Carotid Endarterectomy and Carotid Artery Stenting in Brazil

May 1, 2017 updated by: Edwaldo Edner Joviliano, University of Sao Paulo

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Ribeirao Preto, SP, Brazil, 14090042
        • Recruiting
        • University Hospital of Ribeirao Preto Medical School, University of São Paulo
        • Contact:
        • Contact:
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18607621
        • Recruiting
        • University Hospital of Botucatu Medical School
        • Contact:
        • Contact:
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083888
        • Recruiting
        • University Hospital of School of Medical Sciences UNICAMP
        • Contact:
      • Marilia, São Paulo, Brazil, 17519030
        • Recruiting
        • University Hospital of Marilia Medical School
        • Contact:
      • Sao Jose do Rio Preto, São Paulo, Brazil, 15090000
        • Recruiting
        • University Hospital of São Jose do Rio Preto Medical School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group carotid endarterectomy (CEA)
Patients submitted to carotid endarterectomy
Group carotid stenting (CAS)
Patients submitted to carotid artery stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30-day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
30-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: EDWALDO E JOVILIANO, MD; PHD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arterial Diseases, Carotid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe