Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Carotid Endarterectomy and Carotid Artery Stenting in Brazil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02538276
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Edwaldo Edner Joviliano, University of Sao Paulo

Brief Summary:
Cerebrovascular disease is a leading cause of death and the leading cause of serious long-term disability. Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease.The safety and efficacy of CAS compared to CEA still remains questioned, and CEA has been considered to the first-line treatment of carotid stenosis in worldwide. The purpose of this study is to compare the practice and outcomes of CAS and CEA in a real world setting at Public University Hospitals in Brazil.

Condition or disease
Arterial Diseases, Carotid

Detailed Description:

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:

  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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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/Cohort
Group carotid endarterectomy (CEA)
Patients submitted to carotid endarterectomy
Group carotid stenting (CAS)
Patients submitted to carotid artery stenting



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who underwent to carotid endarterectomy (CEA)or carotida artery stenting(CAS) for treat carotid stenosis at the any of the five hospitals involved in the study.
Criteria

Inclusion Criteria:

  • Patients with carotid stenosis > 70% who wil be underwent to carotid endarterectomy or carotid artery stenting.

Exclusion Criteria:

  • Need to concomitant cardiac surgery.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Edwaldo E Joviliano, MD; PhD 5516981375511 eejoviliano@gmail.com
Contact: Winston B Yoshida, MD; PhD 5514997983664 jvascbr.ed@gmail.com

Locations
Layout table for location information
Brazil
University Hospital of Botucatu Medical School Recruiting
Botucatu, Sao Paulo, Brazil, 18607621
Contact: Winston B Yoshida, MD; PhD    551638116269    jvascbr.ed@gmail.com   
Contact: Marcone L Sobreira, MD; PhD    551438116269    mlsobreira@gmail.com   
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    eejoviliano@gmail.com   
Contact: Winston B Yoshida, MD; PhD    551438116269    jvascbr.ed@gmail.com   
University Hospital of School of Medical Sciences UNICAMP Recruiting
Campinas, São Paulo, Brazil, 13083888
Contact: Ana T Guillaumon, MD; PhD    5519981849370    anaterezinha.guillaumon@gmail.com   
University Hospital of Marilia Medical School Recruiting
Marilia, São Paulo, Brazil, 17519030
Contact: Marcelo J Almeida, MD; PhD    5514996012417    mjalmeida13@gmail.com   
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    selma.raymundo@gmail.com   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Layout table for investigator information
Principal Investigator: EDWALDO E JOVILIANO, MD; PHD University of Sao Paulo

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Edwaldo Edner Joviliano, MD; PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02538276     History of Changes
Other Study ID Numbers: 01/2013
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Edwaldo Edner Joviliano, University of Sao Paulo:
carotid endarterectomy, carotid stenosis, carotid stenting

Additional relevant MeSH terms:
Layout table for MeSH terms
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases