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Hemodynamics and Autonomic and Cognitive Performance After Carotid Revascularization Procedures

NCT03493971 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-11-30

No results posted yet for this study

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.

Conditions

  • Carotid Artery Diseases

Interventions

PROCEDURE

Carotid revascularization performed using CAS

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

PROCEDURE

Carotid revascularization performed using CEA

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

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • University of Pavia

    collaborator OTHER

  • Ospedale San Donato

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-21
Primary Completion
2022-04-20
Completion
2023-11-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03493971 on ClinicalTrials.gov