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

Pirogov Russian National Research Medical University

Status: Completed

Conditions: Carotid Stenosis; Carotid Artery Diseases

Treatments: Procedure: Standard method of eversion carotid endarterectomy; Procedure: Modified method of eversion carotid endarterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04255316

23

Details and patient eligibility

About

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

Full 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

Enrollment: 126 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Modified eversion

Experimental group

Description:

Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a modified eversion carotid endarterectomy

Treatment:

Procedure: Modified method of eversion carotid endarterectomy

Standard eversion

Active Comparator group

Description:

Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a standard eversion carotid endarterectomy

Treatment:

Procedure: Standard method of eversion carotid endarterectomy