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

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ClinicalTrials.gov Identifier: NCT02921698
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

Study Description
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Brief Summary:
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms.

Condition or disease Intervention/treatment
Intracranial Aneurysms Device: FRED®

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Study Start Date : July 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : December 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
FRED® Device: FRED®
Flow Re-Direction Endoluminal Device


Outcome Measures
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Primary Outcome Measures :
  1. Aneurysm occlusion without ˃ 50% parent artery stenosis [ Time Frame: 6 months ]
  2. Morbidity rate [ Time Frame: 6 months ]
  3. Mortality rate [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921698


Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
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Principal Investigator: Laurent Pierot, Prof. CHU Reims; Reims, France
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT02921698    
Other Study ID Numbers: SAFE
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases