Flow Diversion in Intracranial Aneurysm Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-02

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

International Subarachnoid Aneurysm Trial II

NCT01668563

Intracranial Hemorrhage Ruptured Aneurysm

ACTIVE_NOT_RECRUITING NA

Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques

NCT01084681

Intracranial Aneurysms

UNKNOWN NA

Middle Cerebral Artery Aneurysm Trial

NCT05161377

Middle Cerebral Artery Aneurysm

RECRUITING NA

Trial on Endovascular Aneurysm Management

NCT00537134

Brain Aneurysm

TERMINATED NA

International Retrospective Study of Pipeline Embolization Device

NCT01558102

Brain Aneurysms

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

flow diversion

Flow diverters are low porosity braided endovascular stent devices. They can be used with or without coiling.

Group Type ACTIVE_COMPARATOR

flow diversion

Intervention Type PROCEDURE

endovascular treatment with flow diversion including standard management of thrombo-embolic risk

Best standard treatment

Best standard treatment can by any of the standard management options: coiling, stenting plus coiling, surgical clipping, parent vessel occlusion, observation

Group Type ACTIVE_COMPARATOR

conservative management

Intervention Type OTHER

conservative management is watchful observation of the aneurysm until indication for intervention arises

endovascular coiling

Intervention Type PROCEDURE

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 occlusion

Intervention Type PROCEDURE

sacrifice of parent artery of aneurysm by endovascular balloon occlusion with or without bypass

surgical clipping

Intervention Type PROCEDURE

clipping of the aneurysm following invasive brain surgery

Registry for flow diversion

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

Group Type OTHER

flow diversion

Intervention Type PROCEDURE

endovascular treatment with flow diversion including standard management of thrombo-embolic risk

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

flow diversion

endovascular treatment with flow diversion including standard management of thrombo-embolic risk

Intervention Type PROCEDURE

conservative management

conservative management is watchful observation of the aneurysm until indication for intervention arises

Intervention Type OTHER

endovascular coiling

standard endovascular coiling of aneurysm with any type of already approved coil. High porosity stents may be used as an adjunct technique to coiling

Intervention Type PROCEDURE

balloon parent vessel occlusion

sacrifice of parent artery of aneurysm by endovascular balloon occlusion with or without bypass

Intervention Type PROCEDURE

surgical clipping

clipping of the aneurysm following invasive brain surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No