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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190398
First received: September 14, 2005
Last updated: April 29, 2011
Last verified: February 2007

September 14, 2005
April 29, 2011
November 2000
December 2009   (final data collection date for primary outcome measure)
Any stroke or death within 30 days of the procedure [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
Any stroke or death within 30 days of the procedure
  • - 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).
Complete list of historical versions of study NCT00190398 on ClinicalTrials.gov Archive Site
  • Clinical: Myocardial infarction within 30 days of the procedure [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    TIA during the follow-up period
  • Functional status at the end of the study [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Functional status at the end of the study
  • Anatomical: Carotid restenosis (> 70% on carotid ultrasound) [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Anatomical: Carotid restenosis (> 70% on carotid ultrasound)
  • Integrity of the stent 2 years after the procedure (on cervical radiogram) [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Integrity of the stent 2 years after the procedure (on cervical radiogram)
  • 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).
Not Provided
Not Provided
 
EVA3S: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis
Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Transient Ischemic Attack
  • Carotid Stenosis
  • Atherosclerosis
Device: Carotid angioplasty and stenting with cerebral protection
Carotid angioplasty and stenting with cerebral protection
Other Name: Carotid angioplasty and stenting with cerebral protection
Experimental: 1
Carotid angioplasty and stenting with cerebral protection
Intervention: Device: Carotid angioplasty and stenting with cerebral protection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00190398
P990402
Yes
Cecile jourdain, Department Clinical Research of developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Jean-Louis MAS, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
February 2007

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