Visi-Pro™ Balloon Expandable Iliac Study (VISIBILITY™ Iliac)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Major Adverse Event Rate at 9 Months
研究概览
简要总结
The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System for the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or
- •Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
- •Willing to comply with all follow-up evaluations at the specified times.
- •Provides written informed consent prior to enrollment in the study.
排除标准
- •Previous implantation of stent(s) in the target vessel.
- •Received endovascular treatment of the target lesion within six months prior to the index procedure.
- •Known hypersensitivity to contrast material that cannot be adequately pretreated.
- •Known hypersensitivity to 316L stainless Steel.
- •Life expectancy of less than 12 months
研究组 & 干预措施
Visi-Pro™ Balloon Expandable Stent System
The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
干预措施: Visi-Pro™ Balloon Expandable Stent System (Device)
结局指标
主要结局
Major Adverse Event Rate at 9 Months
时间窗: 9 months
The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.
次要结局
未报告次要终点