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

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 (TM) Embolization Device has shown high rates of complete occlusion in uncontrolled clinical series. The study is a prospective, controlled, randomized, multicenter, phase 2 open-label trial. Intention-to-treat population includes age a parts per thousand yen18, unruptured saccular aneurysm located in the intra-dural area, neck diameter a parts per thousand yen4 and a parts per thousand currency sign10 mm, sac diameter a parts per thousand yen7 mm and a parts per thousand currency sign20 mm, ``dome/neck'' ratio is a parts per thousand yen1, diameter of the parent artery a parts per thousand yen2 mm and a parts per thousand currency sign5 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. The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up. 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.