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Comparison of two methods for revascularization of the bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carotid endarterectomy patch angioplasty | Active Comparator | Carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty |
|
| Carotid endarterectomy with autoarterial remodeling | Experimental | Carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operation carotid endarterectomy with plastic of xenopericardial patch | Procedure | Under local anesthesia Sol.Novocaini 0.25%, wires or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Common carotid artery cut then performed a longitudinal arteriotomy on the front of the anterior surface of the internal carotid artery. Under the visual control performs a sequence of endarterectomy of the internal carotid artery. Plastic arteriotomy performed patche of ksenoperikardial (Kemperiplas-Neo) treated with epoxy compounds. |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke or TIA | according to the examination of neurologist | throughout 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Restenosis | The percentage narrowing of the lumen at the bifurcation of the carotid artery at 1 year after surgery according to the ultrasound | 1 year |
| Restenosis | The percentage narrowing of the lumen at the bifurcation of the carotid artery at 6 months after surgery according to the ultrasound |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk Research Institute of Circulation Pathology | Novosibirsk | 630055 | Russia |
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| New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA | Procedure | Under local anesthesia Sol.Novocaini 0.25%, or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Carotid glomus separated and moves downward and backward bifurcation of the common carotid artery. External carotid artery is cut off at an angle of 45º from the mouth with a portion of the common carotid artery, then performed a longitudinal arteriotomy on the front of the medial surface of the internal carotid and posterior-lateral surface of the external carotid artery. Under the visual control performs a sequence of endarterectomy of the internal and external carotid arteries. The final recovery of the arteries is performed by crosslinking of their walls with each other in a side by side type between the internal and external carotid arteries 6/0 Polypropylene thread with two needles. |
|
| 6 months |
| paresis of the cranial nerve | Neurological status after surgical treatment according to the examination of neurologist | up to 1 weeks |
| The linear flow velocity in the region of the carotid artery bifurcation | The linear velocity of blood flow in the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound | 3rd day |
| The linear flow velocity in the region of the carotid artery bifurcation | The linear velocity of blood flow in the bifurcation of the carotid artery after 6 months according to the ultrasound | 6 months |
| The linear flow velocity in the region of the carotid artery bifurcation | The linear velocity of blood flow in the bifurcation of the carotid artery after 1 year according to the ultrasound | 1 year |
| bleeding | 30 days after surgery | 1 month |
| Stenosis | The percentage narrowing of the lumen at the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound | 3rd day |
| Oxygenation of the brain | according to transcranial oximetry | during the surgical intervention |
| Oxygenation of the brain | according to transcranial oximetry | 6 months |
| Oxygenation of the brain | according to transcranial oximetry | 1 year |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| 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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