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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
900
Carotid angioplasty and stenting with cerebral protection
Sainte-Anne Hospital: Department of Neurology
Paris, Île-de-France Region, France
Any stroke or death within 30 days of the procedure
Any stroke or death within 30 days of the procedure
Time frame: during de study
Clinical: Myocardial infarction within 30 days of the procedure
Clinical: Myocardial infarction within 30 days of the procedure
Time frame: during the study
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 \[TIA\])
Time frame: during the study
locoregional (e.g. cranial nerve palsy, complications at the site of puncture)
locoregional (e.g. cranial nerve palsy, complications at the site of puncture)
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
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
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
Time frame: during the study
TIA during the follow-up period
TIA during the follow-up period
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Time frame: during the study
Functional status at the end of the study
Functional status at the end of the study
Time frame: during the study
Anatomical: Carotid restenosis (> 70% on carotid ultrasound)
Anatomical: Carotid restenosis (\> 70% on carotid ultrasound)
Time frame: during the study
Integrity of the stent 2 years after the procedure (on cervical radiogram)
Integrity of the stent 2 years after the procedure (on cervical radiogram)
Time frame: during the study