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

M

Meshalkin Research Institute of Pathology of Circulation

Status

Completed

Conditions

Stenosis, Internal Carotid Artery

Treatments

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

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT03027752
N-RICP-346

Details and patient eligibility

About

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

Enrollment

200 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

carotid endarterectomy patch angioplasty
Active Comparator group
Description:
Carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty
Treatment:
Procedure: Operation carotid endarterectomy with plastic of xenopericardial patch
Carotid endarterectomy with autoarterial remodeling
Experimental group
Description:
Carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery
Treatment:
Procedure: New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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