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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date September 27, 2016
First Posted Date October 3, 2016
Last Update Posted Date May 17, 2018
Study Start Date July 2014
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2016)
  • Aneurysm occlusion without ˃ 50% parent artery stenosis [ Time Frame: 6 months ]
  • Morbidity rate [ Time Frame: 6 months ]
  • Mortality rate [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Official Title Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Brief Summary A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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.
Condition Intracranial Aneurysms
Intervention Device: FRED®
Flow Re-Direction Endoluminal Device
Study Groups/Cohorts FRED®
Intervention: Device: FRED®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 29, 2016)
100
Original Actual Enrollment Same as current
Actual Study Completion Date December 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02921698
Other Study ID Numbers SAFE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Microvention-Terumo, Inc.
Original Responsible Party Same as current
Current Study Sponsor Microvention-Terumo, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Laurent Pierot, Prof. CHU Reims; Reims, France
PRS Account Microvention-Terumo, Inc.
Verification Date August 2017