Intracranial Aneurysms
Conditions
Brief summary
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.
Interventions
DEVICEFRED
Flow Re-Direction Endoluminal Device
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| death or major stroke | within 30 days post procedure | 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. |
| neurological death or major ipsilateral stroke, measured by mRS. | within 6 months post procedure | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of migration of the FRED System implant | 6 months | — |
| Incidence of FRED System and procedure related Serious Adverse Events; | 1 year | — |
| Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline) | 6 months | as measured by an increase in the modified Rankin Scale compared to baseline |
| 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) | Within 6 months | Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject |
| Incidence of successful delivery of the FRED System implant; | 24 hours | — |
Outcome results
None listed