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| OBJECTIVES | To evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter. The study aimed to demonstrate non-inferiority in safety and effectiveness results as compared with performance goals of other already approved similar devices after a comprehensive analysis of the peer-reviewed published literature. |
| STUDY | Multicenter, prospective, single-arm, investigational device exemption clinical study initiated in 25 centers in the US and one site in Japan. |
| POPULATION | Patients with wide-necked aneurysms arising proximal to the anterior communicating segment, the middle cerebral artery M1/M2 junction, or the basilar artery bifurcation, parent artery of 2.0–5.0 mm in diameter and unfavorable morphology. |
| ENDPOINTS | The safety and efficacy goals were a priori determined and prespecified at less than 15% and greater than 46%. The primary safety endpoint of the study was the proportion of subjects who experienced death or major stroke (>4 more points on the NIHSS) within 30 days of the procedure or had any major ipsilateral stroke or neurological death within 12 months of the procedure. The primary effectiveness endpoint was the proportion of subjects with complete occlusion of the target aneurysm and less than or equal to 50% stenosis of the parent artery at the target intracranial aneurysm at 12 months after treatment as assessed by angiography, and without re-treatment of the target intracranial aneurysm within 1-year post-FRED placement. Any re-treatment was considered an endpoint failure for effectiveness. |