The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.
Patient must be 18-75 years of age at the time of screening.
Patient must have a single ruptured or unruptured IA requiring treatment.
Patient was able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule, signed and dated an written informed consent prior to initiation of any study procedures.
Patient had an IA with characteristics unsuitable for endovascular treatment.
Patient had vessel characteristics, tortuosity or morphology which precluded safe access and support during treatment with study device.
Patient had vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
Patient had vasculitis, an intracranial tumor (except benign tumors that do not require treatment) or any other intracranial vascular malformations on presentation.
Single group
Intrasaccular Embolization Device
DeviceThis is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.The intended therapeutic effect of this device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.
The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365.
Percentage of Subjects With Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment.
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This trial is not recruiting at the moment. You can still explore other options:
