Endovascular Versus Open Repair of the Common Femoral Artery: a Randomized Trial (TECCO)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 18
- 主要终点
- Morbid-mortality rate at 30 days
研究概览
简要总结
Even though the indication for endovascular therapy has been enlarged, open repair of common femoral artery is still considered as the treatment of choice. A recent pilot study showed that endovascular repair of the CFA seems to be a safe technique of revascularization with acceptable initial results at 12 months (Azema et al, Eur J Vasc Endovasc Surg, 2011, in press). TECCO, a French randomized and controlled trial, has been set up to compare open and endovascular procedures for the treatment of CFA atherosclerotic lesions.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 90 years-old
- •De novo atheromatous common femoral artery stenosis
- •Symptomatic lesions (Rutherford stages 3, 4, 5 and 6)
- •Haemodynamically significant lesion
- •Written informed consent
排除标准
- •Restenosis
- •Non-atheromatous lesions (dysplasia, post-traumatic, inflammatory)
- •external iliac thrombosis and / or common femoral side to treat
- •Contraindication to open surgery or endovascular treatment
- •Contraindication to anesthesia
- •Indication of aorto-femoral, ilio-femoral, femoral-popliteal or femoro-tibialis bypass to associate with the common femoral revascularization
- •Indication of a surgical approach to the external iliac artery through a retroperitoneal
- •Asymptomatic lesions
- •Life expectancy less than one year
- •Refusing patient
- •Inability to monitor during the test period
- •Participation in another clinical trial
- •Pregnant Women
- •No written informed consent
研究组 & 干预措施
Endovascular treatment
干预措施: Endovascular treatment using self expandable nitinol STENTS (Device)
Open repair treatment
干预措施: Open repair treatment (Device)
结局指标
主要结局
Morbid-mortality rate at 30 days
时间窗: 30 days
Morbid-mortality rate is defined by: Death, general complications and local complications requiring re-admission and / or reoperation.
次要结局
- Technical success(1 month)
- Hospital length of stay(1 month)
- Primary sustained clinical improvement(24 months)
- Target lesion revascularization(24 months)
- In-stent restenosis(24 months)
- Stent fracture(24 months)
- Secondary sustained clinical improvement(24 months)
- Target extremity revascularization(24 months)