Nuvascular Harbor Occlusion Device Pilot Study

Nuvascular is sponsoring a prospective, single-center, single arm clinical trial to assess the safety and effectiveness of the HARBOR Occlusion Device for the treatment of unruptured intracranial aneurysms.

Inclusion criteria

• Patient must be 18-79 years of age at the time of screening.
• Patient must have a single unruptured IA requiring treatment. If the subject has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure.
• The index IA to be treated must have the following characteristics:

• Saccular in shape
• Diameter 2.5 mm to 12.0 mm
• IA is appropriate for treatment with the HARBOR Occlusion Device per device Instructions for Use
• Patient has an IA that is appropriate for treatment with HARBOR Occlusion Device without the use of additional implanted devices
• Patient must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule. Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
• Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.

Exclusion criteria

• Patient has a ruptured IA, defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 180 days.
• Patient has an IA with characteristics unsuitable for endovascular treatment.
• Microcatheter could not reach patient's index aneurysm to allow necessary access to treat with study device.
• Patient has vessel characteristics, tortuosity or morphology which could preclude safe access and support during treatment with study device;
• Patient has vascular disease or other vascular anomaly so as to preclude the necessary access to the aneurysm for use of the study device.
• Patient has clinical, angiographic or CT evidence of vasospasm, vasculitis, or intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
• Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 60 days.
• Patient has any circulatory, neurovascular, cardiovascular, or neurologic conditions that have resulted in unstable neurological symptoms.
• Patient has mRS ≥ 2 prior to presentation
• Patient has had an SAH from a non-index IA or any other intracranial hemorrhage within 180 days.
• Patient has physical, neurologic or psychiatric conditions which preclude his/her ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
• Patient has a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
• Patient is pregnant.
• Patient has known hypersensitivity, which cannot be medically treated, to any component of the study implant device (primarily nickel-titanium alloy), procedural materials, or medications commonly used during the procedure.
• Patient is concurrently involved in another investigational study or a post-market study that could affect the safety and effectiveness of IA treatment with the study device or with the study's follow-up schedule.
• Patient has an acute life-threatening illness other than the neurological disease to be treated in this trial.
• Patient has a life expectancy of less than 2 years due to other illness or condition (in addition to an intracranial aneurysm).