RT Journal Article
SR Electronic
T1 Brazilian FRED Registry: A Prospective Multicenter Study for Brain Aneurysm Treatment—The BRED Study
JF American Journal of Neuroradiology
JO Am. J. Neuroradiol.
FD American Society of Neuroradiology
SP 1822
OP 1826
DO 10.3174/ajnr.A7258
VO 42
IS 10
A1 L.B. Manzato
A1 R.B. Santos
A1 P.M.M. Filho
A1 G. Miotto
A1 A.M. Bastos
A1 J.R. Vanzin
YR 2021
UL http://www.ajnr.org/content/42/10/1822.abstract
AB BACKGROUND AND PURPOSE: The development of flow diverters has changed the endovascular approach to intracranial aneurysms. On the basis of good results, the indications for flow diverters have expanded to include aneurysms of different shapes, locations, and sizes. The objective of the study was to report on the performance of the Flow Re-Direction Endoluminal Device (FRED) in intracranial aneurysm treatment at early and medium-term follow-up.MATERIALS AND METHODS: This single-arm, multicentric, prospective, observational study assessed aneurysm treatment with the FRED. The primary outcome was complete aneurysm occlusion at 6 and 12 months, and the secondary outcome was to evaluate the safety of the FRED with respect to stroke and death rates.RESULTS: Between June 2016 and August 2018, a total of 100 consecutive patients with 131 aneurysms were treated in 107 procedures. Total occlusion rates were 91% and 95% at 6 and 12 months. There was 1 death, and the total final morbidity rate was 1.8%. The complication rate was 4.6%.CONCLUSIONS: As reported previously, the FRED has proved to be a safe and effective tool, with high occlusion rates. The design of the stent makes it more difficult to perform balloon angioplasty compared with similar devices. A branch arising from the aneurysm sac was found to be a predictor of nonocclusion at 12 months, though larger series are needed to estimate the magnitude of the association.FDflow diverterFREDFlow Re-Direction Endoluminal Device