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

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

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: FRED and FRED Jr

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 Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospital Birmingham
  • Brighton, United Kingdom, BN2 5BE
    • Brighton & Sussex Universitys Hospitals
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital - NHS Lothian
  • Liverpool, United Kingdom, L97 LJ
    • The Walton Centre NHS Foundation Trust
  • London, United Kingdom, W6 8RF
    • Imperial College Healthcare NHS Trust
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • University Hospitals of North Midlands NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged a minimum of 18 years with an unruptured or recanalized intracranial aneurysm in whom endovascular treatment has been determined the appropriate treatment

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete aneurysm occlusion without ˃ 50% parent artery stenosis	Evaluated by Corelab	6 months
Morbidity rate	patients with mRS>2	6 months
Mortality rate	patients with mRS=6	6 months

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Collaborators: Clinact
• Investigators: Principal Investigator: Kyriakos Lobotesis, MD, Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 23, 2017
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): January 26, 2022

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (ACTUAL): February 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: FRED-UK Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No