Aneurysm
Conditions
Brief summary
The purpose of this study is to evaluate safety and performance of the Surpass Aneurysm-Embolization System.
Interventions
DEVICEAneurysm-Embolization System
Sponsors
Surpass Medical Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject understands the nature of the procedure and provides written informed consent. * Subject is willing to return to the investigational site for the thirty day and six month follow-up evaluations. * Age 18 years to 80 years. * Subject with a non-ruptured saccular, or fusiform intracranial aneurysm arising from a parent vessel with a diameter of \> 2mm and \< 6mm.
Exclusion criteria
* Pregnancy * Enrollment in another trial * Allergy or contraindication to aspirin, clopidogrel, heparin, local or general anesthesia * History of life threatening allergy to contrast dye. * Major surgery within previous 30 days or planned in the next 90 days after enrollment date. * Severe neurological deficit that renders the patient incapable of living independently * Dementia or psychiatric problem that prevents the patient from completing required follow up * Co-morbid conditions that may limit survival to less than one year * Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy. * Subject with an intracranial mass (tumor (except meningioma), abscess, or other infection), 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 has a serum creatinine level greater than 2.0 mg/dL (within 7 days of procedure) which the investigator determines restricts the use of contrast agents. * Subject has a previously implanted intracranial stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date * Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to enrollment date * Subject has a previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date * Subject has uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms. * Subject had a subarachnoid hemorrhage within 12 weeks prior to the enrollment date. * Subject with resistance to ASA and/or Clopidogrel. * Subject with two or more aneurysms in associated distribution - unless the device is used to treat both aneurysms. * Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm. * Target aneurysm is expected to require more than one device.
Outcome results
None listed