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

Intracranial Aneurysm Clinical Trial

Official title:

Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment, a UK, Multi-center, Single Arm, Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423290
• Other study ID #: FRED-UK Registry
• Status: Completed
• Start date: November 23, 2017
• Est. completion date: January 26, 2022

Study information

• Verified date: April 2022
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 26, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• FRED and FRED Jr
Flow Re-Direction Endoluminal Device

Locations

Country	Name	City	State
United Kingdom	University Hospital Birmingham	Birmingham
United Kingdom	Brighton & Sussex Universitys Hospitals	Brighton
United Kingdom	Western General Hospital - NHS Lothian	Edinburgh
United Kingdom	The Walton Centre NHS Foundation Trust	Liverpool
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent

Sponsors (2)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.	Clinact

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete aneurysm occlusion without ? 50% parent artery stenosis	Evaluated by Corelab	6 months
Primary	Morbidity rate	patients with mRS>2	6 months
Primary	Mortality rate	patients with mRS=6	6 months