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

Not Applicable

Completed

• Conditions: Stenosis, Internal Carotid Artery
• Interventions: Procedure: Operation carotid endarterectomy with plastic of xenopericardial patch; Procedure: New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA

• Registration Number: NCT03027752
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-12
• Study First Submitted: 2017-01-15
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Primary Completion: 2018-09-30
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
carotid endarterectomy patch angioplasty	Operation carotid endarterectomy with plastic of xenopericardial patch	Carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty
Carotid endarterectomy with autoarterial remodeling	New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA	Carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery

Primary Outcome Measures

Name	Time	Method
Stroke or TIA	throughout 1 year	according to the examination of neurologist

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novosibirsk Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation