Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 11
- 主要终点
- The percent diameter stenosis within the study lesion evaluated by conventional angiography.
研究概览
简要总结
This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.
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
- Single (Outcomes Assessor)
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
- •One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis
- •Symptoms of peripheral arterial disease (Rutherford 2-4)
排除标准
- •Pregnant, breastfeeding, or planning to become pregnant in the next 5 years
- •Less than 18 years old
- •Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
- •Previous stent in the study vessel
研究组 & 干预措施
Stent 1
Zilver® PTX Stent
干预措施: Zilver® Paclitaxel-Eluting Peripheral Stent (Device)
Stent 2
Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating
干预措施: Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating (Device)
Stent 3
Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
干预措施: Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating (Device)
结局指标
主要结局
The percent diameter stenosis within the study lesion evaluated by conventional angiography.
时间窗: 6 months
Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters.
次要结局
未报告次要终点