Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 24
- 主要终点
- Cumulative Patency Through 12 months Post-AVF Creation
研究概览
简要总结
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
详细描述
The primary objective of this post-market surveillance study is to support the short-term safety of the device and procedure and further assess long-term safety and effectiveness in subjects treated by newly trained providers of the Ellipsys Vascular Access System in the creation of a native AV fistula via percutaneous access in subjects who are on hemodialysis and are medically indicated for the creation of an upper limb anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female ≥ 18 years of age and ≤ 80 years of age
- •Life expectancy of at least one year, in the investigator's opinion
- •Diagnosed with ESRD or chronic kidney disease on hemodialysis.
- •Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment
- •Adequate quality vein based on pre-operative assessment
- •Adjacent vein diameter of ≥2.0 mm at target anastomosis site
- •Confirmed clinically significant outflow
- •Adequate quality radial artery based on pre-operative assessment
- •a. Arterial lumen diameter of ≥2.0 mm at target anastomosis site
- •Adequate collateral arterial perfusion with patent palmar arch as demonstrated by Barbeau Test or Allen's Test.
- •Radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
- •Patient is able to provide written informed consent and attend follow-up examinations at the enrolling institution
- •Imaging-based Inclusion Criteria:
- •Confirm radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedurally
- •Confirm radial artery and adjacent vein diameter of ≥2.0 mm at target anastomosis site
排除标准
- •Pre-existing ipsilateral vascular disease interfering with the study procedure or potentially confounding the study results including:
- •Documented or suspected central venous stenosis (≥ 50%) or
- •Upper extremity arterial stenosis or
- •Vascular disease at the radial artery / adjacent vein site
- •Prior vascular surgery at or proximal (central) to the AVF target site interfering with AVF maturation or other ipsilateral surgery that could potentially confound the study results such as prior axillary dissection or mastectomy
- •History of steal syndrome from a previous surgical ipsilateral hemodialysis vascular access which required intervention or abandonment
- •Systolic pressures < 100 mg Hg at the time of screening
- •Suspected or confirmed skin disease at the skin entry site
- •Edema of the upper extremity on the ipsilateral side
- •Immunocompromised subjects due to underlying disease or immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 10 mg per day
- •Known bleeding diathesis, coagulation disorder or medications putting the subject at increased risk, in the Investigator's judgment
- •Patients with acute or active infection
- •Scheduled kidney transplant within 6 months of enrollment
- •Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)
- •History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment
- •Patient has an active COVID-19 infection with ongoing sequela or hospitalization for treatment of COVID-19.
研究组 & 干预措施
Ellipsys Vascular Access System
The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients who have chronic kidney disease requiring dialysis.
干预措施: Ellipsys Vascular Access System (Device)
结局指标
主要结局
Cumulative Patency Through 12 months Post-AVF Creation
时间窗: 12 months post-procedure
Freedom from access abandonment from time of access creation
Early Occlusion Rate at 7 days
时间窗: 7 days post-procedure
Percent of patients with total occlusion within 7 days of the AVF creation procedure
Study Related Serious Adverse Event (SAE) Rate Through 12 months
时间窗: 12 months post-procedure
Rate of serious adverse events through 12 months related to the device, study procedure, or secondary procedure to maintain or re-establish patency.
次要结局
- Assisted Primary Patency Through 12 months Post-AVF Creation(12 months post-procedure)
- Overall Patient Safety(12 months post-procedure)
- Primary Patency Through 12 months Post-AVF Creation(12 months post-procedure)
- Secondary Procedures Rate(12 months post-procedure)