NCT00776906已完成不适用
Advance® 18PTX® Balloon Catheter Study: Treatment of Lesions in Superficial Femoral Artery/Popliteal Artery With a Paclitaxel-coated Balloon
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Evaluation of Late Lumen Loss
研究概览
简要总结
The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the superficial femoral artery and popliteal 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
- 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
- •Age >18 years.
- •Able to provide informed consent.
- •Has at least one de novo or restenotic lesion(s) with > 70% stenosis documented angiographically of the SFA or popliteal artery. If more than one lesion requires intervention, only one should be treated as a study lesion.
排除标准
- •Has significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure.
- •Lack of at least one patent runoff vessel with < 50% stenosis throughout its course.
- •Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery.
研究组 & 干预措施
1
Experimental
PTX-coated balloon
干预措施: Advance® 18PTX® Balloon Catheter (Device)
2
Active Comparator
Bare balloon
干预措施: Advance® 18LP Balloon Catheter (Device)
结局指标
主要结局
Evaluation of Late Lumen Loss
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (4)
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