Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy. Long-term Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 主要终点
- carotid artery restenosis
研究概览
简要总结
This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.
This study was run at the University of Roma, La Sapienza and at the University of Poitiers, randomisation was done in both enters after approval by the Ethical committee of the University of Roma (Record uploaded)
详细描述
This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.
598 patients were considered for randomisation between January 1995 and January 2004. The following patients were excluded for randomisation (Redo carotid surgery: N=34, radiation induced carotid stenosis:N=45, indication for carotid bypass: N=65, Refusal of randomisation: N=4).
In total, 450 patients were randomized in two groups, 225 received a polyester patch and 225 received a polyurethane patch.
All patients were operated under general anaesthesia and all received an intraoperative angiography. A shunt was selectively used in patients with a recent stroke (<15 days) or with a contralateral carotid occlusion
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
- 25 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Carotid stenosis > 60% NASCET criteria
排除标准
- •Redo carotid surgery
- •Radiation induced carotid stenosis
- •Extensive carotid lesion > 5 cm in length with involvement of the common carotid artery best treated by a carotid bypass
结局指标
主要结局
carotid artery restenosis
时间窗: 5 to 10 years after surgery
Restenosis of carotid endarterectomy \> 70% in diameter occurring 5 to 10 years after surgery diagnosed by color duplex ultrasound
次要结局
- Any ipsilateral stroke(0 days to 10 years)
- Any death occurring during follow-up(Time 0 (operation) to 10 years after surgery)