Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit (WRAP North America)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 19
- 主要终点
- Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
研究概览
简要总结
The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population. Participants treated with the WRAPSODY CIE device in accordance with the device instructions for use will be followed in accordance with standard of care up to 3-years post-procedure.
详细描述
Prospective, multicenter, observational study to evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit (WRAP North America)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject provides written informed consent for study participation.
- •Subject is male or female, with an age ≥ 18 years at date of enrollment.
- •Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 36 months.
- •Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon.
- •The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.
- •Subject has stenosis or occlusion within the dialysis outflow circuit and is treated with WRAPSODY CIE in accordance with device instructions for use.
排除标准
- •Subject has a planned surgical revision of access site.
- •Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
- •Subject has an uncorrectable coagulation disorder.
- •Known hypersensitivity to nickel or titanium.
- •Subject's hemodialysis access is anticipated to be abandoned within 6 months.
- •Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.
- •Full expansion of a PTA balloon cannot be achieved during predilatation.
- •Device would be placed in the Superior Vena Cava
- •Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.
结局指标
主要结局
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
时间窗: 6 months
The proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 months. Target Lesion Primary Patency (TLPP) defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
时间窗: 30 days
Proportions of subjects without any localized or systematic safety events through 30 days post-procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including CD-TLR or target lesion thrombosis)
次要结局
- Proportion of subjects with Target Lesion Primary Patency(12, 24 and 36 months)
- Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)(6, 12, 24 and 36 months)
- Proportion of subjects with Access Circuit Primary Patency (ACPP)(6, 12, 24 and 36 months)
- Proportion of subjects with Target Lesion Primary Patency(12, 24 and 36 months)
- Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)(6, 12, 24 and 36 months)
- Proportion of subjects with Access Circuit Primary Patency (ACPP)(6, 12, 24 and 36 months)
- Rates of procedure- and device-related adverse events(Index procedure, 30 days, 6, 12, 24 and 36 months)