Pilot Study of Autoarterial Remodeling of Bifurcation of the Common Carotid Artery

Study Overview
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Brief Summary
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Comparison of two methods for revascularization of the bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery

Official Title
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The New Technique of Carotid Endarterectomy With Autoarterial Remodeling of Bifurcation of the Common Carotid Artery.

Conditions
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Stenosis, Internal Carotid Artery

Intervention / Treatment
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* Procedure: Operation carotid endarterectomy with plastic of xenopericardial patch
* Procedure: New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stenotic lesions of the extracranial part of carotid arteries requiring surgical treatment according to national treatment guidelines (asymptomatic ICA stenosis more than 70% symptomatic ICA stenosis more than 65%) the length of the atherosclerotic plaques in the ICA than 1 cm personally signed Informed consent for participation in the study Exclusion Criteria: Chronic heart failure III-IV functional class NYHA classification Chronic decompensated lung heart Decompensated diseases of endocrine organs (diabetes glycemia more than 10 mmol/l) Severe hepatic or renal insufficiency (bilirubin >80 mmol/l, creatinine >200 mmol/l) Polyvalent drug Allergy; Malignant tumor in the terminal stage with life expectancy of up to 6 months; Acute disruption of cerebral blood flow Extensive occlusion of the internal carotid artery. Exacerbation of systemic diseases. Pregnancy and lactation. The refusal of a patient to sign informed consent for participation in the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: carotid endarterectomy patch angioplasty<br>Carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty | Procedure: Operation carotid endarterectomy with plastic of xenopericardial patch<br>* Under local anesthesia Sol.Novocaini 0.25%, wires or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Common carotid artery cut then performed a longitudinal arteriotomy on the front of the anterior surface of the internal carotid artery. Under the visual control performs a sequence of endarterectomy of the internal carotid artery. Plastic arteriotomy performed patche of ksenoperikardial (Kemperiplas-Neo) treated with epoxy compounds.<br>|
| Experimental: Carotid endarterectomy with autoarterial remodeling<br>Carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery | Procedure: New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA<br>* Under local anesthesia Sol.Novocaini 0.25%, or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Carotid glomus separated and moves downward and backward bifurcation of the common carotid artery. External carotid artery is cut off at an angle of 45º from the mouth with a portion of the common carotid artery, then performed a longitudinal arteriotomy on the front of the medial surface of the internal carotid and posterior-lateral surface of the external carotid artery. Under the visual control performs a sequence of endarterectomy of the internal and external carotid arteries. The final recovery of the arteries is performed by crosslinking of their walls with each other in a side by side type between the internal and external carotid arteries 6/0 Polypropylene thread with two needles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke or TIA | according to the examination of neurologist | throughout 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis | The percentage narrowing of the lumen at the bifurcation of the carotid artery at 1 year after surgery according to the ultrasound | 1 year | 
| Restenosis | The percentage narrowing of the lumen at the bifurcation of the carotid artery at 6 months after surgery according to the ultrasound | 6 months | 
| paresis of the cranial nerve | Neurological status after surgical treatment according to the examination of neurologist | up to 1 weeks | 
| The linear flow velocity in the region of the carotid artery bifurcation | The linear velocity of blood flow in the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound | 3rd day | 
| The linear flow velocity in the region of the carotid artery bifurcation | The linear velocity of blood flow in the bifurcation of the carotid artery after 6 months according to the ultrasound | 6 months | 
| The linear flow velocity in the region of the carotid artery bifurcation | The linear velocity of blood flow in the bifurcation of the carotid artery after 1 year according to the ultrasound | 1 year | 
| bleeding | 30 days after surgery | 1 month | 
| Stenosis | The percentage narrowing of the lumen at the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound | 3rd day | 
| Oxygenation of the brain | according to transcranial oximetry | during the surgical intervention | 
| Oxygenation of the brain | according to transcranial oximetry | 6 months | 
| Oxygenation of the brain | according to transcranial oximetry | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid endaretectomy