Intracranial Aneurysm
Conditions
Brief summary
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms
Detailed description
This is a multi-center observational study. Treatment and follow-up visits will be done as per standard of care. The purpose of this study is to demonstrate that use of the FRED/FRED Jr Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 1, 6 and 12 month post procedure. 100 patients will be enrolled over an 18-month recruitment period. All patients will be followed for 12 months.
Interventions
DEVICEFRED and FRED Jr
Flow Re-Direction Endoluminal Device
Sponsors
Clinact
Microvention-Terumo, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient older than 18 years old 2. Patient harboring an unruptured intracranial aneurysm: * for which endovascular treatment is indicated * for which use of FRED or FRED Jr has been deemed appropriate * being the only one to require treatment over the period of the study * and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized 3. Patient with a modified Rankin Scale (mRS) ≤ 2 4. Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
Exclusion criteria
1. Patient has suffered an ICH within the 30 days prior to the procedure. 2. The aneurysm to be treated is associated with an cAVM 3. The aneurysm to be treated is a dissecting or blister-like aneurysm 4. The aneurysm to be treated or any other aneurysm is in the posterior circulation 5. The aneurysm to be treated has a stenosis of its parent artery 6. Patient has another aneurysm previously treated with a stent or a flow diverter * on the same parent vessel at any time (except in the case of the proximal carotid if the treatment occurred more than 3 months prior to the procedure) * on a different parent vessel, less than 3 months prior to the procedure 7. Patient has another aneurysm requiring treatment within the study period 8. Patient with a known allergy to antiplatelet, to heparin, to contrast products or nickel titanium 9. Patient with a contra-indication to antiplatelet or heparin 10. Pregnancy or child breastfeeding 11. Patient unable or unlikely to complete required follow up 12. Patient has severe or fatal comorbidity or a life expectancy of less than 1 year 13. Treatment with a flow diverter other than FRED/FRED Jr or in addition to FRED/FRED Jr is planned.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete aneurysm occlusion without ˃ 50% parent artery stenosis | 6 months | Evaluated by Corelab |
| Morbidity rate | 6 months | patients with mRS\>2 |
| Mortality rate | 6 months | patients with mRS=6 |
Countries
United Kingdom
Outcome results
None listed