Flow Diversion in Intracranial Aneurysm Treatment
common.study.values.description
“Flow Diversion in Intracranial Aneurysm Treatment”
Flow diverters are a recent addition to the range of endovascular devices now available for the treatment of intracranial aneurysms. The FIAT trial aims at comparing flow diversion to best standard treatment in the context of a randomised controlled trial. Best standard treatment may include any of the following and will be left to the treating physician to decide : 1) conservative management; 2) coiling with or without high porosity stenting; 3) parent vessel occlusion with or without bypass; 4) surgical clipping. If the only treatment alternative is deemed to be flow diversion for compassionate use, then randomisation will not be carried out, but patient will enter a registry and her data recorded according to same schedule as randomised patients. The primary hypothesis is that flow diversion can be performed with an "acceptable" immediate complication rate, defined as less than 15% morbidity and mortality, AND increase the number of patients experiencing successful therapy, defined as complete or near complete occlusion of the aneurysm from 75 to 90%, relative to best standard treatment.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
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                                 common.study.methods.is-healthy-yes
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                                Procedure - flow diversion
endovascular treatment with flow diversion including standard management of thrombo-embolic risk
conservative management
conservative management is watchful observation of the aneurysm until indication for intervention arises
Procedure - endovascular coiling
standard endovascular coiling of aneurysm with any type of already approved coil. High porosity stents may be used as an adjunct technique to coiling
Procedure - balloon parent vessel occlusion
sacrifice of parent artery of aneurysm by endovascular balloon occlusion with or without bypass
Procedure - surgical clipping
clipping of the aneurysm following invasive brain surgery
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participant.views.study.view.scientific-title
A Randomized Trial Comparing Flow Diversion and Best-standard Treatment - the FIAT Trial
common.study.values.clinical-trial-id
NCT01349582
participant.views.study.view.id
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