NCT02110524已完成不适用
Prospective, Controlled, Multi-Center, Open, Single Arm Study for the Treatment of Subjects Presenting De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using a Paclitaxel-Coated Percutaneous Angioplasty Catheter
Spectranetics Corporation2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Primary endpoint: Angiographic late lumen loss
研究概览
简要总结
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or popliteal arteries.
The primary endpoint for this analysis is late lumen loss at six (6) months.
详细描述
Prospective, controlled, multi-center, open, single arm study
Main cohort: 50; pre-specified treatment group: 30. Total patients: 80
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
- •Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery
- •De novo or restenotic lesion(s) >70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation).
- •Target vessel reference diameter ≥3 mm and ≤7 mm (by visual estimation).
- •Rutherford classification of 2, 3 or 4
排除标准
- •Lesion length is <3 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.
- •Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.
- •Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.
结局指标
主要结局
Primary endpoint: Angiographic late lumen loss
时间窗: 6Month
difference between minimum lumen diameter after intervention and follow up.
次要结局
- Secondary safety endpoint: Major Adverse Event (MAE) rate(6Months)
研究者
研究点 (2)
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