NCT04634916招募中不适用
A Prospective, Multi-Center Clinical Study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis
C. R. Bard17 个研究点 分布在 2 个国家目标入组 220 人开始时间: 2021年3月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 17
- 主要终点
- Primary Patency
研究概览
简要总结
A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.
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
- •Subject must be either male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
- •Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- •Subject must be willing to comply with the protocol requirements, including clinical follow-up.
- •Subjects who have established, non-reversible kidney failure, who are currently on dialysis at screening or are in immediate need (within 6 months of endoAVF creation) of dialysis.
- •Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography.
- •Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Arteriogram.
- •Subject has adequate collateral circulation to the hand, in the opinion of the Investigator.
- •At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein.
排除标准
- •The subject is in a hypercoagulable state.
- •The subject has known bleeding diathesis.
- •The subject has insufficient cardiac output to support a native fistula in the opinion of the Investigator.
- •Known history of active intravenous drug abuse.
- •"Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure.
- •The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
- •The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
- •Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected).
- •The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
- •The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.
- •The subject has central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned endoAVF creation.
- •Absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography.
- •Occlusion or stenosis > 50% of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography.
- •Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and Duplex Ultrasound (DUS) or Venography.
- •Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the Investigator.
研究组 & 干预措施
EndoAVF
Experimental
干预措施: EndoAVF Creation (Device)
结局指标
主要结局
Primary Patency
时间窗: 6-months post index procedure
Subjects maintaining primary patency of the endoAVF
Device- and procedure-related serious adverse events (SAE)
时间窗: 30-days post index procedure
Freedom from device-related or procedure-related SAEs
Functional Cannulation Success
时间窗: 6-months post index procedure
The percentage of subjects dialyzed using successful 2-needle access of the endoAVF for at least 75% of dialysis sessions over a continuous 28-day period
次要结局
- Cannulation Success(6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
- Functional Cannulation Success(3-, 12-, 18-, and 24-months post index procedure)
- Post Procedural Secondary Procedures(2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
- Procedure Success(Index procedure)
- Primary Patency(6-weeks, 3-, 12-, 18-, and 24-months post index procedure)
- Functional Patency(through 24-months)
- Procedural Adjunctive Procedures(Index Procedure)
- Assisted Primary Patency(6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
- Physiological Maturation(2-weeks, 6-weeks, 6-months, and 24-months post index procedure)
- Functional Maturation(6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
- Secondary Patency(6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
- CVC Exposure/Use(6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
研究者
研究点 (17)
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