FRED and FRED JR Devices for Intracranial Aneurysm Treatment

NCT ID: NCT04315168

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-12

Study Completion Date

2023-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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FRED and FRED JR

Intracranial aneurysm treatment

Intervention Type DEVICE

Other Intervention Names

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Flow Re-Direction Endoluminal Device

Eligibility Criteria

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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

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Microvention-Terumo, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Pierot, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hôpital Maison Blanche, Reims, France

Locations

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CHU Grenoble Alpes

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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FRED-EPI

Identifier Type: -

Identifier Source: org_study_id

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