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Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.
Surgical and endovascular treatment have been shown as effective treatment modalities in symptomatic and asymptomatic patients at high risk of stroke on medical therapy with significant carotid artery stenosis. Eversion carotid endarterectomy (eCEA) has proven effective as a surgical treatment modality. In highly selected instances carotid bypass may be indicated as a bailout procedure or primarily as a preoperatively planned maneuver. Usually, the decision for substitution of carotid bifurcation with a synthetic graft is made due to an extensive, severe atherosclerotic process on the distal part of the extracranial internal carotid artery, the presence of uncontrollable atherosclerotic plaque after endarterectomy, and in cases when an exceptionally thin artery wall remains after endarterectomy.
Several techniques have been described for substituting carotid bifurcation with a synthetic graft. The most common technique involves complete resection and excision of the carotid bifurcation and reconstruction with graft interposition between the undiseased segment of the common carotid artery (CCA) proximally and the internal carotid artery (ICA) distally by creating proximal and distal end-to-end anastomoses. This technique requires ligation and exclusion of the external carotid (ECA) and the superior thyroid artery from circulation. The less common techniques that preserve flow through the external carotid artery are performed as a primary option for treatment without previous endarterectomy and are seldom applied. Currently, there are no recommendations regarding the administration of carotid bypass, nor comparisons of these techniques.
In this study, the investigators are comparing a technique with graft interposition between endarterectomized CCA (creation of side-to-end anastomosis) and the distal segment of the ICA (end-to-end anastomosis) after failure of eCEA to provide technical success with the described common interposition by end-to-end anastomoses proximally and distally. Therefore, the role of flow preservation through the ECA could be defined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECA flow preserved group | Patients with carotid graft interposition after endarterectomy of the common carotid artery and external carotid artery with preserved flow through the external carotid artery by side-to-end proximal anastomosis. |
| |
| Ligated ECA group | Patients with carotid graft interposition and end-to-end anastomoses on the undiseased segments of the common (proximally) and internal (distally) carotid artery, with ligation of the external carotid artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid graft interposition | Procedure | In patients with extensive atherosclerotic carotid disease, when endarterectomy isn't feasible, replacement of the carotid artery with a graft is needed. Graft interposition can be performed either by end-to-end proximal and distal anastomoses in the undiseased common and internal carotid artery with ligation of the external carotid artery, or by side-to-end proximal anastomosis on the origin of the internal carotid artery and end-to-end distal anastomosis on the internal carotid artery with flow preservation in the external carotid artery. |
| Measure | Description | Time Frame |
|---|---|---|
| periprocedural stroke and death | onset of new neurological deficit or death during perioperative period | 30 days |
| myocardial infarction | development of new acute coronary events during perioperative period | 30 days |
| stroke ipsilateral to the procedure | development of new neurological events that are pathophysiological atributable to the operated side | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| restenosis rate | restenosis after graft placement diagnosed by color Doppler sonographic examination or by multiplanar detection computerized tomography angiography | through study completion, an average of 2 years |
| graft patency |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent carotid artery surgery due to atherosclerotic symptomatic and asymptomatic disease had graft interposition conducted due to unsuccessful endarterectomy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Slobodan Pesic, MD | Contact | 00381616303360 | spesic90@gmail.com | |
| Jovan Petrovic, MD | Contact | jovanpetrovic1997@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Srdjan Babic, MD PhD | Institute for Cardiovascular Diseases Dedinje | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Cardiovascular Diseases Dedinje | Recruiting | Belgrade | 11000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21609800 | Background | Timaran CH, McKinsey JF, Schneider PA, Littooy F. Reporting standards for carotid interventions from the Society for Vascular Surgery. J Vasc Surg. 2011 Jun;53(6):1679-95. doi: 10.1016/j.jvs.2010.11.122. No abstract available. |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
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primary and primary assisted
| through study completion, an average of 2 years |
| patient survival | defining cause of death | through study completion, an average of 2 years |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |