NCT00541307已完成不适用
Post Marketing Study of the GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease (VIPER)
W.L.Gore & Associates10 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2007年10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
- 119
- 试验地点
- 10
- 主要终点
- Primary Patency at 12 Months
研究概览
简要总结
The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.
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
- •lifestyle limiting claudication, rest pain or minor tissue loss>
- •ABI (ankle-brachial index) < 0.9 or TBI (toe-brachial index) < 0.5 if ABI is >0.9
- •Stenosis (>50%) or occlusion of native SFA (superficial femoral artery) >5cm
- •Orifice and 1 cm of SFA are patent
- •Popliteal artery is patent at the intercondylar fossa of the femur to the trifurcation
- •At least 1 patent run off vessel
- •Guidewire and deliver system successfully traversed the lesion
排除标准
- •Untreated flow-limiting aortoiliac occlusive disease
- •Any previous stenting or surgery in the target vessel
- •Femoral or popliteal aneurysm of target vessel
- •No patent tibial arteries
- •Prior ipsilateral femoral artery bypass
- •Major distal amputation (above the transmetatarsal) in either limb
- •Patients with known sensitivity to Heparin
结局指标
主要结局
Primary Patency at 12 Months
时间窗: 12 months
Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area).
次要结局
- Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days(30 days)
- Primary Assisted Patency(12 months)
- Secondary Patency(12 months)
- Device-related Major Adverse Events at 12 Months(12 months)
研究者
研究点 (10)
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