Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms

Efficacy and Safety of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms : a Prospective, Multicenter, Single-arm Trial

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Patient was taking anticoagulants or had a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
• Patient was pregnant.