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

Study Overview

• Status: Completed
• Conditions: Carotid Stenosis; Carotid Artery Diseases
• Intervention / Treatment: Procedure: Modified method of eversion carotid endarterectomy; Procedure: Standard method of eversion carotid endarterectomy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 117997
    • The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified eversion; Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a modified eversion carotid endarterectomy	Procedure: Modified method of eversion carotid endarterectomy; 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
Active Comparator: Standard eversion; Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a standard eversion carotid endarterectomy	Procedure: Standard method of eversion carotid endarterectomy; standard eversion technic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of total stroke rate	assessment of the total stroke rate in patients undergoing intervention after 30 days	30 days
Assessment of mortality rate	assessment of the mortality rate in patients undergoing intervention after 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of stroke frequency	assessment of stroke frequency in patients undergoing intervention after 12 months	12 months
Assessment of the incidence of internal carotid artery restenosis	Assessment of the incidence of internal carotid artery restenosis after 3, 6 and 12 months	3, 6, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of speed flow in carotid bifurcation by ultrasound duplex scan	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.	24 hours, 30 days, 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University
• Investigators: Principal Investigator: Anatoly Virgansky, MD, The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: carotid endarterectomy; eversion carotid endarterectomy; prophylaxis of ischemic stroke; carotid arteriosclerosis; carotid artery plasty
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Stenosis; Carotid Artery Diseases
• Other Study ID Numbers: 23 (SIME)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No