 year.
- •Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure.
- •Presence of an antecubital perforating vein diameter ≥ 2.0 mm.
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.
- •Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by the everlinQ System as deemed by the interventionalists' clinical judgment.
- •Prior surgically created access in the planned treatment location.
- •Functioning surgical access in the planned treatment arm.
- •Pregnant women.
- •New York Heart Association (NYHA) class III or IV heart failure.
- •Hypercoagulable state.
- •Known bleeding diathesis.
- •Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition.
- •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.
- •Currently being treated with another investigational device or drug.
- •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.
- •Patients who do not have an ulnar or radial artery.
- •Distance between target artery and vein or other anatomical abnormality will not permit catheters to be introduced, navigated to fistula site, or allow magnets to align vessels sufficiently to create the fistula.
- •Evidence of calcification in vessels at the fistula site.
- •Evidence of active infections on the day of the index procedure.
- •Written informed consent not obtained.
结局指标
主要结局
Number of Participants With Procedural Success
时间窗: At time of procedure
Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.
Adverse Event Rate
时间窗: 3 months following endoAVF creation
Percentage of patients who experience one or more adverse events during the first 3 months following successful endoAVF creation. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC).
次要结局
- Number of Participants With Cannulation Success at Defined Follow-up Intervals(0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure)
- Percentage of Participants With Assisted Primary Patency at 6 Months(6 months post index procedure)
- Number of Participants With EndoAVF Related Reintervention(At 6 months follow-up)
- Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure(6 months post index procedure)
- Percentage of Participants With Primary Patency at 6 Months Post Index Procedure(6 months post index procedure)
- Time to Cannulation (Months)(Months from index procedure to cannulation)
- Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure(1, 3, and 6 months post index procedure)
- Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure(6 months post index procedure)
- Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure(6 months post index procedure)