Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter
The objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian Flow Diverter System (FDS) in the treatment of unruptured, wide-neck saccular or fusiform, intracranial aneurysms (IAs) located on the internal carotid artery (ICA) or its branches.
• Age is ≥18 and ≤80 years at the time of consent
• Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics:
‣ Is located on the internal carotid artery or its branches
⁃ Has a wide neck (wide neck typically defined as neck width ≥ 4 millimeter (mm), or dome to neck ratio ≤ 2.0) or no discernible neck
⁃ Aneurysm is either saccular or fusiform in nature
• Has a parent vessel diameter ≥ 3.0 mm to ≤ 6.0 mm at the largest diameter
• There is documented risk-benefit of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.