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

Last updated: April 29, 2011
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

3

Condition

Carotid Artery Disease

Cardiac Ischemia

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT00190398
P990402
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • In brief, patients are eligible if they have experienced a carotid TIA or nondisabling stroke within 4 months before randomisation and if they have anatherosclerotic 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 carotidendarterectomy and endovascular treatment. The degree of stenosis warranting treatmentinitially set at 70% or more was subsequently set at 60% or greater to reflect currentgenerally accepted practice in the treatment of symptomatic carotid stenosis. Thepresence of a 60% or more ipsilateral carotid stenosis has to be confirmed byconventional digital subtraction angiography or the combination of carotid Duplexscanning and magnetic resonance angiography, provided the results of thesenon-invasive techniques are concordant.

Exclusion

Exclusion Criteria:

  • Patients cannot be included if they have a disabling stroke (mRS >=3), a nonatherosclerotic 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 thestenotic lesion are not factors in treatment selection. The randomisation algorithmtakes 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 casewithin 2 weeks of randomisation.

Study Design

Total Participants: 900
Study Start date:
November 01, 2000
Estimated Completion Date:
December 31, 2009

Study 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.

Connect with a study center

  • Sainte-Anne Hospital: Department of Neurology

    Paris, Ile de France 75674 cedex14
    France

    Site Not Available

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