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

NCT ID: NCT03027752

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-10-31

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

Conditions

Stenosis, Internal Carotid Artery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

carotid endarterectomy patch angioplasty

Carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty

Group Type: ACTIVE_COMPARATOR

Operation carotid endarterectomy with plastic of xenopericardial patch

Intervention Type: PROCEDURE

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.

Carotid endarterectomy with autoarterial remodeling

Carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery

Group Type: EXPERIMENTAL

New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, , Russia

Countries

Russia

Other Identifiers

N-RICP-346

Identifier Type: -

Identifier Source: org_study_id