Document Detail


EVIDENCE Trial: design of a phase 2, randomized, controlled, multicenter study comparing flow diversion and traditional endovascular strategy in unruptured saccular wide-necked intracranial aneurysms.
MedLine Citation:
PMID:  25280445     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
INTRODUCTION: Endovascular treatment of large, wide-necked intracranial aneurysms with coils is associated with low rates of initial angiographic occlusion and high rates of recurrence. The Pipeline™ Embolization Device has shown high rates of complete occlusion in uncontrolled clinical series.
METHODS: The study is a prospective, controlled, randomized, multicenter, phase 2 open-label trial. Intention-to-treat population includes age ≥18, unruptured saccular aneurysm located in the intra-dural area, neck diameter ≥4 and ≤10 mm, sac diameter ≥7 mm and ≤20 mm, "dome/neck" ratio is ≥1, diameter of the parent artery ≥2 mm and ≤5 mm, and no prior treatment of the aneurysm. Site can only participate if five patients have been previously treated with the Pipeline device. The primary end point of the study is complete occlusion of the aneurysm on angiogram performed 12 months after the endovascular procedure. Complete aneurysm occlusion is defined as the absence of visible blood flow, grade 1 according to the Raymond scale for the standard procedure group and grade 4 according to the grading scale of Kamran for the flow diverter group.
RESULTS: The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up.
CONCLUSION: This paper details the trial design of the French EVIDENCE phase 2 trial, a blinded, controlled randomized trial of wide-neck intra-dural aneurysms amenable to either traditional endovascular strategy or flow diversion with Pipeline device.
Authors:
Francis Turjman; Olivier Levrier; Xavier Combaz; Alain Bonafé; Alessandra Biondi; Hubert Desal; Serge Bracard; Charbel Mounayer; Roberto Riva; Francois Chapuis; Laure Huot; Xavier Armoiry; Benjamin Gory
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-10-4
Journal Detail:
Title:  Neuroradiology     Volume:  -     ISSN:  1432-1920     ISO Abbreviation:  Neuroradiology     Publication Date:  2014 Oct 
Date Detail:
Created Date:  2014-10-4     Completed Date:  -     Revised Date:  2014-10-5    
Medline Journal Info:
Nlm Unique ID:  1302751     Medline TA:  Neuroradiology     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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