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OpenTrials
Completed

NCT Number: NCT04315168

FRED and FRED JR Devices for Intracranial Aneurysm Treatment

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

Completed

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble Alpes

Grenoble, 38700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FRED and FRED JR

Device

Intracranial aneurysm treatment

Other names: Flow Re-Direction Endoluminal Device

Primary outcomes

  1. Mortality Rate

    Time frame: 1 year

    Percentage of patients with neurological death

  2. Morbidity Rate

    Time frame: 1 year

    Percentage of patients with major ipsilateral stroke

Secondary outcomes

  1. modified Rankin Score

    Time frame: 1 year

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

  2. Complete aneurysm occlusion rate

    Time frame: 1 year

    Measured by the Raymond Scale

  3. Retreatment Rate

    Time frame: 1 year

    Rate and description of aneurysm retreated or planned for retreatment

  4. Patient description

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Official study title

Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 19, 2020
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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