Trials / Active Not Recruiting
Active Not RecruitingNCT03920358
FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 156 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FRED, FRED Jr and FRED X | Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm |
Timeline
- Start date
- 2019-04-10
- Primary completion
- 2023-06-09
- Completion
- 2027-12-30
- First posted
- 2019-04-18
- Last updated
- 2025-01-08
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03920358. Inclusion in this directory is not an endorsement.