CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Carotid revascularization performed using CAS +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03493971
NCT03493971N/ACompleted

Impact of Carotid Endarterectomy and Stenting on Hemodynamics, Fluid-structure Interaction, Autonomic Modulation, and Cognitive Brain Function

Ospedale San Donato·interventional·Posted Apr 11, 2018·Updated Nov 30, 2023

In Brief

A clinical study evaluating Carotid revascularization performed using CAS and Carotid revascularization performed using CEA for Carotid Artery Diseases. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Carotid revascularization procedures are performed for more than 87% of cases in patients with asymptomatic internal carotid stenosis (ICS), who are assumed to have a life expectancy of at least 5 years. Hence, the investigators aim to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in terms of long-term prognostic endpoints in patients with uneventful perioperative course. CEA and CAS, as a consequence of either surgical trauma or mechanical stimuli related to the compliance mismatch between the stented segment and the native artery, may perturb carotid baroreceptors function causing an impairment of cardiovascular autonomic control. Also, CEA and CAS result in different postoperative geometric features of carotid arteries that entail relevant modifications of rheological parameters, that may be associated with the risk of local complications. Finally, long-term and sustained cognitive benefits after CAS as compared to CEA are yet to be demonstrated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 11, 2018
Enrollment StartMar 21, 2018
Primary CompletionApr 20, 2022
Study CompletionNov 29, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.2 years ago

Interventions

Carotid revascularization performed using CASprocedure

Carotid artery stenting (CAS) is an endovascular stent procedure used to treat narrowing of the carotid artery and decrease the risk of stroke

Carotid revascularization performed using CEAprocedure

Carotid endarterectomy (CEA) is a surgical procedure used to correct stenosis in the common carotid artery or internal carotid artery and reduce the risk of stroke