Intracranial AneurysmFIATNCT01349582
Flow Diversion in Intracranial Aneurysm Treatment
A study testing flow diversion, conservative management and endovascular coiling in people with Intracranial Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- flow diversion, conservative management and endovascular coiling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 3 sitesCanada
- Study dates
- 2 May 2011to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Alberta Hospital
Edmonton, Alberta
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Montreal, Quebec, H2X 0C1
The Ottawa Hospital
Ottawa, Ontario
About this study
Official title: A Randomized Trial Comparing Flow Diversion and Best-standard Treatment - the FIAT Trial
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.
Read the detailed 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.
- Conditions
- Intracranial Aneurysm
- Being tested
- flow diversion, conservative management, endovascular coiling, balloon parent vessel occlusion, surgical clipping
- Keywords
- flow diversion, endovascular treatment, symptomatic aneurysm, cavernous carotid aneurysm, ophthalmic aneurysm, vertebral aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow diversionProcedure or surgery
endovascular treatment with flow diversion including standard management of thrombo-embolic risk
conservative managementOther
conservative management is watchful observation of the aneurysm until indication for intervention arises
endovascular coilingProcedure or surgery
standard endovascular coiling of aneurysm with any type of already approved coil. High porosity stents may be used as an adjunct technique to coiling
balloon parent vessel occlusionProcedure or surgery
sacrifice of parent artery of aneurysm by endovascular balloon occlusion with or without bypass
surgical clippingProcedure or surgery
clipping of the aneurysm following invasive brain surgery
| Study group | Role | What they receive |
|---|---|---|
| flow diversion | Active comparator | Flow diverters are low porosity braided endovascular stent devices. They can be used with or without coiling. Receives: Procedure: flow diversion |
| Best standard treatment | Active comparator | Best standard treatment can by any of the standard management options: coiling, stenting plus coiling, surgical clipping, parent vessel occlusion, observation Receives: Other: conservative management; Procedure: endovascular coiling; Procedure: balloon parent vessel occlusion; Procedure: surgical clipping |
| Registry for flow diversion | Other | 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 Receives: Procedure: flow diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
modified Rankin score
modified Rankin score at discharge, and at 3 and 12 months post-treatment (last observation carried forward)
Measured: discharge, 3 and 12 months
rate of peri-operative complications
rate of ischemic strokes and intracranial hemorrhages during the peri-operative period
Measured: 30 days
rate of Adverse Events
rate of new stroke, neurological symptom or sign during follow-up
Measured: 12 months
angiographic outcome
degree of occlusion of aneurysm as assessed by invasive or non-invasive imaging (last observation carried forward
Measured: 12 months
rate of retreatment of index aneurysm
rate of retreatment of index aneurysm due residual aneurysm after initial treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study start2 May 2011
- Primary completionJan 2023
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Jean Raymond, MD, Principal investigator, Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349582
- Sponsor's protocol ID
- CE10.206
- Acronym
- FIAT
- Status last verified
- Jul 2023
- First submitted
- 4 May 2011
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27813466
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Flow Diversion and Best-standard Treatment - the FIAT Trial
- ClinicalTrials.gov ID
- NCT01349582
- Acronym / sponsor ID
- FIAT / CE10.206
- Conditions
- Intracranial Aneurysm
- Keywords
- flow diversion, endovascular treatment, symptomatic aneurysm, cavernous carotid aneurysm, ophthalmic aneurysm, vertebral aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- 2 May 2011 (actual)
- Primary completion
- Jan 2023 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| flow diversion | Active comparator | Procedure: flow diversionFlow diverters are low porosity braided endovascular stent devices. They can be used with or without coiling. |
| Best standard treatment | Active comparator | Other: conservative management, Procedure: endovascular coiling, Procedure: balloon parent vessel occlusion, Procedure: surgical clippingBest standard treatment can by any of the standard management options: coiling, stenting plus coiling, surgical clipping, parent vessel occlusion, observation |
| Registry for flow diversion | Other | Procedure: flow diversionFlow 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flow diversionendovascular treatment with flow diversion including standard management of thrombo-embolic risk | Procedure or surgery | Registry for flow diversion, flow diversion |
| conservative managementconservative management is watchful observation of the aneurysm until indication for intervention arises | Other | Best standard treatment |
| endovascular coilingstandard endovascular coiling of aneurysm with any type of already approved coil. High porosity stents may be used as an adjunct technique to coiling | Procedure or surgery | Best standard treatment |
| balloon parent vessel occlusionsacrifice of parent artery of aneurysm by endovascular balloon occlusion with or without bypass | Procedure or surgery | Best standard treatment |
| surgical clippingclipping of the aneurysm following invasive brain surgery | Procedure or surgery | Best standard treatment |
Primary outcome
rate of success of therapy
Time frame: 12 months
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.
5 secondary outcomes
modified Rankin score
Time frame: discharge, 3 and 12 months
rate of peri-operative complications
Time frame: 30 days
rate of Adverse Events
Time frame: 12 months
angiographic outcome
Time frame: 12 months
rate of retreatment of index aneurysm
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 27813466Raymond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Raymond, MD principal investigator
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flow diversion, conservative management and endovascular coiling in people with Intracranial Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of success of therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01349582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.