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

Completed

• Conditions: Intracranial Aneurysm

• Registration Number: NCT03423290
• Lead Sponsor: Microvention-Terumo, Inc.

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 Timeline

• Study Start: 2017-11-23
• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-06
• Primary Completion: 2021-09-30
• Study Completion: 2022-01-26
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality rate	6 months	patients with mRS=6
Complete aneurysm occlusion without ˃ 50% parent artery stenosis	6 months	Evaluated by Corelab
Morbidity rate	6 months	patients with mRS\>2

Trial Locations

Locations (7)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

University Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom

Western General Hospital - NHS Lothian; 🇬🇧 Edinburgh, United Kingdom

Brighton & Sussex Universitys Hospitals; 🇬🇧 Brighton, United Kingdom

University Hospitals of North Midlands NHS Trust; 🇬🇧 Stoke-on-Trent, United Kingdom

The Walton Centre NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle Upon Tyne, United Kingdom