Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-23

Study Completion Date

2022-01-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment

NCT02921698

Intracranial Aneurysms

COMPLETED

FRED and FRED JR Devices for Intracranial Aneurysm Treatment

NCT04315168

Intracranial Aneurysm

COMPLETED

FRED Retrospective Study of Intracranial Aneurysms Treatment

NCT06982781

Intracranial Aneurysm

NOT_YET_RECRUITING

Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

NCT01801007

Intracranial Aneurysms

COMPLETED NA

Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms

NCT02309203

Intracranial Aneurysms

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FRED and FRED Jr

Flow Re-Direction Endoluminal Device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No