Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms

Study Overview
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Brief Summary
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The study objective is to evaluate the safety and effectiveness of the MicroVention FRED System when used in the treatment of wide-necked intracranial aneurysms.

Official Title
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Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms - The CanFRED Trial

Conditions
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Intracranial Aneurysms

Intervention / Treatment
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* Device: FRED


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject whose age is ≥ 18 years; Subject has a single target aneurysm located in the following zones: Zone 1 - Petrous through cavernous of the ICA Zone 2 - Ophthalmic segment of the ICA Zone 3-Posterior Circulation, basilar artery (not including the basilar bifurcation), vertebral artery Subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics: Aneurysms with a neck > 4mm, dome to neck ratio ≤2 or no discernible neck Fusiform aneurysms of any size requiring treatment; The parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (IA); Subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form; Negative pregnancy test in a female subject who has had menses in the last 24 months; Subject is willing to return for the 1-month and 6-month follow-up evaluations Exclusion Criteria: Subject who is pregnant or breastfeeding; Subject who suffers from a subarachnoid hemorrhage in the last 60 days; Subject who suffers from any intracranial hemorrhage in the last 30 days; Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region; Subject with stenosis of the parent artery (>50%) proximal to the target aneurysm; Subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents; Subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor); Subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry Subject with documented contrast allergy, or other condition, that prohibits imaging. Evidence of active bacterial infection at the time of treatment; Subject who has had a previous intracranial stenting procedure associated with the target aneurysm; Subject with life-threatening diseases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flow Re-Direction Endoluminal Device<br>Flow Re-Direction Endoluminal Device (FRED Device) | Device: FRED<br>* Flow Re-Direction Endoluminal Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death or major stroke | A major stroke is defined as a new neurological event that persists for > 24 hours and results in a mRS >2. A minor stroke is defined as a new neurological event that persists for > 24 hours. | within 30 days post procedure | 
| neurological death or major ipsilateral stroke, measured by mRS. |  | within 6 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of FRED System and procedure related Serious Adverse Events; |  | 1 year | 
| Incidence of successful delivery of the FRED System implant; |  | 24 hours | 
| Incidence of migration of the FRED System implant |  | 6 months | 
| Unplanned alternative treatment on the target IA (Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject) | Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject | Within 6 months | 
| Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline) | as measured by an increase in the modified Rankin Scale compared to baseline | 6 months |