Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Primary patency at 3, 6, and 12 months
研究概览
简要总结
Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two areas of particular problems are the terminal portion of the cephalic vein near the shoulder and the central veins in the chest. Although angioplasty is standard of care the treated narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your dialysis access functional. Recently there has been introduction of a new technology called a covered stent graft. Initial studies suggest that placing this device across the area of narrowing leads to dialysis access staying open longer and needing less angioplasty treatments.
This study is designed to compare angioplasty (standard of care) versus using a covered stent graft. The investigators will then look at the dialysis records and future fistulograms to see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis patient with a mature forearm or upper arm access that was created > 2 months before enrollment in study.
- •The patient is ≥ 18 years of age.
- •The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
- •The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements.
- •The patient or his/her legal guardian is willing to provide informed consent.
- •The patient has lesions that meet the angiographic inclusion /
排除标准
- •and induce clinical, hemodynamic or functional abnormality.
- •Exclusion Criteria:
- •The patient has a known or suspected systemic infection.
- •The patient has a known or suspected infection of the hemodialysis access and / or bacteremia.
- •The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg per day), cyclosporine, tacrolimus, or cyclophosphamide.
- •The patient has known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
- •The patient has known sensitivity to heparin.
- •The patient is scheduled for a live donor kidney transplant.
- •The patient is enrolled in another investigational study or another access maintenance trial
- •The patient has comorbid conditions that may limit their ability to comply with the follow-up requirements
- •Life expectancy is ≤ 24 months.
- •The patient has an untreatable allergy to radiographic contrast material.
- •The patient is pregnant.
- •In the opinion of the operating physician, the patient's hemodialysis access circuit is unsuitable for endovascular treatment.
- •The patient's access is planned to be abandoned within 1 year.
- •The patient has indwelling catheters (dialysis, pacemakers, ports).
- •The patient has a central vein stent that would lead to jailing of the internal jugular vein.
- •The patient experiences angioplasty-induced venous rupture.
- •The patient has a flow limiting dissection after angioplasty.
- •The patient's hemodialysis access is thrombosed.
结局指标
主要结局
Primary patency at 3, 6, and 12 months
时间窗: 1 year
Target lesion primary patency at 3, 6, and 12 months
次要结局
- Secondary patency at 3, 6, and 12 months(1 year)