CClinicalTrials.gg
CompletedNCT04315168Updated Jan 23, 2024

FRED and FRED JR Devices for Intracranial Aneurysm Treatment

An observational study in Intracranial Aneurysm, sponsored by Microvention-Terumo, Inc.. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Microvention-Terumo, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
135
Sex
All
01

Study summary

A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms

Read the detailed description

Post Market Clinical Follow-up. Multicenter observational study. Treatment and follow-up far at least 12 months as per standard of care.

Sample Size: 138 patients.

02

Conditions studied

  • Intracranial Aneurysm

Keywords

  • aneurysm
  • endovascular
  • flow-diverter
03

In context

Intracranial Aneurysm

427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.

This study's enrollment of 135 is below the median of 200 across 198 observational studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

Microvention-Terumo, Inc. is the lead sponsor of 32 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with an intracranial aneurysm treated with the FRED or FRED JR Device

Inclusion criteria

  • Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device FRED or FRED JR
  • Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
135 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • DeviceFRED and FRED JR

    Intracranial aneurysm treatment

    Also known as: Flow Re-Direction Endoluminal Device

06

What researchers measure

Primary outcomes

  1. Mortality Rate

    Percentage of patients with neurological death

    Time frame: 1 year

  2. Morbidity Rate

    Percentage of patients with major ipsilateral stroke

    Time frame: 1 year

Secondary outcomes

  1. modified Rankin Score

    worsening mRS (scale from 0 to 6 : 0= No symptom, 6= Death)

    Time frame: 1 year

  2. Complete aneurysm occlusion rate

    Measured by the Raymond Scale

    Time frame: 1 year

  3. Retreatment Rate

    Rate and description of aneurysm retreated or planned for retreatment

    Time frame: 1 year

  4. Patient description

    Description of the population of patients treated with FRED and FRED JR in France

    Time frame: 1 year

07

Study locations

1 site
  • CHU Grenoble Alpes
    Grenoble, 38700, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04315168
Lead sponsor
Microvention-Terumo, Inc.
Responsible party
Sponsor
First posted
Mar 19, 2020
Start date
Jun 12, 2020
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Jan 23, 2024

Study contacts

Laurent Pierot, Prof.
principal investigator · Hôpital Maison Blanche, Reims, France

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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