Clinical trial NCT02921698: Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Official title: Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysms
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


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.

Primary outcomes:
measure: Aneurysm occlusion without ˃ 50% parent artery stenosis
timeFrame: 6 months
measure: Morbidity rate
timeFrame: 6 months
measure: Mortality rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU Reims; Reims, France
name: Laurent Pierot, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.