ACCESS: Prospective, Multi-center Trial of the Fusion Vascular Access Graft for Patients Who Require Early Vascular Access for Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 149
- 试验地点
- 15
- 主要终点
- Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis
研究概览
简要总结
The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion™ Vascular Access Graft for patients in need of early vascular access for hemodialysis.
详细描述
The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion™ Vascular Access Graft for patients in need of early vascular access for hemodialysis. The primary objective is to demonstrate that secondary patency at 6 months for the Fusion™ Vascular Access Graft is not less than an objective performance criterion (OPC) minus a clinically relevant margin (δ). The OPC represents secondary patency at 6 months for the standard of care access grafts.
The secondary safety endpoint is the occurrence of CEC-adjudicated device or procedure related adverse events through 24 months post implant procedure, or through discharge for patients with unsuccessful device implantation. Secondary efficacy endpoints include:primary patency; primary assisted patency; ability to revise a failed graft; early access capability; time to hemostasis.
Subjects will undergo a thorough medical assessment and physical examination pre-procedure and will be assessed peri-procedure. Enrolled subjects with a device implanted will be evaluated at 1, 6, 12, 18 and 24 months post implant procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Need for early dialysis access (≤72 hours after implantation):
- •Initiation of maintenance dialysis is recommended per K/DOQI or institutional guidelines; or
- •Patient is currently receiving dialysis via catheter
- •No prior implantation of synthetic graft in the arm to be treated
- •Life expectancy of at least 2 years, based on physician's assessment of medical condition
排除标准
- •Patient younger than 18 years of age
- •Any stenosis in the veins proximal to (downstream of) implant site, as determined previously or by current ultrasound
- •Bleeding disorder, e.g., low platelet count (<50,000), hypercoagulable state, e.g., antithrombin III deficiency; antiphospholipid or anticardiolipin antibodies; Factor V Leiden; circulating Lupus anticoagulant; current, active heparin-induced thrombocytopenia; Protein C or S deficiency; or history of recurrent deep vein thrombosis not related to AV access.
- •Active malignancy, e.g., condition either being treated or considered untreatable
- •Active systemic infection, e.g., condition either being treated or considered untreatable
- •Uncontrolled major symptomatic medical problem, e.g., undiagnosed severe pain, metabolic disturbance, fever, etc.
- •Likelihood of poor compliance to required dialysis protocol, e.g., history of poor attendance to required clinic sessions or non-compliance to medication
- •Mental incapacity; inability to understand treatment instructions
- •Currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
结局指标
主要结局
Secondary patency at 6 months as determined by ability of the graft to be used for vascular access for hemodialysis
时间窗: 6 Months
次要结局
未报告次要终点