Flow Diversion in Intracranial Aneurysm Treatment
FIAT
A Randomized Trial Comparing Flow Diversion and Best-standard Treatment - the FIAT Trial
1 other identifier
interventional
323
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2011
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2011
CompletedFirst Submitted
Initial submission to the registry
May 4, 2011
CompletedFirst Posted
Study publicly available on registry
May 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedJuly 6, 2023
July 1, 2023
11.7 years
May 4, 2011
July 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of success of therapy
Rate of success increases from 75% to 90%, with success defined as complete or near complete occlusion of the aneurysm combined with a modified Rankin score of less or equal to 2.
12 months
Secondary Outcomes (5)
modified Rankin score
discharge, 3 and 12 months
rate of peri-operative complications
30 days
rate of Adverse Events
12 months
angiographic outcome
12 months
rate of retreatment of index aneurysm
12 months
Study Arms (3)
flow diversion
ACTIVE COMPARATORFlow diverters are low porosity braided endovascular stent devices. They can be used with or without coiling.
Best standard treatment
ACTIVE COMPARATORBest standard treatment can by any of the standard management options: coiling, stenting plus coiling, surgical clipping, parent vessel occlusion, observation
Registry for flow diversion
OTHERFlow diversion when randomization between flow diversion and best standard treatment is not possible and the only alternative is flow diversion for compassionate use. In this case there will be no random allocation but the patient will be entered into a registry
Interventions
endovascular treatment with flow diversion including standard management of thrombo-embolic risk
conservative management is watchful observation of the aneurysm until indication for intervention arises
standard endovascular coiling of aneurysm with any type of already approved coil. High porosity stents may be used as an adjunct technique to coiling
sacrifice of parent artery of aneurysm by endovascular balloon occlusion with or without bypass
clipping of the aneurysm following invasive brain surgery
Eligibility Criteria
You may qualify if:
- Any patient with a "difficult" intracranial aneurysm in whom flow diversion is considered an appropriate if not the best but yet unproved therapeutic option by the participating clinician. Current indications may be (but not restricted to) symptomatic large or giant cavernous carotid, ophthalmic and vertebral aneurysms, fusiform intradural aneurysms, or recurring, persistent lesions after previous coiling. Aneurysm may be a recent rupture, although risks associated with antiplatelet regimens in this context should make this option rarely used
You may not qualify if:
- Severe allergy, intolerance or bleeding disorder that prohibit the use of ASA or clopidogrel.
- Absolute contraindication to endovascular treatment or anesthesia.
- Patients unable to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Alberta Hospital
Edmonton, Alberta, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Montreal, Quebec, H2X 0C1, Canada
Related Publications (1)
Raymond J, Gentric JC, Darsaut TE, Iancu D, Chagnon M, Weill A, Roy D. Flow diversion in the treatment of aneurysms: a randomized care trial and registry. J Neurosurg. 2017 Sep;127(3):454-462. doi: 10.3171/2016.4.JNS152662. Epub 2016 Nov 4.
PMID: 27813466DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Raymond, MD
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2011
First Posted
May 6, 2011
Study Start
May 2, 2011
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
July 6, 2023
Record last verified: 2023-07