The Role of Maintaining External Carotid Artery Flow in Graft Interposition After Carotid Endarterectomy
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
Slobodan Pesic
MD
Institute for Cardiovascular Diseases "Dedinje"
