Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment
1 other identifier
observational
61
1 country
7
Brief Summary
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2017
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2017
CompletedFirst Submitted
Initial submission to the registry
January 31, 2018
CompletedFirst Posted
Study publicly available on registry
February 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedApril 29, 2022
April 1, 2022
3.9 years
January 31, 2018
April 28, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
Interventions
Flow Re-Direction Endoluminal Device
Eligibility Criteria
Patients aged a minimum of 18 years with an unruptured or recanalized intracranial aneurysm in whom endovascular treatment has been determined the appropriate treatment
You may qualify if:
- Patient older than 18 years old
- 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
- Patient with a modified Rankin Scale (mRS) ≤ 2
- Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
You may not qualify if:
- Patient has suffered an ICH within the 30 days prior to the procedure.
- The aneurysm to be treated is associated with an cAVM
- The aneurysm to be treated is a dissecting or blister-like aneurysm
- The aneurysm to be treated or any other aneurysm is in the posterior circulation
- The aneurysm to be treated has a stenosis of its parent artery
- 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
- Patient has another aneurysm requiring treatment within the study period
- Patient with a known allergy to antiplatelet, to heparin, to contrast products or nickel titanium
- Patient with a contra-indication to antiplatelet or heparin
- Pregnancy or child breastfeeding
- Patient unable or unlikely to complete required follow up
- Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
- Treatment with a flow diverter other than FRED/FRED Jr or in addition to FRED/FRED Jr is planned.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Microvention-Terumo, Inc.lead
- Clinactcollaborator
Study Sites (7)
University Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
Brighton & Sussex Universitys Hospitals
Brighton, BN2 5BE, United Kingdom
Western General Hospital - NHS Lothian
Edinburgh, EH4 2XU, United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, L97 LJ, United Kingdom
Imperial College Healthcare NHS Trust
London, W6 8RF, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyriakos Lobotesis, MD
Imperial College Healthcare NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2018
First Posted
February 6, 2018
Study Start
November 23, 2017
Primary Completion
September 30, 2021
Study Completion
January 26, 2022
Last Updated
April 29, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share