Citadel Embolization Device Study

You may not qualify if:

• Target aneurysm has been previously treated
• Target aneurysm is in any extradural location, including the extradural cavernous segment
• Has vessel characteristics, tortuosity or morphology or unfavorable aneurysm morphology (e.g., determined from baseline or preprocedure imaging, or which may be evidenced by excessive resistance felt during the procedure) that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
• Has significant intracranial atherosclerotic disease or stenosis determined from baseline or pre-procedure imaging
• If the target intracranial aneurysm is classified as ruptured, patient is neurologically unstable or has a Hunt \& Hess Score of ≥ 3
• Has a history of intracranial vasospasm not responsive to medical therapy
• 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
• Treatment with flow diverting stent implant is anticipated
• A planned, staged procedure is anticipated
• 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
• Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage
• Has a baseline mRS score ≥2
• Has a known coagulopathy or is on chronic anticoagulant therapy
• Is pregnant or intends to become pregnant during the study or is breastfeeding
• Is concurrently involved in another study that could affect outcomes of IA treatment
• +3 more criteria