NCT03423290CompletedNot Applicable
Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment, a UK, Multi-center, Single Arm, Prospective Observational Study
Microvention-Terumo, Inc.7 sites in 1 country61 target enrollmentStarted: November 23, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 61
- Locations
- 7
- Primary Endpoint
- Morbidity rate
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient older than 18 years old
- •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
- •Patient with a modified Rankin Scale (mRS) ≤ 2
- •Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
Exclusion Criteria
- •Patient has suffered an ICH within the 30 days prior to the procedure.
- •The aneurysm to be treated is associated with an cAVM
- •The aneurysm to be treated is a dissecting or blister-like aneurysm
- •The aneurysm to be treated or any other aneurysm is in the posterior circulation
- •The aneurysm to be treated has a stenosis of its parent artery
- •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
- •Patient has another aneurysm requiring treatment within the study period
- •Patient with a known allergy to antiplatelet, to heparin, to contrast products or nickel titanium
- •Patient with a contra-indication to antiplatelet or heparin
- •Pregnancy or child breastfeeding
- •Patient unable or unlikely to complete required follow up
- •Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
- •Treatment with a flow diverter other than FRED/FRED Jr or in addition to FRED/FRED Jr is planned.
Outcomes
Primary Outcomes
Morbidity rate
Time Frame: 6 months
patients with mRS\>2
Mortality rate
Time Frame: 6 months
patients with mRS=6
Complete aneurysm occlusion without ˃ 50% parent artery stenosis
Time Frame: 6 months
Evaluated by Corelab
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (7)
Loading locations...
Similar Trials
Completed
Not Applicable
Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm TreatmentIntracranial AneurysmsNCT02921698Microvention-Terumo, Inc.100
Completed
Not Applicable
FRED and FRED JR Devices for Intracranial Aneurysm TreatmentIntracranial AneurysmNCT04315168Microvention-Terumo, Inc.135
Active, not recruiting
Not Applicable
FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment StudyIntracranial AneurysmNCT03920358Microvention-Terumo, Inc.156
Unknown
Not Applicable
Safety and Efficacy of Radio Frequency for the Treatment of Mild to Severe Inflammatory AcneInflammatory Acne VulgarisNCT05830968InMode MD Ltd.42
Completed
Not Applicable
RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue InjurySoft Tissue InjuriesNCT03774823Venus Concept10