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SPREAD-STACI study: A protocol for a randomized multicenter clinical trial comparing urgent with delayed endarterectomy in symptomatic carotid artery stenosis.
MedLine Citation:
PMID:  22151469     Owner:  NLM     Status:  Publisher    
RATIONALE: In patients with >50% carotid artery stenosis (as measured by North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria) suffering a transient ischemic attack or a minor ipsilateral stroke, carotid endarterectomy exerts maximum benefits, when performed within the first 15 days from the initial ischemic symptom. It is also known that the probability of a major stroke spikes within the first few days after a transient ischemic attack/minor stroke and then flattens out in the following days and weeks. It could be hypothesized that urgent carotid endarterectomy has greater benefit than delayed procedure. AIMS: Demonstrate that urgent carotid endarterectomy is more effective than delayed interventions. DESIGN: Centers employing neurolgist/stroke physicians and vascular surgeons will enroll TIA or minor stroke patients with >50 % carotid artery stenosis (Nascet criteria), randomized in two groups: urgent carotid endarterectomy (within 48 hours) and delayed carotid endarterectomy ( operated between 48 hours and 15 days after onset of symptoms) Risk factors will be evaluated at enrollment. TIA will be classified by ABCD2 scoring system,and minor stroke by National Institutes of Health Stroke Scale (NIHSS) scores. The study will last 90 days per patient,starting from their initial symptom,and the follow-up will be performed by an indipendent neurologist. A total of 456 patients (228 / group) is needed to observe an absolute difference of 10% between groups. OUTCOMES: Primary end-point is reduction in all types of stroke, AMI or death in urgent endarterectomy groupo compared to delayed ones. Secondary end-points are: Reduction of ipsilateral ischemic stroke in group 1 with respect to Group 2 Identification of predictive risk factors and Confirmation of no different rate for hemorragic/ischemiccomplications between groups.
Gaetano Lanza; Stefano Ricci; Francesco Speziale; Danilo Toni; Enrico Sbarigia; Carlo Setacci; Carlo Pratesi; Francesco Somalvico; Augusto Zaninelli; Gian Franco Gensini
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-12-8
Journal Detail:
Title:  International journal of stroke : official journal of the International Stroke Society     Volume:  -     ISSN:  1747-4949     ISO Abbreviation:  -     Publication Date:  2011 Dec 
Date Detail:
Created Date:  2011-12-13     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101274068     Medline TA:  Int J Stroke     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2011 The Authors. International Journal of Stroke © 2011 World Stroke Organization.
Vascular Surgery Department, IRCCS MultiMedica Hospital, Castellanza, Italy.
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