Flow Diversion in Intracranial Aneurysm Treatment

Summary

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.

Conditions

• Intracranial Aneurysm

Interventions

PROCEDURE

flow diversion

endovascular treatment with flow diversion including standard management of thrombo-embolic risk

OTHER

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

Sponsors & Collaborators

• Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  collaborator OTHER

• Centre hospitalier de l'Université de Montréal (CHUM)

  lead OTHER

Principal Investigators

• Jean Raymond, MD · Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-02

Primary Completion

2023-01-31

Completion

2023-01-31

Countries

• Canada

Study Locations