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History of Changes for Study: NCT02921698
Safety and Efficacy Analysis of FREDĀ® Embolic Device in Aneurysm Treatment (SAFE)
Latest version (submitted May 16, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 29, 2016 None (earliest Version on record)
2 March 21, 2017 Study Status
3 August 30, 2017 Study Status
4 November 7, 2017 Study Status
5 May 16, 2018 Recruitment Status, Study Status, IPDSharing and Contacts/Locations
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Study NCT02921698
Submitted Date:  September 29, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: SAFE
Brief Title: Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment (SAFE)
Official Title: Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2016
Overall Status: Active, not recruiting
Study Start: July 2014
Primary Completion: January 2017 [Anticipated]
Study Completion: July 2017 [Anticipated]
First Submitted: September 27, 2016
First Submitted that
Met QC Criteria:
September 29, 2016
First Posted: October 3, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 29, 2016
Last Update Posted: October 3, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Microvention-Terumo, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms.
Detailed Description:
Open or close this module Conditions
Conditions: Intracranial Aneurysms
Keywords:
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 100 [Actual]
Number of Groups/Cohorts 1
Target Follow-Up Duration: 12 Months
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
FRED®
Device: FRED®
Flow Re-Direction Endoluminal Device
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Study Officials: Pr. Laurent Pierot
Principal Investigator
CHU Reims; Reims, France
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Links:
Available IPD/Information:

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