An interventional study of flow diversion and conservative management in Intracranial Aneurysm, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 3 sites in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and 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.
Background:
Intracranial aneurysms, particularly large/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. Early series and registries of the use of FDs in various types of aneurysms have reported treatment-related morbidity and mortality ranging from 0 to 4 and 8% respectively, most often from delayed haemorrhage. Hence, although there is growing enthusiasm to use these powerful new tools, complications are increasingly reported.
Rationale and Hypothesis:
There is an urgent need to offer the new tool afforded by FDs to patients currently presenting with a difficult aneurysm, in a context that can offer protection from over-optimistic perspectives, fashion, learning curves and marketing. Only a randomized clinical trial can offer such protection as well as provide an answer to the question of which treatment option leads to better patient outcomes. The primary hypothesis is that flow diversion can be performed with an "acceptable" immediate complication rate, defined as less than 15% morbidity and mortality (modified Rankin Score > 2 at 3 months), AND increase the number of patients experiencing successful therapy, defined as complete or near complete occlusion of the aneurysm from 75 to 90%.
Objectives:
Compare flow diversion (FD) to Best-Standard Treatment (BST) in the context of an RCT. BST may be any of the following: 1) conservative management; 2) coiling with or without high porosity stenting; 3) parent vessel occlusion with or without bypass; 4) surgical clipping; 5) enter a registry for FD, when the only treatment alternative is FD for compassionate use.
Methods:
Following randomization to FD or BST, patients will undergo the assigned intervention and be followed for 12 months. Clinical status will be recorded at discharge, at 1-3 months, and at 3-12 months. Angiographic evaluation will be recorded at 3-12 months. Adverse Events will be recorded immediately after the procedure and during the 12-month follow-up period. Patients in the FD registry will similarly be followed for 12 months. A total of 344 patients will be recruited in 20 centers worldwide. The trial is expected to last for 5 years.
Analysis:
Comparability between FD and BST groups will use descriptive statistics or frequency tables, independent ANOVAs or Mantel-Haentzel and chi-square tests. Comparison of primary outcome will use a z-test for independent proportions at 12 months. Safety data will be compared through independent t-tests or chi-square statistics. Logistic regression will be used to find variables capable of predicting success in both groups at 12 months.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's enrollment of 323 is above the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Flow diverters are low porosity braided endovascular stent devices. They can be used with or without coiling.
Procedure: flow diversion
Best standard treatment can by any of the standard management options: coiling, stenting plus coiling, surgical clipping, parent vessel occlusion, observation
Other: conservative management · Procedure: endovascular coiling · Procedure: balloon parent vessel occlusion · Procedure: surgical clipping
Flow 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
Procedure: flow diversion
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
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.
Time frame: 12 months
modified Rankin score
modified Rankin score at discharge, and at 3 and 12 months post-treatment (last observation carried forward)
Time frame: discharge, 3 and 12 months
rate of peri-operative complications
rate of ischemic strokes and intracranial hemorrhages during the peri-operative period
Time frame: 30 days
rate of Adverse Events
rate of new stroke, neurological symptom or sign during follow-up
Time frame: 12 months
angiographic outcome
degree of occlusion of aneurysm as assessed by invasive or non-invasive imaging (last observation carried forward
Time frame: 12 months
rate of retreatment of index aneurysm
rate of retreatment of index aneurysm due residual aneurysm after initial treatment
Time frame: 12 months
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Centre hospitalier de l'Université de Montréal (CHUM)