An observational study in Carotid Artery Diseases, Stroke and Carotid Atherosclerosis, sponsored by Institute for Cardiovascular Diseases Dedinje. Recruiting at 1 site in Serbia. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Institute for Cardiovascular Diseases Dedinje · Observational
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.
248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.
This study's planned enrollment of 250 is above the median of 224 across 108 observational studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →Institute for Cardiovascular Diseases Dedinje is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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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.
Exclusion Criteria:
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.
Procedure: Carotid graft interposition
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.
Procedure: Carotid graft interposition
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.
Also known as: Carotid artery graft replacement, Carotid replacement with Dacron graft
periprocedural stroke and death
onset of new neurological deficit or death during perioperative period
Time frame: 30 days
myocardial infarction
development of new acute coronary events during perioperative period
Time frame: 30 days
stroke ipsilateral to the procedure
development of new neurological events that are pathophysiological atributable to the operated side
Time frame: through study completion, an average of 2 years
restenosis rate
restenosis after graft placement diagnosed by color Doppler sonographic examination or by multiplanar detection computerized tomography angiography
Time frame: through study completion, an average of 2 years
graft patency
primary and primary assisted
Time frame: through study completion, an average of 2 years
patient survival
defining cause of death
Time frame: through study completion, an average of 2 years
Plan to share: No
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Institute for Cardiovascular Diseases Dedinje