Journal of neurosurgery
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Journal of neurosurgery · Sep 2017
Randomized Controlled Trial Multicenter StudyFlow diversion in the treatment of aneurysms: a randomized care trial and registry.
OBJECTIVE The Flow Diversion in the Treatment of Intracranial Aneurysm Trial (FIAT) was designed to guide the clinical use of flow diversion, an innovative method to treat intracranial aneurysms, within a care trial and to study safety and efficacy. METHODS FIAT, conducted in 3 Canadian hospitals, proposed randomized allocation to flow diversion or standard management options (observation, coil embolization, parent vessel occlusion, or clip placement), and a registry of non-randomized patients treated with flow diversion. The primary safety outcome was death or dependency (modified Rankin Scale score > 2) at 3 months, to be determined for all patients who received flow diversion at any time. ⋯ CONCLUSIONS Flow diversion was not as safe and effective as hypothesized. More randomized trials are needed to determine the role of flow diversion in the management of aneurysms. Clinical trial registration no.: NCT01349582 (clinicaltrials.gov).