NCT00147979已完成不适用
Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
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
- 596
- 试验地点
- 1
- 主要终点
- Primary patency after 2 years
研究概览
简要总结
Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin
详细描述
Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin.
Evaluation of this comparison by clinical systems: ankle-arm index, duplex echo, follow-up of 2 years
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
- Double (Participant, Investigator)
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
- •Patients with Peripheral Vascular Diseases with complaints of invalidating claudication, rest pain, ucera or gangrene
- •Patients with damage of the arteria femoralis superficialis or poplitea, longer than 6 cm
- •Reasonable outflow arteria
- •Informed consent
- •Patient able to take part in all follow-up examinations
排除标准
- •Acute ischemia of the leg
- •Patients with a ipsilateral inflow stenosis of more than 70% which can not be corrected before or during the surgery
- •< 18 years
- •Pregnancy
- •Recent heart attack (< 1 month)
- •Life expectancy less than 12 months
- •Known allergy to heparin
- •Known contrast allergy
- •Known bleeding or coagulation disorder
研究组 & 干预措施
1
Experimental
PTFE with bounded heparin
干预措施: Bridging by PTFE with bounded heparin (Device)
2
Active Comparator
PTFE without bounded heparin
干预措施: Bridging by PTFE without bounded heparin (Device)
结局指标
主要结局
Primary patency after 2 years
时间窗: after 2 years
次要结局
- Secondary patency(after 2 years)
- Limb salvage(after 2 years)
- Mortality(after 2 years)
- Re-intervention(after 2 years)
研究者
研究点 (1)
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