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A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FRED® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FRED® | Device | Flow Re-Direction Endoluminal Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aneurysm occlusion without ˃ 50% parent artery stenosis | 6 months | |
| Morbidity rate | 6 months | |
| Mortality rate | 6 months |
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Inclusion Criteria:
Patient is aged ≥18 years
Patient has an unruptured or recanalized intracranial aneurysm :
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
Patient presents with an mRS score between 0 and 2
Patients who have already been treated with a stent or a flow diverter for another aneurysm may be included if:
Exclusion Criteria:
Patient has a known allergy to antiplatelet therapy, heparin and/or contrast medium
Patient has contraindication to antiplatelet therapy and/or heparin
Patient is pregnant and/or breastfeeding
Patient may not benefit from imaging and clinical monitoring
Patient has a medical or surgical co-morbidities limiting his/her life expectancy to less than 1 year
Patient will be treated with a flow diverter other than FRED®
Patient had an intracranial hemorrhage within the 30 days preceding treatment
Patient has an aneurysm(s) with one or more of the following characteristics:
Patient has stenosis of the aneurysm parent artery.
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Patients aged a minimum of 18 years with an unruptured or recanalized intracranial aneurysm in whom endovascular treatment has been determined the appropriate treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Pierot, Prof. | CHU Reims; Reims, France | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30297539 | Derived | 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. | |
| 29352057 |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Derived |
| 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. |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |