p48/64 MW HPC in Aneurysm Occlusion (PIANO): Prospective, Multicenter, Single-arm Clinical Trial to Determine Safety and Effectiveness of the Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms.
To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC flow diverter in the treatment of wide-necked intracranial aneurysms.
• Subject is ≥ 18 years
• Subject has a mRS ≤2 before the index procedure
• Subject has an unruptured or recanalized intracranial aneurysm (IA). The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the index procedure. The IA must have the following characteristics below:
‣ Saccular or fusiform morphology
⁃ Located in the internal carotid artery and its branches
⁃ Aneurysm neck ≥4 mm or dome-to-neck ratio \<2
⁃ Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA
• Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.