GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Primary Assisted Patency
研究概览
简要总结
This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.
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
- •Symptomatic peripheral arterial disease in superficial femoral artery lesions
排除标准
- 未提供
结局指标
主要结局
Primary Assisted Patency
时间窗: 12 and 24 months
Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point.
Freedom From Target Lesion Revascularization
时间窗: 1, 12 and 24 months
Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point.
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies
时间窗: Procedure day, 1, 12, 24, 36, 48 and 60 months
The number and proportion of the subjects for whom the occurrence of serious adverse events were reported.
Number of Participants With a Stent Fracture
时间窗: Month 12, 24, 36, 48 and 60
The number and proportion of stent fracture as assessed by Core lab
次要结局
未报告次要终点