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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Carotid Stenosis, Carotid Artery Diseases

Intervention / Treatment
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* Procedure: Modified method of eversion carotid endarterectomy
* Procedure: Standard method of eversion carotid endarterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified eversion<br>Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a modified eversion carotid endarterectomy | Procedure: Modified method of eversion carotid endarterectomy<br>* Mini approach for CCA bifurcation - Clamping ICA, ECA and CCA - ICA is cut off with a scalpel at the mouth itself - Dissection of the ICA and ECA in the distal direction to the distal border of the atherosclerotic plaque - Endarterectomy - Performing of a new bifurcation of the CCA with prolene 7/0<br>|
| Active Comparator: Standard eversion<br>Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a standard eversion carotid endarterectomy | Procedure: Standard method of eversion carotid endarterectomy<br>* standard eversion technic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of total stroke rate | assessment of the total stroke rate in patients undergoing intervention after 30 days | 30 days | 
| Assessment of mortality rate | assessment of the mortality rate in patients undergoing intervention after 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of stroke frequency | assessment of stroke frequency in patients undergoing intervention after 12 months | 12 months | 
| Assessment of the incidence of internal carotid artery restenosis | Assessment of the incidence of internal carotid artery restenosis after 3, 6 and 12 months | 3, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid endarterectomy, eversion carotid endarterectomy, prophylaxis of ischemic stroke, carotid arteriosclerosis, carotid artery plasty