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

• ClinicalTrials.gov Identifier: NCT02921698
• Recruitment Status: Completed
• First Posted: October 3, 2016
• Last Update Posted: May 17, 2018
• Sponsor: Microvention-Terumo, Inc.
• 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
• 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 *

• Pierot L, Spelle L, Berge J, Januel AC, Herbreteau D, Aggour M, Piotin M, Biondi A, Barreau X, Mounayer C, Papagiannaki C, Lejeune JP, Gauvrit JY, Derelle AL, Chabert E, Costalat V. SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results. J Neurointerv Surg. 2019 Feb;11(2):184-189. doi: 10.1136/neurintsurg-2018-014261. Epub 2018 Oct 8.
• Pierot L, Spelle L, Berge J, Januel AC, Herbreteau D, Aggour M, Piotin M, Biondi A, Barreau X, Mounayer C, Papagiannaki C, Lejeune JP, Gauvrit JY, Costalat V. Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE study. J Neurointerv Surg. 2018 Aug;10(8):765-770. doi: 10.1136/neurintsurg-2017-013559. Epub 2018 Jan 19.

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

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