APEX-FIH is a first-in-human, open-label prospective multicenter study of the TrelliX Embolic Coil System for use in embolization of the medium to large, ruptured or unruptured cerebral aneurysms

Inclusion Criteria:

• Subject age ≥18 and ≤80 years with a diagnosis of a ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
• Aneurysm size [largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen) ≥5 mm and ≤16mm
• If ruptured aneurysm: either WFNS grade 1 or 2, or Hunt and Hess 1 or 2
• If unruptured aneurysm: Subject grade Modified Rankin Scale mRS 0 - 2
• Investigator plans to use ≥70% in volume TrelliX coils to fill target aneurysm

Exclusion Criteria:

• Prior treatment (surgical or endovascular) of the target aneurysm
• Planned treatment of multiple aneurysms in index procedure
• Planned use of other modified coils (Matrix, HydroCoil or fibered coils)
• Planned use of liquid embolic material
• Life expectancy less than 12 months
• Presence of arteriovenous malformation
• Fusiform, mycotic, traumatic, or tumoral aneurysms
• Intended or planned aneurysm treatment by parent vessel occlusion
• Clipping or endovascular treatment of another intracranial aneurysm performed within 30 days before or planned within 30 days following the index procedure](streamdown:incomplete-link)