NCT04315168

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 12, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

3.6 years

First QC Date

March 17, 2020

Last Update Submit

January 22, 2024

Conditions

Intracranial Aneurysm

Keywords

aneurysmendovascularflow-diverter

Outcome Measures

Primary Outcomes (2)

  • Mortality Rate

    Percentage of patients with neurological death

    1 year

  • Morbidity Rate

    Percentage of patients with major ipsilateral stroke

    1 year

Secondary Outcomes (4)

  • modified Rankin Score

    1 year

  • Complete aneurysm occlusion rate

    1 year

  • Retreatment Rate

    1 year

  • Patient description

    1 year

Interventions

FRED and FRED JRDEVICE

Intracranial aneurysm treatment

Also known as: Flow Re-Direction Endoluminal Device

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38700, France

Location

MeSH Terms

Conditions

Intracranial AneurysmAneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Laurent Pierot, Prof.

    Hôpital Maison Blanche, Reims, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 19, 2020

Study Start

June 12, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)