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
  Purpose

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.

Condition Intervention Phase
Transient Ischemic Attack
Carotid Stenosis
Atherosclerosis
Device: Carotid angioplasty and stenting with cerebral protection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 900
Study Start Date: November 2000
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Carotid angioplasty and stenting with cerebral protection
Device: Carotid angioplasty and stenting with cerebral protection
Carotid angioplasty and stenting with cerebral protection
Other Name: Carotid angioplasty and stenting with cerebral protection

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190398

Locations
France
Sainte-Anne Hospital: Department of Neurology
Paris, Ile de France, France, 75674 cedex14
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Louis MAS, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cecile jourdain, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00190398     History of Changes
Other Study ID Numbers: P990402
Study First Received: September 14, 2005
Last Updated: April 29, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prospective
Randomised
Open
Blinded End-point
PROBE Study
Ischemic stroke

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Carotid Stenosis
Ischemic Attack, Transient
Constriction, Pathologic
Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Ischemia
Pathological Conditions, Anatomical
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014