Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) is a French multicenter, non-inferiority randomized trial with national research organisation funding. 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 NASCET method, that investigators believe is suitable for both carotid surgery and angioplasty. Carotid surgery is performed using standard operative techniques. Carotid angioplasty consists of primary stenting with cerebral protection. The primary endpoints are: (a) any stroke or death within 30 days of the procedure and (b) any stroke or death within 30 days of the procedure plus ipsilateral stroke. To join the study, a centre must form a multidisciplinary team, including a vascular neurologist, a vascular surgeon and an interventionalist. Operator experience must be substantiated through documentation of a sufficient number of cases performed.

Keywords:
Stroke, Transient ischaemic attack, Carotid, Endarterectomy, Angioplasty, Randomized clinical trial
1.
EVA-3S Investigators: Carotid angioplasty and stenting with and without cerebral protection. Clinical alert from the endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis (EVA-3S) trial. Stroke 2004;35:e18–e21.
2.
Blackwelder WC: Proving the null hypothesis in clinical trials. Control Clin Trials 1982;3:345–353.
© 2004 S. Karger AG, Basel
2004
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