NCT03027752已完成不适用
The New Technique of Carotid Endarterectomy With Autoarterial Remodeling of Bifurcation of the Common Carotid Artery.
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2016年12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
- 200
- 试验地点
- 2
- 主要终点
- Stroke or TIA
研究概览
简要总结
Comparison of two methods for revascularization of the bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stenotic lesions of the extracranial part of carotid arteries requiring surgical treatment according to national treatment guidelines (asymptomatic ICA stenosis more than 70% symptomatic ICA stenosis more than 65%)
- •the length of the atherosclerotic plaques in the ICA than 1 cm
- •personally signed Informed consent for participation in the study
排除标准
- •Chronic heart failure III-IV functional class NYHA classification
- •Chronic decompensated "lung" heart
- •Decompensated diseases of endocrine organs (diabetes glycemia more than 10 mmol/l)
- •Severe hepatic or renal insufficiency (bilirubin >80 mmol/l, creatinine >200 mmol/l)
- •Polyvalent drug Allergy;
- •Malignant tumor in the terminal stage with life expectancy of up to 6 months;
- •Acute disruption of cerebral blood flow
- •Extensive occlusion of the internal carotid artery.
- •Exacerbation of systemic diseases.
- •Pregnancy and lactation.
- •The refusal of a patient to sign informed consent for participation in the study
结局指标
主要结局
Stroke or TIA
时间窗: throughout 1 year
according to the examination of neurologist
次要结局
- bleeding(1 month)
- Stenosis(3rd day)
- Restenosis(6 months)
- paresis of the cranial nerve(up to 1 weeks)
- The linear flow velocity in the region of the carotid artery bifurcation(1 year)
- Oxygenation of the brain(1 year)
研究者
研究点 (2)
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