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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified eversion | Experimental | Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a modified eversion carotid endarterectomy |
|
| Standard eversion | Active Comparator | Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a standard eversion carotid endarterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified method of eversion carotid endarterectomy | Procedure | 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 |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anatoly Virgansky, MD | The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation | Moscow | 117997 | Russia |
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|
| Standard method of eversion carotid endarterectomy | Procedure | standard eversion technic |
|
Assessment of the incidence of internal carotid artery restenosis after 3, 6 and 12 months
| 3, 6, 12 months |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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