Clinical Trial

Flow Diversion in Intracranial Aneurysm Treatment

Study 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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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

Additional Information

Official Study Title

A Randomized Trial Comparing Flow Diversion and Best-standard Treatment - the FIAT Trial

Clinical Trial ID

NCT01349582

ParticipAid ID

QdJqob