Endarterectomy vs. Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) Trial.
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 angio-plasty. Carotid surgery is performed using standard operative techniques. Carotid angioplasty consists of pri-mary stenting with cerebral protection. The primary end-points 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 avascular neurologist, a vascular surgeon and an interventionalist. Operator experience must be substantiated through documentation of a sufficient number of cases performed.
D017130:Angioplasty / Q000009:adverse effects; D016893:Carotid Stenosis / Q000150:complications / Q000601:surgery*; D016894:Endarterectomy, Carotid / Q000009:adverse effects; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012720:Severity of Illness Index; D016037:Single-Blind Method