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临床试验/NCT06528717
NCT06528717招募中不适用

The Role of Maintaining External Carotid Artery Flow in Graft Interposition After Carotid Endarterectomy

Institute for Cardiovascular Diseases "Dedinje"1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
stroke ipsilateral to the procedure

研究概览

简要总结

Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.

详细描述

Surgical and endovascular treatment have been shown as effective treatment modalities in symptomatic and asymptomatic patients at high risk of stroke on medical therapy with significant carotid artery stenosis. Eversion carotid endarterectomy (eCEA) has proven effective as a surgical treatment modality. In highly selected instances carotid bypass may be indicated as a bailout procedure or primarily as a preoperatively planned maneuver. Usually, the decision for substitution of carotid bifurcation with a synthetic graft is made due to an extensive, severe atherosclerotic process on the distal part of the extracranial internal carotid artery, the presence of uncontrollable atherosclerotic plaque after endarterectomy, and in cases when an exceptionally thin artery wall remains after endarterectomy.

Several techniques have been described for substituting carotid bifurcation with a synthetic graft. The most common technique involves complete resection and excision of the carotid bifurcation and reconstruction with graft interposition between the undiseased segment of the common carotid artery (CCA) proximally and the internal carotid artery (ICA) distally by creating proximal and distal end-to-end anastomoses. This technique requires ligation and exclusion of the external carotid (ECA) and the superior thyroid artery from circulation. The less common techniques that preserve flow through the external carotid artery are performed as a primary option for treatment without previous endarterectomy and are seldom applied. Currently, there are no recommendations regarding the administration of carotid bypass, nor comparisons of these techniques.

In this study, the investigators are comparing a technique with graft interposition between endarterectomized CCA (creation of side-to-end anastomosis) and the distal segment of the ICA (end-to-end anastomosis) after failure of eCEA to provide technical success with the described common interposition by end-to-end anastomoses proximally and distally. Therefore, the role of flow preservation through the ECA could be defined.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •symptomatic carotid stenosis (> 50%)
  • •unilateral asymptomatic carotid stenosis (> 60%)
  • •bilateral asymptomatic carotid stenosis (> 60%)

排除标准

  • •carotid restenosis
  • •"major surgery" in previous 6 months
  • •previous brain trauma or surgery
  • •malignant disease
  • •carotid artery aneurysm

结局指标

主要结局

stroke ipsilateral to the procedure

时间窗: through study completion, an average of 2 years

development of new neurological events that are pathophysiological atributable to the operated side

myocardial infarction

时间窗: 30 days

development of new acute coronary events during perioperative period

periprocedural stroke and death

时间窗: 30 days

onset of new neurological deficit or death during perioperative period

次要结局

  • restenosis rate(through study completion, an average of 2 years)
  • patient survival(through study completion, an average of 2 years)
  • graft patency(through study completion, an average of 2 years)

研究者

发起方
Institute for Cardiovascular Diseases "Dedinje"
申办方类型
Other
责任方
Principal Investigator
主要研究者

Slobodan Pesic

MD

Institute for Cardiovascular Diseases "Dedinje"

研究点 (1)

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