Table 5

Summary of secondary endpoints

Endpoint% (n/N)
Proportion of subjects with clinically acceptable (90–100%) occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target IA at 12 months as assessed by angiography, and in whom an unplanned alternative treatment of the target IA had not been performed within 12 months71.9% (100/139)
Proportion of subjects in whom an unplanned alternative treatment of the target IA had not been performed within 12 months94.3% (132/140)
Proportion of subjects with clinically acceptable aneurysm occlusion (90–100%) of the target aneurysm at 12 months80.0% (112/140)
Incidence of ≥50% in-stent stenosis at the target IA at 12 months as assessed by angiography at the independent core laboratory4.3% (6/139)
Proportion of subjects with complete occlusion of the target aneurysm on 12 month angiography (Raymond 1)62.9% (88/140)
Incidence of FRED system procedure-related serious adverse events27.6% (40/145)
Incidence of FRED system device-related serious adverse events18.6% (27/145)
Incidence of unsuccessful delivery of the FRED1.4% (2/145)
Incidence of unsuccessful deployment of the FRED2.8% (4/145)
Incidence of migration of the FRED system implant at 12 months2.8% (4/145)
Unplanned alternative treatment on the target IA within 12 months, defined as re-treatment of the target aneurysm with an alternative treatment modality, including open repair, endovascular placement of an additional stent, or treatment of in-stent stenosis observed at the 180-day or 12-month follow-up time-points or at an unscheduled study follow-up visit5.7% (8/140)
Change in clinical and functional outcomes at 180-day follow-up, as measured by an increase in the modified Rankin Scale score compared with baseline13.9% (19/137)
Change in clinical and functional outcomes at 1-year follow-up, as measured by an increase in the modified Rankin Scale score compared with baseline11.9% (16/135)
Incidence of major stroke, as measured by NIHSS score at 12 months (and ophthalmic examination related to the target aneurysm if determined appropriate)6.2% (9/145)
Incidence of minor stroke, as measured by NIHSS score at 12 months (and ophthalmic examination related to the target aneurysm if determined appropriate)6.2% (9/145)
  • FRED, Flow Redirection Endoluminal Device; IA, intracranial aneurysm; NIHSS, National Institutes of Health Stroke Scale.