Carotid Endarterectomy and Carotid Artery Stenting in Brazil
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|ClinicalTrials.gov Identifier: NCT02538276|
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : May 3, 2017
|Condition or disease|
|Arterial Diseases, Carotid|
This study will be a prospective analysis of the treatment of patients with carotid stenosis through carotid endarterectomy and carotid artery stenting performed at 5 centers proposed by five years with the Vascular Study Group from public Universities of Sao Paulo state in Brazil. The primary outcome measures will be:
- any in-hospital stroke.
- 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Study of a Real-word Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil. Analysis of Prospective Cases of the Registry of Vascular Diseases at University Hospitals of the State of São Paulo|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2019|
Group carotid endarterectomy (CEA)
Patients submitted to carotid endarterectomy
Group carotid stenting (CAS)
Patients submitted to carotid artery stenting
- any stroke [ Time Frame: 30-day ]major or minor, ipsilateral or contralateral. Postoperative major strokes will be defined as cortical, vertebrobasilar, or ocular disability resulting in nonindependent living status, or blindness; otherwise strokes will be defined as minor
- any stroke, death or myocardial infarction [ Time Frame: 30-day ]major or minor, ipsilateral or contralateral for stroke, 30-day mortality and/or myocardial infarction confirmed by electrocardiogram and / or positive marker (Troponin).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538276
|Contact: Edwaldo E Joviliano, MD; PhDemail@example.com|
|Contact: Winston B Yoshida, MD; PhDfirstname.lastname@example.org|
|University Hospital of Botucatu Medical School||Recruiting|
|Botucatu, Sao Paulo, Brazil, 18607621|
|Contact: Winston B Yoshida, MD; PhD 551638116269 email@example.com|
|Contact: Marcone L Sobreira, MD; PhD 551438116269 firstname.lastname@example.org|
|University Hospital of Ribeirao Preto Medical School, University of São Paulo||Recruiting|
|Ribeirao Preto, SP, Brazil, 14090042|
|Contact: Edwaldo E Joviliano, MD; PhD 551636021000 ext 2406 email@example.com|
|Contact: Winston B Yoshida, MD; PhD 551438116269 firstname.lastname@example.org|
|University Hospital of School of Medical Sciences UNICAMP||Recruiting|
|Campinas, São Paulo, Brazil, 13083888|
|Contact: Ana T Guillaumon, MD; PhD 5519981849370 email@example.com|
|University Hospital of Marilia Medical School||Recruiting|
|Marilia, São Paulo, Brazil, 17519030|
|Contact: Marcelo J Almeida, MD; PhD 5514996012417 firstname.lastname@example.org|
|University Hospital of São Jose do Rio Preto Medical School||Recruiting|
|Sao Jose do Rio Preto, São Paulo, Brazil, 15090000|
|Contact: Selma R Raymundo, MD; PhD 5517996016062 email@example.com|
|Principal Investigator:||EDWALDO E JOVILIANO, MD; PHD||University of Sao Paulo|