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Completed

NCT Number: NCT03027752

Pilot Study of 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

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Key information

Conditions

Stenosis, Internal Carotid Artery Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Operation carotid endarterectomy with plastic of xenopericardial patch

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.

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

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.

Primary outcomes

  1. Stroke or TIA

    Time frame: throughout 1 year

    according to the examination of neurologist

Secondary outcomes

  1. Restenosis

    Time frame: 1 year

    The percentage narrowing of the lumen at the bifurcation of the carotid artery at 1 year after surgery according to the ultrasound

  2. Restenosis

    Time frame: 6 months

    The percentage narrowing of the lumen at the bifurcation of the carotid artery at 6 months after surgery according to the ultrasound

  3. paresis of the cranial nerve

    Time frame: up to 1 weeks

    Neurological status after surgical treatment according to the examination of neurologist

  4. The linear flow velocity in the region of the carotid artery bifurcation

    Time frame: 3rd day

    The linear velocity of blood flow in the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound

  5. The linear flow velocity in the region of the carotid artery bifurcation

    Time frame: 6 months

    The linear velocity of blood flow in the bifurcation of the carotid artery after 6 months according to the ultrasound

  6. The linear flow velocity in the region of the carotid artery bifurcation

    Time frame: 1 year

    The linear velocity of blood flow in the bifurcation of the carotid artery after 1 year according to the ultrasound

  7. bleeding

    Time frame: 1 month

    30 days after surgery

  8. Stenosis

    Time frame: 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

  9. Oxygenation of the brain

    Time frame: during the surgical intervention

    according to transcranial oximetry

  10. Oxygenation of the brain

    Time frame: 6 months

    according to transcranial oximetry

  11. Oxygenation of the brain

    Time frame: 1 year

    according to transcranial oximetry

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2017
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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