GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 17
- 主要终点
- Number of Subjects With Loss of Primary Patency of Target Lesion
研究概览
简要总结
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who developed stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
- •Participants who was used to repair vascular access circuits for purposes other than treatment of stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
排除标准
- 未提供
结局指标
主要结局
Number of Subjects With Loss of Primary Patency of Target Lesion
时间窗: up to 2 years
Primary patency of target lesion is defined as the period during the patency was maintained from initial treatment until occlusion of target lesion or re-treatment of target lesion.
Number of Subjects With Loss of Secondary Patency of Target Lesion
时间窗: up to 2 years
Secondary patency of target lesion is defined as the period during the patency was maintained from initial treatment (including the period of patency after re-treatment).
Number of Subjects With Loss of Primary Patency of Vascular Access Circuit
时间窗: up to 2 years
Primary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until occlusion in vascular access or re-treatment in vascular access circuit.
Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit
时间窗: up to 2 years
Secondary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until discontinuation of the use of vascular access circuit.
Mean Cumulative Number of Re-treatment Per Target Lesion
时间窗: at 24 months
Mean cumulative number of re-treatment in target lesion is defined as the number of re-treatment performed for target lesion after the initial treatment.
Number of Subjects Achieving Technical Success
时间窗: Day 1
Technical Success is defined as \< 30% residual stenosis after initial treatment.
Number of Subjects Achieving Clinical Success
时间窗: Day 1 to Month 1 follow up
Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.
Number of Subjects Experiencing Device and Procedure-related Adverse Events
时间窗: Day 1 to Month 1 follow up
An adverse event (AE) is defined as any unfavorable or unintended sign (including abnormal laboratory changes), symptom, or illness associated with the use of a medical device. Unless worsening of severity or increasing of incidence during the surveillance, the primary disease of the patient is not considered an adverse event.
Number of Subjects Experiencing Device Defects
时间窗: Day 1 to Month 1 follow up
A device defect is defined as a defect such as damage, malfunction, etc. that are widely unfavorable. Regardless of whether they are due to design, marketing, distribution, or use.
次要结局
未报告次要终点