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EVA3S: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

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ClinicalTrials.gov Identifier: NCT00190398
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 2, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date May 2, 2011
Study Start Date  ICMJE November 2000
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
Any stroke or death within 30 days of the procedure [ Time Frame: during de study ]
Any stroke or death within 30 days of the procedure
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • - Any stroke or death within 30 days of the procedure
  • - Any stroke or death within 30 days of the procedure plus ipsilateral stroke during the follow-up period (2 to 4 years).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
  • Clinical: Myocardial infarction within 30 days of the procedure [ Time Frame: during the study ]
    Clinical: Myocardial infarction within 30 days of the procedure
  • Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA]) [ Time Frame: during the study ]
    Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA])
  • locoregional (e.g. cranial nerve palsy, complications at the site of puncture) [ Time Frame: during the study ]
    locoregional (e.g. cranial nerve palsy, complications at the site of puncture)
  • General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period [ Time Frame: during the study ]
    General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period
  • Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up period [ Time Frame: during the study ]
    Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up period
  • TIA during the follow-up period [ Time Frame: during the study ]
    TIA during the follow-up period
  • Functional status at the end of the study [ Time Frame: during the study ]
    Functional status at the end of the study
  • Anatomical: Carotid restenosis (> 70% on carotid ultrasound) [ Time Frame: during the study ]
    Anatomical: Carotid restenosis (> 70% on carotid ultrasound)
  • Integrity of the stent 2 years after the procedure (on cervical radiogram) [ Time Frame: during the study ]
    Integrity of the stent 2 years after the procedure (on cervical radiogram)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • Clinical
  • · Myocardial infarction within 30 days of the procedure.
  • · Other complications within 30 days of the procedure: cerebral (TIA); locoregional (e.g. cranial nerve palsy, complications at the site of punction); general.
  • · Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period. Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up peri
  • · TIA during the follow-up period.
  • · Functional status at the end of the study.q Anatomical
  • · Carotid restenosis (> 70% on carotid ultrasound).
  • · Integrity of the stent 2 years after the procedure (on cervical radiogram).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EVA3S: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis
Official Title  ICMJE Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis
Brief Summary

The purpose of this study is to evaluate whether carotid angioplasty with stent (CAS) is as safe and effective as carotid surgery in regards to:

  1. the risk of stroke and death within 30 days of the procedure;
  2. the long-term risk of ipsilateral carotid territory stroke, in patients with recently symptomatic, severe carotid stenosis suitable for both CAS and carotid endarterectomy.
Detailed Description

Findings from two large randomized clinical trials - NASCET and ECST - have established endarterectomy as the standard treatment for severe symptomatic carotid artery stenosis. Compared to endarterectomy, stenting with or without cerebral protection has the advantage of avoiding general anesthesia and incision in the neck that could lead to nerve injury and wound complications. The costs may be less than those of surgery, mainly because of a shorter hospital stay. However, stenting also carries a risk of stroke and local complications. Unlike endarterectomy, which has known long-term benefits, stenting does not remove the atheromatous plaque, and the long-term efficacy of this technique needs also to be assessed. Several trials are in progress in Europe and the United States.

We established this trial to evaluate whether stenting is not inferior to endarterectomy concerning (a) the risk of stroke or death within 30 days of procedure and (b) the long-term risk of ipsilateral stroke, in patients with recently symptomatic, severe carotid stenosis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Transient Ischemic Attack
  • Carotid Stenosis
  • Atherosclerosis
Intervention  ICMJE Device: Carotid angioplasty and stenting with cerebral protection
Carotid angioplasty and stenting with cerebral protection
Study Arms  ICMJE Experimental: 1
Carotid angioplasty and stenting with cerebral protection
Intervention: Device: Carotid angioplasty and stenting with cerebral protection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2005)
900
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • In brief, patients are eligible if they have experienced a carotid TIA or non disabling stroke within 4 months before randomisation and if they have an atherosclerotic stenosis of the region of the ipsilateral carotid bifurcation of 60% or more, as determined by the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method, that investigators believe is suitable for both carotid endarterectomy and endovascular treatment. The degree of stenosis warranting treatment initially set at 70% or more was subsequently set at 60% or greater to reflect current generally accepted practice in the treatment of symptomatic carotid stenosis. The presence of a 60% or more ipsilateral carotid stenosis has to be confirmed by conventional digital subtraction angiography or the combination of carotid Duplex scanning and magnetic resonance angiography, provided the results of these non-invasive techniques are concordant.

Exclusion Criteria:

  • Patients cannot be included if they have a disabling stroke (mRS >=3), a non atherosclerotic carotid disease, a severe intracranial carotid artery stenosis, contra-indications to heparin, ticlopidine or clopidogrel.
  • There is no age limit.
  • The presence of contralateral occlusion and/or the angiographic appearance of the stenotic lesion are not factors in treatment selection. The randomisation algorithm takes centre and degree of stenosis (more or less than 90% stenosis) into account. Patients must be treated as soon as possible after random assignment, in any case within 2 weeks of randomisation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00190398
Other Study ID Numbers  ICMJE P990402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cecile jourdain, Department Clinical Research of developpement
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Louis MAS, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP