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 performed as per standard of care. The purpose of this study is to demonstrate that use of the FRED/ FRED Jr/ FRED X Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure. 150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years.
Interventions
DEVICEFRED, FRED Jr and FRED X
Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm
Sponsors
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 a non-acutely ruptured intracranial aneurysm within the last 30 days of presentation: * for which use of FRED, FRED Jr or FRED X has been deemed appropriate * being the only aneurysm to require treatment within the next 12 months * 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 has received information about data collection and has signed and dated an Informed Consent Form
Exclusion criteria
1. Patient has suffered from an ICH within the 30 days prior to the procedure. 2. The aneurysm to be treated is associated with a cAVM 3. The aneurysm to be treated is in the posterior circulation 4. The aneurysm to be treated has a stenosis of its parent artery \>50% 5. Patient has another aneurysm previously treated with a stent or a flow diverter * on the same parent vessel at any time * on a different parent vessel, less than 3 months prior to the procedure (previously-implanted stents in the non-index proximal carotid are acceptable) 6. Patient with whom anticoagulant, antiplatelet or thrombolytic drugs are contra-indicated or test performed regarding AP medication administered is not efficient for the patient 7. Patient with known hypersensitivity to contrast products or nickel titanium, not treatable 8. Pregnancy or child breastfeeding 9. Patient unable or unlikely to complete required follow up 10. Patient has severe or fatal comorbidity or a life expectancy of less than 1 year 11. Treatment with a flow diverter other than FRED/ FRED Jr/ FRED X or in addition to FRED/ FRED Jr/ FRED X is planned
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%) | 12 months | Complete occlusion (Raymond Scale grade I) without stenosis of the parent artery. Raymond scale definition: Grade I= complete occlusion of aneurysm, Grade II= Residual neck, Grade III= Residual aneurysm |
| Morbidity Rate | 6 months | Patients with mRS\>2 |
| Mortality Rate | 6 months | Deaths within 6 months after treatment |
Countries
Germany
Outcome results
None listed