Carotid Endarterectomy and Carotid Artery Stenting in Brazil
NCT ID: NCT02538276
Last Updated: 2017-05-03
Study Results
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Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2013-07-31
2019-07-31
Brief Summary
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Detailed Description
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1. any in-hospital stroke.
2. any stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS.
The characteristics and background of patients who underwent CAS and CEA include: age, gender, carotid endarterectomy high risk; also presentation of symptoms, and degree of stenosis will be analyzed. Next, procedural success, periprocedural antiplatelet use, embolic protection device use, the type of stent (open-cell or closed-cell) or patch to carotid, the execution of pre ballooning or post ballooning dilatation at carotid artery stenting, and procedure-related complications will be analyzed to clarify the current strategy and the treatment results of both techniques . Degree of stenosis have been measured in accordance with North American Symptomatic Carotid Endarterectomy Trial method.
Outcomes will be stratified by symptomatic and asymptomatic status. Symptomatic patients are defined as having a neurologic event, including any hemispheric or ocular transient ischemic attack,major or minor stroke preceding the intervention ipsilateral to the treated lesion. Technical success relates to periprocedural events that occur from the initiation of the procedure and extend through the first 24-hour postoperative period. Primary technical success was defined on an intent-to-treat basis, and it will requires the successful exclusion of the carotid plaque by surgical or interventional means. Technical success include the outcomes and complications of preoperative carotid angiograms whenever these imaging studies are obtained prior to the carotid intervention. For carotid endarterectomy, primary technical success implies a successful removal of the carotid plaque and closure of the artery with or without patch and less than a 30% residual stenosis. For carotid stenting, the introduction and deployment of the embolic protection device and the carotid stent in the absence of stroke, myocardial infarction, death, surgical conversion, or vascular obstruction constitutes primary technical success.
All complications should be categorized as local vascular, local nonvascular, and systemic. Other complications. As with any vascular procedures, complications after carotid interventions should be reported in a systematic and standardized manner with a description of the degrees of severity. Although assigning a degree of severity to all complications of different methods of treatment may be difficult, severity scales should be provided whenever possible so adverse events can be assessed and compared. The following severity scale has been modified from the reporting standards for lower extremity ischemia:Mild (1) refers to a complication that resolves spontaneously or with minimal intervention, does not increase the hospital length of stay, and does not cause permanent disability. Moderate (2) refers to the need for significant intervention, prolongation of hospitalization more than 24 hours, and at most, minor permanent disability that does not interfere with normal daily activity. A severe complication (3) needs major surgical, endovascular or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group carotid endarterectomy (CEA)
Patients submitted to carotid endarterectomy
No interventions assigned to this group
Group carotid stenting (CAS)
Patients submitted to carotid artery stenting
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Edwaldo Edner Joviliano
MD; PhD
Principal Investigators
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EDWALDO E JOVILIANO, MD; PHD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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University Hospital of Botucatu Medical School
Botucatu, São Paulo, Brazil
University Hospital of School of Medical Sciences UNICAMP
Campinas, São Paulo, Brazil
University Hospital of Marilia Medical School
Marília, São Paulo, Brazil
University Hospital of Ribeirao Preto Medical School, University of São Paulo
Ribeirão Preto, São Paulo, Brazil
University Hospital of São Jose do Rio Preto Medical School
São José do Rio Preto, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Joviliano EE, Ribeiro MS, Sobreira ML, Moura R, Geiger MA, Guillamon AT, Regina de Oliveira Raymundo S, Miquelin DG, Hafner L, Almeida MJ, Oliveira TF, Dalio MB, Yoshida WB. Short-Term Outcomes of Transfemoral Carotid Artery Stenting and Carotid Endarterectomy in Symptomatic Patients: Data from a Multicentric Prospective Registry in Brazil. Ann Vasc Surg. 2022 Sep;85:41-48. doi: 10.1016/j.avsg.2022.04.053. Epub 2022 May 16.
Joviliano EE, Yoshida WB, Sobreira ML, Moura R, Guillaumon AT, Raymundo SR, Miquelin DG, Hafner L, Almeida MJ. An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol. JMIR Res Protoc. 2016 Nov 23;5(4):e226. doi: 10.2196/resprot.5986.
Other Identifiers
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01/2013
Identifier Type: -
Identifier Source: org_study_id
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