Trials / Completed
CompletedNCT03423290
Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment
Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment, a UK, Multi-center, Single Arm, Prospective Observational Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 61 (actual)
- Sponsor
- Microvention-Terumo, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FRED and FRED Jr | Flow Re-Direction Endoluminal Device |
Timeline
- Start date
- 2017-11-23
- Primary completion
- 2021-09-30
- Completion
- 2022-01-26
- First posted
- 2018-02-06
- Last updated
- 2022-04-29
Locations
7 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03423290. Inclusion in this directory is not an endorsement.