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Completed

NCT Number: NCT04255316

Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation

A prospective comparative randomized single-centre non-inferiority trial. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation

Moscow, 117997, Russia

About this study

Introduction. Performing eversion endarterectomy some difficulties arise. Firstly, it requires a great deal of coherence between the work of the surgeon and the first assistant, as well as a great experience of the latter. Secondly, in some cases, there are difficulties in visualizing the distal margin of the intima: in the absence of a rigid skeleton, the soft unchanged artery walls after removal of the plaque subside, making it difficult to visualize possible fragments of the intima. Thirdly, the cost of the error is high: with a random de-version, repeated eversion turns out to be impossible. It should be noted that the use of an eversion technique becomes difficult to implement, and sometimes impossible, with extended stenosis, since a very high allocation of the ICA is required, which increases the invasiveness of the operation and the difficulty of access. With prolonged stenosis, the carotid endarterectomy remains the option of choice. The modification used eversion carotid endarterectomy combines the advantages of both methods, and also eliminates the limitations of the carotid endarterectomy and eversion carotid endarterectomy.

The aim of study. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with stenosis of ICA 70-99% (ultrasound - NASCET and CT angiography)
  • patients with a extensive lesion of the ICA (plaque < 2 cm) by ultrasound - NASCET and CT angiography

Exclusion criteria

  • patients with a extensive lesion of the ICA (plaque < 2 cm),
  • patients with a contralateral occlusion of the ICA
  • patients with stroke in ischemic type in the acute period.

Treatment and study plan

Modified method of eversion carotid endarterectomy

Procedure

Mini approach for CCA bifurcation - Clamping ICA, ECA and CCA - ICA is cut off with a scalpel at the mouth itself - Dissection of the ICA and ECA in the distal direction to the distal border of the atherosclerotic plaque - Endarterectomy - Performing of a new bifurcation of the CCA with prolene 7/0

Standard method of eversion carotid endarterectomy

Procedure

standard eversion technic

Primary outcomes

  1. Assessment of total stroke rate

    Time frame: 30 days

    assessment of the total stroke rate in patients undergoing intervention after 30 days

  2. Assessment of mortality rate

    Time frame: 30 days

    assessment of the mortality rate in patients undergoing intervention after 30 days

Secondary outcomes

  1. Assessment of stroke frequency

    Time frame: 12 months

    assessment of stroke frequency in patients undergoing intervention after 12 months

  2. Assessment of the incidence of internal carotid artery restenosis

    Time frame: 3, 6, 12 months

    Assessment of the incidence of internal carotid artery restenosis after 3, 6 and 12 months

Other outcomes

  1. Evaluation of speed flow in carotid bifurcation by ultrasound duplex scan

    Time frame: 24 hours, 30 days, 3, 6 and 12 months

    Evaluation of speed flow, peak systolic velocity (cm/s) in common carotid artery, internal carotid artery and external carotid artery and their ratios using ultrasound duplex scan.

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Jan 15, 2021

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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