EVA3S: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis
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| ClinicalTrials.gov Identifier: NCT00190398 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : May 2, 2011
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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:
- the risk of stroke and death within 30 days of the procedure;
- 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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Transient Ischemic Attack Carotid Stenosis Atherosclerosis | Device: Carotid angioplasty and stenting with cerebral protection | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 900 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis |
| Study Start Date : | November 2000 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Carotid angioplasty and stenting with cerebral protection
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Device: Carotid angioplasty and stenting with cerebral protection
Carotid angioplasty and stenting with cerebral protection |
- 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
- 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190398
| France | |
| Sainte-Anne Hospital: Department of Neurology | |
| Paris, Ile de France, France, 75674 cedex14 | |
| Principal Investigator: | Jean-Louis MAS, Pr, MD, PhD | Assistance Publique - Hôpitaux de Paris |
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 |
| Other Study ID Numbers: |
P990402 |
| First Posted: | September 19, 2005 Key Record Dates |
| Last Update Posted: | May 2, 2011 |
| Last Verified: | February 2007 |
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Prospective Randomised Open |
Blinded End-point PROBE Study Ischemic stroke |
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Ischemic Attack, Transient Carotid Stenosis Atherosclerosis Constriction, Pathologic Pathological Conditions, Anatomical Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Carotid Artery Diseases |