Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODY™ Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients. The WAVE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 80
- 主要终点
- Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
研究概览
简要总结
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject provides written informed consent
- •Subject is male or female, with an age ≥ 18 years at date of enrollment.
- •Subject is willing to undergo all follow-up assessments.
- •Subject has a life expectancy ≥ 12 months.
- •Subject is undergoing chronic hemodialysis.
- •Subject has either a mature AVF or AVG in the arm.
- •Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.
- •Target lesion has ≥50% stenosis.
- •Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm
排除标准
- •Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
- •Subject has a stroke diagnosis within 3 months prior to enrollment.
- •Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
- •Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
- •Target lesion is located within a stent / stent graft.
研究组 & 干预措施
AVF Peripheral study treatment group
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
干预措施: Merit WRAPSODY Endovascular Stent Graft (Device)
AVF Peripheral control group
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
干预措施: PTA (Device)
AVG Anastomosis
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
干预措施: Merit WRAPSODY Endovascular Stent Graft (Device)
结局指标
主要结局
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
时间窗: 30 days
Proportion of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
时间窗: 6 months
Proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is 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.
次要结局
- Rates of procedure- and device-related adverse events involving the access circuit(Index procedure, 30 days, and months 6, 12 and 24.)
- Proportion of subjects with Target Lesion Primary Patency(12 and 24 months)
- Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)(6, 12 and 24 months)
- Proportion of subjects with Access Circuit Primary Patency (ACPP)(6, 12 and 24 months)
- Proportion of subjects with Post-Procedure Secondary Patency(6, 12 and 24 months)