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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03027752
Enrollment
200
Registered
2017-01-23
Start date
2016-12-31
Completion date
2018-10-31
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stenosis, Internal Carotid Artery

Keywords

carotid endaretectomy

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

Interventions

PROCEDUREOperation 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.

PROCEDURENew 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.

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stroke or TIAthroughout 1 yearaccording to the examination of neurologist

Secondary

MeasureTime frameDescription
Restenosis1 yearThe percentage narrowing of the lumen at the bifurcation of the carotid artery at 1 year after surgery according to the ultrasound
paresis of the cranial nerveup to 1 weeksNeurological status after surgical treatment according to the examination of neurologist
Oxygenation of the brainduring the surgical interventionaccording to transcranial oximetry
bleeding1 month30 days after surgery
Stenosis3rd dayThe percentage narrowing of the lumen at the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound
The linear flow velocity in the region of the carotid artery bifurcation3rd dayThe linear velocity of blood flow in the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026