NCT00196066已完成2 期
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.
研究概览
简要总结
The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices. The stent self-expands once inside the artery where it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow over the stent helping to hold it in place.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has documented stenotic or occluded atherosclerotic lesions of the external iliac or common iliac artery.
- •Patient has a de novo or restenotic lesion(s) with no prior stent in the target lesion.
- •Patient has given informed consent.
排除标准
- •Patient is less than 50 years of age
- •Patient is participating in another investigational drug or device study.
- •Patient has multiple lesions (ipsilateral or in the aorta) that would require a staged procedure.
- •Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, nitinol, or contrast dye that cannot be adequately premedicated.
- •Patient is pregnant or breast-feeding.
结局指标
主要结局
The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.
次要结局
- Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement.
研究者
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