Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02538276 |
| Other study ID # |
01/2013 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
August 24, 2015 |
| Last updated |
May 1, 2017 |
| Start date |
July 2013 |
| Est. completion date |
July 2019 |
Study information
| Verified date |
May 2017 |
| Source |
University of Sao Paulo |
| Contact |
Edwaldo E Joviliano, MD; PhD |
| Phone |
5516981375511 |
| Email |
eejoviliano[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
