跳至主要内容
临床试验/NCT04255316
NCT04255316已完成不适用

Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation

Pirogov Russian National Research Medical University2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2017年10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
126
试验地点
2
主要终点
Assessment of total stroke rate

研究概览

简要总结

A prospective comparative randomized single-centre non-inferiority trial. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation

详细描述

Introduction. Performing eversion endarterectomy some difficulties arise. Firstly, it requires a great deal of coherence between the work of the surgeon and the first assistant, as well as a great experience of the latter. Secondly, in some cases, there are difficulties in visualizing the distal margin of the intima: in the absence of a rigid skeleton, the soft unchanged artery walls after removal of the plaque subside, making it difficult to visualize possible fragments of the intima. Thirdly, the cost of the error is high: with a random de-version, repeated eversion turns out to be impossible. It should be noted that the use of an eversion technique becomes difficult to implement, and sometimes impossible, with extended stenosis, since a very high allocation of the ICA is required, which increases the invasiveness of the operation and the difficulty of access. With prolonged stenosis, the carotid endarterectomy remains the option of choice. The modification used eversion carotid endarterectomy combines the advantages of both methods, and also eliminates the limitations of the carotid endarterectomy and eversion carotid endarterectomy.

The aim of study. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with stenosis of ICA 70-99% (ultrasound - NASCET and CT angiography)
  • patients with a extensive lesion of the ICA (plaque < 2 cm) by ultrasound - NASCET and CT angiography

排除标准

  • patients with a extensive lesion of the ICA (plaque < 2 cm),
  • patients with a contralateral occlusion of the ICA
  • patients with stroke in ischemic type in the acute period.

结局指标

主要结局

Assessment of total stroke rate

时间窗: 30 days

assessment of the total stroke rate in patients undergoing intervention after 30 days

Assessment of mortality rate

时间窗: 30 days

assessment of the mortality rate in patients undergoing intervention after 30 days

次要结局

  • Assessment of stroke frequency(12 months)
  • Assessment of the incidence of internal carotid artery restenosis(3, 6, 12 months)

研究者

发起方
Pirogov Russian National Research Medical University
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验