Clinical trial NCT04255316: Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation
Official title: Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Stenosis
Carotid Artery Diseases
Keywords: carotid endarterectomy
eversion carotid endarterectomy
prophylaxis of ischemic stroke
carotid arteriosclerosis
carotid artery plasty
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of total stroke rate
timeFrame: 30 days
measure: Assessment of mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: Assessment of stroke frequency
timeFrame: 12 months
measure: Assessment of the incidence of internal carotid artery restenosis
timeFrame: 3, 6, 12 months
Other outcomes:
measure: Evaluation of speed flow in carotid bifurcation by ultrasound duplex scan
timeFrame: 24 hours, 30 days, 3, 6 and 12 months
Locations:
city: Moscow
country: Russian Federation
facility: The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Study officials:
affiliation: The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov
name: Anatoly Virgansky, MD
role: PRINCIPAL_INVESTIGATOR
References: