Vessel-Select Catheter System Feasibility Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 主要终点
- Number of Participants With Sufficient Patency for Clinical Access
研究概览
简要总结
Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.
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
- •Patients deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment
- •Patients diagnosed with chronic kidney disease classification stage IV or V
- •Adequate quality vein >= 2 mm with confirmed clinically significant outflow based on pre-operative assessment
- •Adequate quality radial artery >= 2 mm based on pre-operative assessment
- •Adequate collateral arterial perfusion
- •Radial artery-adjacent vein proximity < = 1.5 mm
- •Able to provide informed consent
- •Able to travel to institution for follow up examination
- •Able to intraoperatively place an .014" guidewire in artery
排除标准
- •Suspected skin disease
- •Immunocompromised patients (e.g. HIV positive)
- •Edema of extremities
- •Current diagnosis of carcinoma
- •Pregnancy or currently breast feeding
- •Diagnosed hypercoaguable state
- •Active infection
- •Evidence of vascular disease at target site
- •Pre-existing vascular disease that could confound study results
- •Vessel tortuosity or spasm preventing placement of .014" guidewire
结局指标
主要结局
Number of Participants With Sufficient Patency for Clinical Access
时间窗: 6 weeks
Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.
Number of Patients Achieving Dialysis Access
时间窗: 6 weeks
Arteriovenous fistula is mature and patient has started dialysis using the fistula
Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis
时间窗: 3 months
Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis
次要结局
- Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access(12 weeks)