CClinicalTrials.gg
CompletedNCT03423290Updated Apr 29, 2022

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

An observational study in Intracranial Aneurysm, sponsored by Microvention-Terumo, Inc.. Completed at 7 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-29.

Sponsored by Microvention-Terumo, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
61
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Intracranial Aneurysm
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
61 participants (actual)
Patient registry
No

Interventions

  • DeviceFRED and FRED Jr

    Flow Re-Direction Endoluminal Device

05

What researchers measure

Primary outcomes

  1. Complete aneurysm occlusion without ˃ 50% parent artery stenosis

    Evaluated by Corelab

    Time frame: 6 months

  2. Morbidity rate

    patients with mRS\>2

    Time frame: 6 months

  3. Mortality rate

    patients with mRS=6

    Time frame: 6 months

06

Study locations

7 sites
  • 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
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03423290
Lead sponsor
Microvention-Terumo, Inc.
Collaborators
Clinact
Responsible party
Sponsor
First posted
Feb 6, 2018
Start date
Nov 23, 2017
Primary completion
Sep 30, 2021
Completion
Jan 26, 2022
Last update
Apr 29, 2022

Study contacts

Kyriakos Lobotesis, MD
principal investigator · Imperial College Healthcare NHS Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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