Institute for Cardiovascular Diseases Dedinje
Belgrade, 11000, Serbia
Location status: Recruiting
NCT Number: NCT06528717
Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.
Interested in participating?
Request Info50 year–90 year
All sexes
Observational
Belgrade, 11000, Serbia
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Carotid artery graft replacement, Carotid replacement with Dacron graft
Time frame: 30 days
onset of new neurological deficit or death during perioperative period
Time frame: 30 days
development of new acute coronary events during perioperative period
Time frame: through study completion, an average of 2 years
development of new neurological events that are pathophysiological atributable to the operated side
Time frame: through study completion, an average of 2 years
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
primary and primary assisted
Time frame: through study completion, an average of 2 years
defining cause of death
Contact information is provided by the study sponsor or research team.
Jovan Petrovic, MD
CONTACT
Slobodan Pesic, MD
CONTACT
Institute for Cardiovascular Diseases Dedinje
Other
Acronym: AGICS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05134493
Arterial Occlusive Diseases, Brain Diseases
Modena, Italy
View Trial DetailsNCT05800821
Arterial Occlusive Diseases, Brain Diseases
Minsk, Belarus
View Trial DetailsNCT06359756
Brain Diseases, Cardiovascular Diseases
Belgrade, Serbia
View Trial DetailsNCT03978988
Brain Diseases, Cardiovascular Diseases
Vandœuvre-lès-Nancy, France
View Trial Details