NCT00523263已完成3 期
Heparin Bonded and Collagen Coated Polyester or Human Umbilical Vein for Femoropopliteal Bypass: a Prospective Randomised Multicentre Trial.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Primary and primary-assisted bypass patency
研究概览
简要总结
Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery.
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
- 31 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 31 to 89
- •intermittent claudication
- •ABI below 0.8
排除标准
- •non elective surgery
- •life expectancy below 2 yrs
- •contraindication for anticoagulant therapy
研究组 & 干预措施
Dacron
Active Comparator
Patients receiving polyester above-knee femoro-popliteal bypass
干预措施: heparin-bonded and collagen coated polyster (Device)
HUV
Active Comparator
patients receiving HUV femoro-popliteal bypass
干预措施: Human umbilical vein femoro-popliteal bypass (Device)
结局指标
主要结局
Primary and primary-assisted bypass patency
时间窗: 1 - 5 yrs
次要结局
- Secondary bypass patency(1 - 5 yrs)
研究者
研究点 (1)
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