Atherosclerosis Clinical Trial
Official title:
Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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