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

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255316
• Other study ID #: 23
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Carotid Stenosis

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