Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

The primary effectiveness endpoint has three components: 1) complete occlusion of the target aneurysm assessed by a core laboratory utilizing the Raymond-Roy Scale 2) ≤ 50% stenosis of the parent artery at the target (IA) using the Warfarin-Aspirin Symptomatic Intracranial Disease(WASID) criterion which is defined as greater than 50% luminal loss, 3) alternative treatment of the target IA is 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. The Raymond-Roy Occlusion Classification has 3 responses, where Grade I is complete occlusion, no flow of contrast seen in the sac, Grade II is partial occlusion, some flow in the neck or sac, and Grade III is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.

A major stroke is defined as a new neurological event that persists for > 24 hours and results in a ≥ 4 points increase in the NIHSS score compared to baseline or compared to any subsequent lower score. A major ipsilateral stroke is defined as that occurring within the vascular distribution of the stented artery. Neurologic death is defined as a death which has been adjudicated by the independent clinical events committee to have directly resulted from a neurologic cause.The NIHSS score ranges from 0 (no stroke symptoms) to 42 (severe stroke). mRS is 6 point assessment scale used to assess disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. The mRS score ranges from 0 (no disability) to 6 (death).

Complete occlusion of the target aneurysm assessed by a core laboratory. The Raymond-Roy class is an angiographic classification scheme for grading the occlusion (closure) of endovascularly treated intracranial aneurysms: class I: complete obliteration, class II: residual neck, class III: residual aneurysm.

Stenosis of the parent artery at the target IA using the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) criterion which is defined as greater than 50% luminal loss

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

This endpoint has three components: 1) clinically acceptable occlusion of the target aneurysm assessed by a core laboratory as percent occlusion (90%-100%) 2) ≤ 50% stenosis of the parent artery at the target IA using the WASID criterion which is defined as greater than 50% luminal loss, 3) alternative treatment of the target IA is 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. The Raymond-Roy scale has 3 responses, where Grade I is complete occlusion, no flow of contrast seen in the sac, Grade II is partial occlusion, some flow in the neck or sac, and Grade III is incomplete occlusion, apparent flow into the sac.

Inability to deliver a FRED device to the target location

A serious adverse event is any medical experience regardless of its relationship to the study treatment that occurs during participant enrollment in this trial that results in any of the following: (1) inpatient hospitalization or prolongation of a hospitalization; (b) persistent or significant disability or incapacity; (c) death of the study participant, or (d) necessitates an intervention to prevent a permanent impairment of a body function or permanent damage to a body structure. Procedure related events were associated with the index procedure, antiplatelet therapy, or follow up angiography.