Flow Diversion in Intracranial Aneurysm Treatment (FIAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01349582
First received: May 4, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Intracranial Aneurysm
Procedure: flow diversion
Other: conservative management
Procedure: endovascular coiling
Procedure: balloon parent vessel occlusion
Procedure: surgical clipping
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Flow Diversion and Best-standard Treatment - the FIAT Trial

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • rate of success of therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • modified Rankin score [ Time Frame: discharge, 3 and 12 months ] [ Designated as safety issue: Yes ]
    modified Rankin score at discharge, and at 3 and 12 months post-treatment (last observation carried forward)

  • rate of peri-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    rate of ischemic strokes and intracranial hemorrhages during the peri-operative period

  • rate of Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    rate of new stroke, neurological symptom or sign during follow-up

  • angiographic outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    degree of occlusion of aneurysm as assessed by invasive or non-invasive imaging (last observation carried forward

  • rate of retreatment of index aneurysm [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 344
Study Start Date: April 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: flow diversion Procedure: flow diversion
endovascular treatment with flow diversion including standard management of thrombo-embolic risk
Active Comparator: Best standard treatment Other: conservative management
conservative management is watchful observation of the aneurysm until indication for intervention arises
Procedure: 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
Procedure: balloon parent vessel occlusion
sacrifice of parent artery of aneurysm by endovascular balloon occlusion with or without bypass
Procedure: surgical clipping
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
Procedure: flow diversion
endovascular treatment with flow diversion including standard management of thrombo-embolic risk

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349582

Contacts
Contact: Jean Raymond, MD 514-890-8000 ext 27235 jraymond.nri@gmail.com

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Tim - Darsaut, MD, MSc       Tim.Darsaut@albertahealthservices.ca   
Principal Investigator: Tim - Darsaut, MD, MSc         
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada
Contact: Betty Anne Schwarz       baschwarz@Ottawahospital.on.ca   
Principal Investigator: Marlise Santos, MD         
Canada, Quebec
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Suzanne Nolet, BSc    514-890-8000 ext 26359    suzanne.nolet@crchum.qc.ca   
Principal Investigator: Jean Raymond, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Jean Raymond, MD Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01349582     History of Changes
Other Study ID Numbers: CE10.206
Study First Received: May 4, 2011
Last Updated: May 28, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
flow diversion
endovascular treatment
symptomatic aneurysm
cavernous carotid aneurysm
ophthalmic aneurysm
vertebral aneurysm

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014