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Procedure
Registry for flow diversion for Brain Aneurysm (FIAT Trial)
N/A
Waitlist Available
Led By Jean Raymond, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up discharge, 3 and 12 months
Awards & highlights
Summary
This trial is testing whether a flow diverter, a new device used to treat intracranial aneurysms, is effective and has an acceptable rate of complications.
Eligible Conditions
- Brain Aneurysm
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ discharge, 3 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~discharge, 3 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
rate of success of therapy
Secondary outcome measures
angiographic outcome
modified Rankin score
rate of Adverse Events
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Registry for flow diversionExperimental Treatment1 Intervention
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 II: flow diversionActive Control1 Intervention
Flow diverters are low porosity braided endovascular stent devices. They can be used with or without coiling.
Group III: Best standard treatmentActive Control4 Interventions
Best standard treatment can by any of the standard management options: coiling, stenting plus coiling, surgical clipping, parent vessel occlusion, observation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
flow diversion
2011
N/A
~330
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
370 Previous Clinical Trials
129,492 Total Patients Enrolled
Centre de Recherche du Centre Hospitalier de l'Université de MontréalOTHER
52 Previous Clinical Trials
94,004 Total Patients Enrolled
Jean Raymond, MDPrincipal InvestigatorCentre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
9 Previous Clinical Trials
3,992 Total Patients Enrolled
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