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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04255316
Other study ID # 23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date March 1, 2020

Study information

Verified date January 2020
Source Pirogov Russian National Research Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date March 1, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Standard method of eversion carotid endarterectomy
standard eversion technic

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary Assessment of total stroke rate assessment of the total stroke rate in patients undergoing intervention after 30 days 30 days
Primary Assessment of mortality rate assessment of the mortality rate in patients undergoing intervention after 30 days 30 days
Secondary Assessment of stroke frequency assessment of stroke frequency in patients undergoing intervention after 12 months 12 months
Secondary 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
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