title: Flow diversion in aneurysms trial: the design of the FIAT study.
abstract: Intracranial aneurysms, particularly large and giant, fusiform or recurrent aneurysms are increasingly treated with flow diverters (FDs), a recently introduced and approved neurovascular device. While some rare cases may not be treated any other way, in most patients a more conventional, conservative, or validated approach such as coiling, parent vessel occlusion, or surgical clipping exists. Only a randomized clinical trial can answer the question of which treatment option leads to better patient outcomes.We report the design of the FIAT study, a clinical care trial aiming to compare angiographic and clinical outcomes following treatment with a Flow-Diverter or with the best conventional treatment option. The FIAT study will include both a randomized and a registry portion. Patients will be proposed randomization to either FD stenting or best conventional treatment option (observation, coiling, stenting, or clipping) as determined by the treating physician. FIAT will recruit a total of 338 patients, to show that i) FD stenting can be performed with an 'acceptable' immediate complication rate of less than 15% morbidity and mortality (defined as mRS > 2); ii) FD stenting can increase from 75 to 90% the proportion of patients with a "good outcome", defined as complete or near-complete occlusion of the aneurysm AND a good clinical outcome (mRS ≥ 2) at one year, as compared to the best conventional option. The FIAT study provides a scientific and ethical context to care for patients eligible for flow-diversion therapy.
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology and Interventional Neuroradiology Research Unit, Montreal, Quebec, Canada. jean.raymond@umontreal.ca
authors.forename: J
authors.initials: J
authors.lastname: Raymond
authors.forename: T E
authors.initials: TE
authors.lastname: Darsaut
authors.forename: F
authors.initials: F
authors.lastname: Guilbert
authors.forename: A
authors.initials: A
authors.lastname: Weill
authors.forename: D
authors.initials: D
authors.lastname: Roy
mesh_terms: D006801:Humans; D002532:Intracranial Aneurysm / Q000601:surgery*; D019635:Neurosurgical Procedures / Q000295:instrumentation* / Q000379:methods*; D019736:Prostheses and Implants; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012042:Registries