Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01349582 |
| Other study ID # |
CE10.206 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2011 |
| Est. completion date |
January 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Centre hospitalier de l'Université de Montréal (CHUM) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
