Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01349582
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2011-05-04
Brief Title:
Flow Diversion in Intracranial Aneurysm Treatment
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
A Randomized Trial Comparing Flow Diversion and Best-standard Treatment - the FIAT Trial
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIAT
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
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
Detailed Description:
Background
Intracranial aneurysms particularly largegiant 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
Intracranial aneurysms particularly largegiant 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None