Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment (SAFE)

May 16, 2018 updated by: Microvention-Terumo, Inc.
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  1. Patient is aged ≥18 years

  2. Patient has an unruptured or recanalized intracranial aneurysm :

    • for which an endovascular treatment has been determined appropriate
    • that can not be treated by standard techniques (coiling with or without remodeling)
    • and for which the FRED® Flow Diverter has been determined an appropriate treatment
  3. Patient or patient's legally authorized representative has been informed about the confidentiality of the study and agrees to the collection of his/her personal data
  4. Patient presents with an mRS score between 0 and 2

  5. Patients who have already been treated with a stent or a flow diverter for another aneurysm may be included if:

    • the previous treatment was more than three months prior to enrollment in this study
    • the aneurysm to be treated for this study is a new aneurysm located on a different parent vessel unless the stent already in place is implanted on the proximal carotid artery.

Exclusion Criteria:

  1. Patient has a known allergy to antiplatelet therapy, heparin and/or contrast medium
  2. Patient has contraindication to antiplatelet therapy and/or heparin
  3. Patient is pregnant and/or breastfeeding
  4. Patient may not benefit from imaging and clinical monitoring
  5. Patient has a medical or surgical co-morbidities limiting his/her life expectancy to less than 1 year
  6. Patient will be treated with a flow diverter other than FRED®
  7. Patient had an intracranial hemorrhage within the 30 days preceding treatment

  8. Patient has an aneurysm(s) with one or more of the following characteristics:

    • associated with an arteriovenous malformation
    • dissecting or ""blister-like""
    • multiple (unless only one aneurysm requires treatment)
    • located in the posterior circulation
    • treated with a stent or a flow diverter on the same parent vessel (excluding proximal carotid artery) or in the 3 months prior to inclusion
  9. Patient has stenosis of the aneurysm parent artery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FRED®
Device: FRED®
Flow Re-Direction Endoluminal Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality rate
Time Frame: 6 months
6 months
Morbidity rate
Time Frame: 6 months
6 months
Aneurysm occlusion without ˃ 50% parent artery stenosis
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microvention-Terumo, Inc.

Investigators

  • Principal Investigator: Laurent Pierot, Prof., CHU Reims; Reims, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAFE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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