Trenza Embolization Device for Intrasaccular Aneurysm Treatment

Exclusion Criteria

• •1. Target aneurysm has been previously treated.
• •2. Has significant atherosclerotic stenosis, significant vessel tortuosity, vasospasm refractory to medication, unfavorable aneurysm morphology or vessel anatomy, or some other condition(s) that, prevents or interferes with access to the target aneurysm.
• •3. Has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment or has a non-target intracranial aneurysm that is expected to be treated within 12 months following the treatment of the target aneurysm.
• •4. Treatment with flow diverting stent implant is anticipated.
• •5. A planned, staged procedure is anticipated.
• •6. Has Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), intracranial hematoma(s), any other intracranial vascular malformation, or any previous major intracranial surgery.
• •7. Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage.
• •8. Has a baseline mRS score ≥2 at time or presentation or prior to rupture (as applicable)
• •9. Has a known coagulopathy or is on chronic anticoagulant therapy.
• •10. Is pregnant or intends to become pregnant during the study or is breastfeeding.
• •11. Is concurrently involved in another study that could affect outcomes of IA treatment.
• •12. Has evidence of active cancer, terminal illness, high risk of embolic stroke, atrial fibrillation, significant co-morbidities, major surgery ≤ 30 days pre-procedure, psychiatric disorders, substance abuse, or a life expectancy of less than 5 years.
• •13. Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure.
• •14. Patient presents a Hunt and Hess grade III or more for a ruptured aneurysm.