Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 13
- 主要终点
- Physiologic Maturation
研究概览
简要总结
This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access. People with kidney failure often require dialysis, which depends on having a reliable arteriovenous fistula (AVF). Traditionally, AVFs are created with surgery, but surgery can involve incisions, longer recovery, and sometimes additional procedures before the AVF can be used.
The Velocity System is designed to create an AVF through a small puncture in the skin using a catheter-based approach, without open surgery. This pivotal study will assess how safe the procedure is and how well it works for patients who need dialysis.
The study will take place at multiple centers in the United States and will enroll adults with kidney failure who are candidates for fistula creation. Participants will undergo the Velocity procedure and then be followed closely with exams, ultrasounds, and dialysis assessments for up to five years.
Taking part is voluntary. Patients may benefit from a less invasive approach to dialysis access, but the main goal is to collect information that could improve future care for people with kidney failure.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months
- •Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm
- •Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm
- •Age > 18 years and < 80 years
- •Willing and competent to give written informed consent
- •Willing and able to complete all study assessments and follow-up requirements
排除标准
- •Study extremity systolic blood pressure < 100mmHg
- •Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
- •Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.
- •Distance between Cubital Perforating Vein and Proximal Radial Artery > 3.0 mm
- •Cephalic vein diameter < 2.5 mm at any point from the CPV to the axillary vein
- •Central venous occlusion ipsilateral of the study extremity
- •Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.
- •Evidence of active systemic infections or localized to the procedure access site within the past 7 days
- •History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- •Any contraindication to antiplatelet therapy
- •Currently being treated with another investigational device or drug
- •Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
- •Uncontrolled or poorly controlled diabetes defined as a HbA1C > 10%
- •Known hypercoagulable condition, bleeding diathesis or coagulation disorder
- •Lymphedema of the study extremity
- •Scheduled kidney transplant within 6 months of enrollment
- •Peripheral white blood cell count < 1,500 cells/μL or > 13,000 cells/μL and neutrophil > 80%
- •Platelet count < 75,000 cells/ μL
- •Current diagnosis of carcinoma (unless in remission > 1 year)
- •Pregnant or currently breast feeding
- •Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System
- •Any other medical condition that in the opinion of the investigator would put the welfare of the subject at risk or confound interpretation of the study data
- •Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.
研究组 & 干预措施
Velocity pAVF System Treatment Arm
Participants in this single-arm, open-label study will undergo creation of a dialysis access using the Velocity Percutaneous Arteriovenous Fistula (pAVF). The Velocity pAVF is designed to create an arteriovenous fistula (AVF) using a minimally invasive, catheter-based procedure through the skin, rather than open surgery. All subjects enrolled will receive the Velocity pAVF procedure. After the procedure, participants will be followed with physical examinations, duplex ultrasound, and dialysis assessments to evaluate fistula maturation, usability for hemodialysis, and long-term function. Additional procedures, if needed to assist maturation or maintain access function, will be recorded. Safety will be monitored throughout the study, including assessment of device-related and procedure-related complications.
干预措施: Velocity Percutaneous Arteriovenous Fistula (Device)
结局指标
主要结局
Physiologic Maturation
时间窗: 6 weeks
The proportion of participants that reach the binary outcome of Physiologic Maturation. Physiologic Maturation is a composite measure, reached when Duplex ultrasound demonstrates a brachial artery blood flow of ≥ 500 ml/min and an outflow vein diameter of ≥ 5 mm.
Serious Adverse Device Effect
时间窗: 30 days
Any Serious Adverse Event that reasonably suggests is caused by the device or procedure
次要结局
- Physiologic Maturation(3 months)
- Functional Maturation(6 months)
- Unassisted Functional Maturation(6 months)
- Velocity pAVF Primary Patency(Assessed up to 5 years)
- Time to First Hemodialysis(Through 12 month follow up, on average at 3 months)
- Number of Catheter Days(Through 12 month follow up, on average at 3 months)
- Access Circuit Primary Patency(Assessed up to 5 years)
- Access Circuit Cumulative Patency(Assessed up to 5 years)
- Technical Success(Immediately after the intervention)
- Procedural Success(Immediately after the intervention)
- Freedom from Reintervention(Assessed up to 5 years)
- Total Reinterventions(Assessed up to 5 years)
- Freedom from Serious Adverse Events(Assessed up to 5 years)