Document Detail


Multicenter experience with a new "hybrid" carotid stent.
MedLine Citation:
PMID:  18426267     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: To report the results from a prospective multicenter registry evaluating the safety and performance of a new hybrid stent specifically engineered for carotid indications. METHODS: Between October 18, 2006, and March 28, 2007, 124 patients (88 men; mean age 71.8+/-7.3 years, range 52-87) underwent Cristallo Ideale stent implantation at 4 expert sites in Italy and Germany. Eligibility criteria included >60% symptomatic and >80% asymptomatic carotid stenosis. Different cerebral protection devices were utilized (proximal protection and distal filters). The primary endpoint was the rate of 30-day major adverse neurological events, defined as major and minor stroke and neurological death by independent neurological assessment. All adverse events were adjudicated by an independent clinical event committee. RESULTS: Stent deployment was completed successfully in all the cases without documented technical failure. There were no neurological events during the procedures. Thirty-day follow-up was available for 119 (96.0%) patients [2 (1.6%) were lost to follow-up and 3 (2.4%) died from non-neurological causes unrelated to the device or procedure]. There were no major adverse neurological events within 30 days, but 2 (1.6%) device-/procedure-related transient ischemic attacks were reported (both resolved completely in <24 hours). Four (3.2%) other non-neurological events (anemia requiring transfusion, worsening of pre-existing chronic renal failure, acute access site thrombosis, and monocular vision disturbance) were reported in the study period. CONCLUSION: The Cristallo Ideale carotid stent is safe and effective in the periprocedural period. Its newly designed hybrid structure seems to support the rationale of combining adequate plaque scaffolding with high vessel adaptability.
Authors:
Alberto Cremonesi; Paolo Rubino; Chiara Grattoni; Dierk Scheinert; Fausto Castriota; Giancarlo Biamino
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Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists     Volume:  15     ISSN:  1526-6028     ISO Abbreviation:  J. Endovasc. Ther.     Publication Date:  2008 Apr 
Date Detail:
Created Date:  2008-04-22     Completed Date:  2008-09-04     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100896915     Medline TA:  J Endovasc Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  186-92     Citation Subset:  IM    
Affiliation:
Interventional Cardiovascular Unit, Villa Maria Cecilia Hospital, Cotignola, Italy. acremonesi@gvm-vmc.it
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Alloys
Carotid Stenosis / surgery*
Female
Humans
Male
Middle Aged
Prospective Studies
Prosthesis Design
Registries
Safety
Stents*
Stroke / prevention & control
Treatment Outcome
Chemical
Reg. No./Substance:
0/Alloys; 52013-44-2/nitinol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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