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.
- Endarterectomy, carotid (CEA)Procedure/Surgery
Intervention Desc: Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
- Angioplasty, carotid Procedure/Surgery
Intervention Desc: Intravascular procedure to dilate stenotic carotid arteries.
- Stent, carotid Procedure/Surgery
Intervention Desc: Intravascular procedure to maintain carotid artery patency
- Carotid angioplasty and stenting with cerebral protection Device
Other Names: Carotid angioplasty and stenting with cerebral protection Intervention Desc: Carotid angioplasty and stenting with cerebral protection ARM 1: Kind: Experimental Label: 1 Description: Carotid angioplasty and stenting with cerebral protection
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Eligible patients will be randomized to undergo either carotid endarterectomy or angioplasty with stenting. Angioplasty patients will receive either ticlopidine or clopidogrel for 1 month after the procedure. Patients in both groups will receive follow-up visits at 1 month, 6 months, and every 6 months thereafter for 2 - 4 years. Duplex scans will be performed at the time of the procedure, and every 6 months for the duration of the study. Patients in the angioplasty group will undergo blood draws at 15 days and 1 month, and a simple cervical radiogram at 2 years after the procedure.
|Type||Measure||Time Frame||Safety Issue|
|Primary||All mortality and all recurrence of stroke within 30 days, all ipsilateral stroke within 2 - 4 years.|
|Secondary||Incidence of myocardial infarction, transient ischemic attack (TIA), cranial nerve palsy, or any other regional complications within 30 days, incidence of TIA within 2-4 years, functional status at the end of the study, degree of carotid restenosis, as measured on carotid ultrasound, integrity of the stent at 2 years, as measured by cervical radiogram, duration of hospital stay.|
|Primary||Any stroke or death within 30 days of the procedure||during de study||Yes|
|Secondary||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])||during the study||Yes|
|Secondary||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||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||during the study||Yes|
|Secondary||TIA during the follow-up period||during the study||Yes|
|Secondary||Functional status at the end of the study||during the study||Yes|
|Secondary||Anatomical: Carotid restenosis (> 70% on carotid ultrasound)||during the study||Yes|
|Secondary||Integrity of the stent 2 years after the procedure (on cervical radiogram)||during the study||Yes|