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

Atherosclerosis Clinical Trial

Official title:

Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190398
• Other study ID #: P990402
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: April 29, 2011
• Start date: November 2000
• Est. completion date: December 2009

Study information

• Verified date: February 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Stenosis
• Constriction, Pathologic
• Ischemic Attack, Transient
• Transient Ischemic Attack

Intervention

Device:
• Carotid angioplasty and stenting with cerebral protection
Carotid angioplasty and stenting with cerebral protection

Locations

Country	Name	City	State
France	Sainte-Anne Hospital: Department of Neurology	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Mas JL, Chatellier G, Beyssen B, Branchereau A, Moulin T, Becquemin JP, Larrue V, Lièvre M, Leys D, Bonneville JF, Watelet J, Pruvo JP, Albucher JF, Viguier A, Piquet P, Garnier P, Viader F, Touzé E, Giroud M, Hosseini H, Pillet JC, Favrole P, Neau JP, Du — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any stroke or death within 30 days of the procedure	Any stroke or death within 30 days of the procedure	during de study	Yes
Secondary	Clinical: Myocardial infarction within 30 days of the procedure	Clinical: Myocardial infarction within 30 days of the procedure	during the study	Yes
Secondary	Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA])	Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA])	during the study	Yes
Secondary	locoregional (e.g. cranial nerve palsy, complications at the site of puncture)	locoregional (e.g. cranial nerve palsy, complications at the site of puncture)	during the study	Yes
Secondary	General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period	General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period	during the study	Yes
Secondary	Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) 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	during the study	Yes
Secondary	TIA during the follow-up period	TIA during the follow-up period	during the study	Yes
Secondary	Functional status at the end of the study	Functional status at the end of the study	during the study	Yes
Secondary	Anatomical: Carotid restenosis (> 70% on carotid ultrasound)	Anatomical: Carotid restenosis (> 70% on carotid ultrasound)	during the study	Yes
Secondary	Integrity of the stent 2 years after the procedure (on cervical radiogram)	Integrity of the stent 2 years after the procedure (on cervical radiogram)	during the study	Yes