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临床试验/NCT06207643
NCT06207643招募中不适用

Conventional Vs. Eversion Carotid Endarterectomy Immediate and Short-Term Outcomes

Sohag University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
postoperative immediate and short term complications

研究概览

简要总结

the goal of this interventional study is to compare between the conventional and the Eversion techniques in performing carotid endarterectomy in patients with carotid artery stenosis the main question it aim to answer is which technique is much more safe and effective the participants will have carotid endarterectomy by one of the two techniques the researcher will compare the group subjected to conventional carotid endarterectomy and the group subjected to Eversion carotid endarterectomy to see which technique is more effective and safe

详细描述

Carotid endarterectomy (CEA) is widely recognized as the gold standard approach for the prevention of major cerebral events in patients with significant carotid stenosis as it is considered as cerebral revascularization. The procedure entails removing the plaque from the common carotid artery (CCA) and internal carotid artery (ICA) to improve blood flow, prevent potential embolic material and therefore restoring proper cerebral blood flow.

Carotid endarterectomy (CEA) has proven to be a safe and durable operation to decrease the risk of stroke in both symptomatic and asymptomatic patients with extracranial carotid artery stenosis. it is recommended for most symptomatic patients with 50%-99% ICA stenosis. It's considered for asymptomatic patients with 60% - 99%.

There are two main techniques of CEA, conventional carotid endarterectomy (C-CEA) and eversion carotid endarterectomy (E-CEA). More often used is conventional carotid endarterectomy (C-CEA) which is consists of a vertical arteriotomy begun on the CCA and continued through the carotid bifurcation into the ICA beyond the full length of the plaque and closure by patch angioplasty.

As regard comparison between (C-CEA) and (E-CEA) Several studies showed that C-CEA and E-CEA are equally effective surgical approaches for extracranial carotid occlusive disease and studies that compared the influence of E-CEA and C-CEA on postoperative results had varied conclusions some studies have reported no difference in restenosis rates while others have reported less restenosis in eversion endarterectomy. more studies are needed to approve such results, Therefore, it remains difficult to choose the optimal endarterectomy technique.

the study will include 40 patients divided into two groups 20 patients for each group, each group will be subjected to one technique to compare safety and efficacy of each one.

研究设计

研究类型
Interventional
分配方式
Non 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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients having carotid artery stenosis with cerebral events (recent stroke).
  • •Patients having high grade carotid artery stenosis with increasing symptoms.
  • •Patients underwent previously CEA presented with carotid restenosis.

排除标准

  • •Non atherosclerotic carotid artery stenosis e.g., vasculitis, collagen vascular diseases and hypoplastic ICA.
  • •patients with recently thrombosed ICA.
  • •High carotid bifurcation to the extent makes CEA not accessible in easy or safe way e.g., increased risk of cranial nerve injury.
  • •acute ischemic stroke within less than 2 weeks before the procedure.

研究组 & 干预措施

group (A) conventional CEA

Active Comparator

this group of patients will be subjected to carotid endarterectomy using the conventional technique of this procedure

干预措施: carotid endarterectomy (Procedure)

group (B) Eversion CEA

Active Comparator

this group of patients will be subjected to carotid endarterectomy using the Eversion technique of this procedure

干预措施: carotid endarterectomy (Procedure)

结局指标

主要结局

postoperative immediate and short term complications

时间窗: 4 weeks postoperative following end of hospital dismiss

occurrence of cerebrovascular stroke

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kariem Ayman Mohamed

assistant lecturer of vascular surgery Sohag university

Sohag University

研究点 (1)

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