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

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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Novosibirsk Research Institute of Circulation Pathology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: carotid endarterectomy patch angioplasty; Carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty	Procedure: Operation carotid endarterectomy with plastic of xenopericardial patch; 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.
Experimental: Carotid endarterectomy with autoarterial remodeling; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: January 15, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: carotid endaretectomy
• Other Study ID Numbers: N-RICP-346