Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms (SCENT)

Inclusion Criteria:

• Age 19 to 80 years
• Subject or legal representative is willing and able to give informed consent
• Subject has a single targeted intracranial aneurysm
• Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up

Exclusion Criteria:

• Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia
• Known history of life threatening allergy to contrast dye
• Known allergy to nickel, chromium cobalt, tungsten or platinum
• Subject has documented resistance to clopidogrel/Plavix
• Major surgery within previous 30 days or planned in the next 120 days after enrollment date
• Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date
• Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date
• Any previous stenting of parent artery at or proximal to the aneurysm where it would interfere with the placement and proper apposition of the device
• Any previous coiling where it would interfere with the placement and proper apposition of the device
• Platelet count less than 100,000 cells/mm3 or known platelet dysfunction
• More than one intracranial aneurysm (IA) that requires treatment within 12 months
• Asymptomatic extradural aneurysms requiring treatment
• Contraindication to CT scan or MRI
• Severe neurological deficit that renders the subject incapable of living independently
• Unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days)
• Evidence of active infection at the time of treatment
• Dementia or psychiatric problem that prevents the patient from completing required follow up
• Co-morbid conditions that may limit survival to less than 24 months
• Serum creatinine greater or equal to 2.5 mg/dL
• Female subjects who are pregnant or planning to become pregnant within the study period
• Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis
• Extra-cranial stenosis or parent vessel with stenosis greater than 50% in the area proximal to the aneurysm
• Other known serious concurrent medical conditions
• History of intracranial vasospasm not responsive to medical therapy
• Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
• Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions
• Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date
• Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
• Inability to understand the study or a history of non-compliance with medical advice
• Current use of illicit substance
• Enrollment in another trial involving an investigational product
• Subject has a need for long-term use of anticoagulants (i.e., Warfarin, Dabigatran)