The Role of Maintaining External Carotid Artery Flow in Graft Interposition After Carotid Endarterectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-90
SponsorInstitute for Cardiovascular Diseases Dedinje

About this trial

Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

symptomatic carotid stenosis (> 50%)

unilateral asymptomatic carotid stenosis (> 60%)

bilateral asymptomatic carotid stenosis (> 60%)

Disqualifiers

carotid restenosis

"major surgery" in previous 6 months

previous brain trauma or surgery

malignant disease

Trial population

Patients who underwent carotid artery surgery due to atherosclerotic symptomatic and asymptomatic disease had graft interposition conducted due to unsuccessful endarterectomy.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Carotid graft interposition

    Procedure/Surgery

    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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: ECA flow preserved group1 intervention
Group B: Ligated ECA group1 intervention

Trial outcomes

Primary outcomes

1

periprocedural stroke and death

onset of new neurological deficit or death during perioperative period

Time frame
30 days
2

myocardial infarction

development of new acute coronary events during perioperative period

Time frame
30 days
3

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

Secondary outcomes

1

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
2

graft patency

primary and primary assisted

Time frame
through study completion, an average of 2 years
3

patient survival

defining cause of death

Time frame
through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

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