GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 293
- 试验地点
- 31
- 主要终点
- Target Lesion Primary Patency at 12 Months
研究概览
简要总结
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.
详细描述
The primary effectiveness hypothesis is to demonstrate that the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface will extend the period of target lesion primary patency as compared to PTA.
The primary safety hypothesis is to demonstrate that the proportion of subjects remaining free from major device, procedure, and treatment site-related adverse events through 30 days post-procedure in the GORE® VIABAHN® Device group is not inferior to that of the PTA group.
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
- •Hemodialysis patient with a dysfunctional or thrombosed forearm or upper arm prosthetic vascular access graft.
- •The target lesion starts less than or equal to 30 mm from the venous anastomosis.
- •The target lesion has > 50% stenosis as measured per protocol.
- •The patient has a maximum of one secondary stenosis.
排除标准
- •The age of the hemodialysis access graft is less than or equal to 30 days old from the date of the study procedure.
- •The patient has undergone an intervention (surgical or percutaneous) of the vascular access circuit less than or equal to 30 days from the date of the study procedure.
- •The secondary lesion is an occlusion.
结局指标
主要结局
Target Lesion Primary Patency at 12 Months
时间窗: 12 Months
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve.
Target Lesion Primary Patency at 24 Months
时间窗: 24 Months
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. P-Value calculated from 24-month data cohort after study completion.
Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure
时间窗: 30 days
The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.
Target Lesion Primary Patency at 6 Months
时间窗: 6 months
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve.
次要结局
- Assisted Primary Patency at 12 Months(12 months)
- Access Secondary Patency at 6 Months(6 months)
- Circuit Primary Patency [24 Months] Units Percentage of Subjects(24 months)
- Access Secondary Patency [12 Months] Units Percentage of Subjects(12 months)
- Access Secondary Patency [24 Months] Units Percentage of Subjects(24 months)
- Procedural Success(Following Index Procedure)
- Assisted Primary Patency at 6 Months(6 months)
- Assisted Primary Patency at 24 Months(24 months)
- Circuit Primary Patency(6 months)
- Circuit Primary Patency [12 Months] Units Percentage of Subjects(12months)
- Clinical Success(Following Index Procedure)
- Anatomic Success(Index Procedure)