NCT00712257终止不适用
A Prospective, Multicenter Trial to Evaluate the Safety and Performance of Spectranetics Laser With Adjunct PTA and GORE VIABAHN Endoprosthesis for the Treatment of SFA Instent Restenosis.
VIVA Physicians2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2007年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- 12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis.
研究概览
简要总结
A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or subject's legal representative informed of the study nature.
- •Subject understands the duration of the study and its follow up visit requirements.
- •Intermittent claudication extending through critical limb ischemia meeting a Rutherford 2-5 category.
- •Subject able to walk unassisted.
- •Female subjects of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.
排除标准
- •Life expectancy less than 12 months
- •Myocardial infarction less than 3 months prior to procedure
- •Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies and nitinol.
- •Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- •Uncontrolled hypercoagulability
结局指标
主要结局
12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis.
时间窗: 12 months
次要结局
- Target lesion revascularization will be evaluated at 12 mos. and defined as any pecutaneous or surgical intervention to treat a stenosis or cocclusion of the arget lesion treated at the index procedure.(12 month follow up)
研究者
研究点 (2)
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