EVOLVE

The objective of this study is to evaluate the safety and effectiveness of the Surpass Evolve Flow Diverter System in the treatment of unruptured intracranial (brain) aneurysms. If you choose to participate in this study, you will receive intervention with the Surpass Evolve Flow Diverter implant. There will be no randomization or blinding.

Inclusion Criteria

• Has a single unruptured target intracranial aneurysm (IA) with the following characteristics: Is located on the internal carotid artery (ICA) or its branches; Has a neck ≥ 4 mm, dome to neck ratio ≤ 2.0, or no discernible neck; Aneurysm size is ≤ 12 mm (saccular or fusiform configuration)
• Has a parent vessel diameter ≥ 2.0 mm and ≤ 5.0 mm at both the proximal and distal segments where the implant will be placed
• Has multiple increased risk factors for intracranial (IA) aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.

Exclusion Criteria

• Has an extradural target aneurysm
• Has a target aneurysm in the posterior circulation
• Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from study)

Study Requirements

The study is expected to take approximately three years to complete. If you decide to participate in this research study, you will be required to return to your doctor at one month, six months, twelve months, twenty-four months, thirty-six months. There is a possibility the study will extend out to sixty months should additional information be required after 36 months. If this is the case, you may be asked to participate in a telephone or office visit at forty-eight and sixty months following your procedure. You will have brain imaging at the time of the procedure and again at 6, 12, and 36-months post-procedure.