title: 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.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Interventional Neuroradiology, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, 59 Bd Pinel, 69677, Bron, France, francis.turjman@chu-lyon.fr.
authors.forename: Francis
authors.initials: F
authors.lastname: Turjman
authors.forename: Olivier
authors.initials: O
authors.lastname: Levrier
authors.forename: Xavier
authors.initials: X
authors.lastname: Combaz
authors.forename: Alain
authors.initials: A
authors.lastname: Bonafé
authors.forename: Alessandra
authors.initials: A
authors.lastname: Biondi
authors.forename: Hubert
authors.initials: H
authors.lastname: Desal
authors.forename: Serge
authors.initials: S
authors.lastname: Bracard
authors.forename: Charbel
authors.initials: C
authors.lastname: Mounayer
authors.forename: Roberto
authors.initials: R
authors.lastname: Riva
authors.forename: Francois
authors.initials: F
authors.lastname: Chapuis
authors.forename: Laure
authors.initials: L
authors.lastname: Huot
authors.forename: Xavier
authors.initials: X
authors.lastname: Armoiry
authors.forename: Benjamin
authors.initials: B
authors.lastname: Gory
mesh_terms: D000328:Adult; D000368:Aged; D057510:Endovascular Procedures / Q000295:instrumentation*; D005260:Female; D005602:France; D006801:Humans; D002532:Intracranial Aneurysm / Q000175:diagnosis* / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D059906:Neuroimaging; D011446:Prospective Studies; D012107:Research Design