The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.
Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent using the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form (ICF). Health Insurance Portability and Accountability Act (HIPAA)/data protection authorization has been provided and signed by the subject or subject's LAR.
Subject is 18-75 years of age at the time of consent.
Subject has a single unruptured or ruptured IA requiring treatment. If the patient has an additional IA, the additional IA must not be deemed to require treatment within 1-year of the index procedure.
Saccular morphology
During treatment planning, it is determined that subject may need an adjunctive implant device in addition to the Artisse™ Intrasaccular Device. (Subjects who need unplanned adjunctive implant devices are not excluded.)
Subject's target aneurysm was previously treated with other devices/implants (e.g., coils) or parent artery has a stent or other obstruction that could interfere with the correct placement of the Artisse™ Intrasaccular Device.
Subject has a known active systemic bacterial infection.
Subject has anatomy or physiology considered unsuitable (e.g., vessel anomaly or disease) for endovascular treatment with the Artisse™ Intrasaccular Device by the treating physician.
Single group
Artisse™ Intrasaccular Device
DeviceIntrasaccular Device
Effectiveness: Incidence of complete aneurysm occlusion
Incidence of complete aneurysm occlusion without retreatment of the target aneurysm, recurrent subarachnoid hemorrhage (SAH) from the target aneurysm, or significant parent artery stenosis (\>50% stenosis) at 1 year post-procedure.
Safety Evaluation
The safety of the Artisse™ Intrasaccular Device will be determined based on a review of all the serious adverse events (SAEs) observed during the study.
Incidence of implant success
Proportion of subjects with device implant success at the target site
Incidence of recurrence
Proportion of subjects with angiographic aneurysmal recurrence at 1 year post-procedure
Incidence of stroke
Proportion of subjects experiencing a stroke (ischemic or hemorrhagic) within 30 days post-procedure, 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure
Change in Modified Rankin Score (mRS) compared to baseline. mRS scores can range from 0 (no symptoms) to 5 (severe disability) with a separate category of 6 added for patients who expire.
Proportion of subjects with unruptured intracranial aneurysms (IAs) experiencing improvement, deterioration, or no change in the mRS score compared to baseline through 30 days post-procedure, 180 days post procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure
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