intracranial aneurysms I67.10 Q28.30
Conditions
Interventions
Group 1: Surpass Aneurysm-Embolization System
Sponsors
Surpass Medical Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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 2mm and < 6mm.
Exclusion criteria
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 treatement 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events: For all subjects enrolled into the study, the incidence of adverse events will be assessed during the procedure, immediately post-procedure and through discharge. For all subjects with a deployed device, adverse events will be assessed during the procedure, immediately post-procedure, at discharge, at thirty days and six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical Feasibility: For all subjects with a deployed device, evaluation of percent occlusion will be assessed at six months after treatment. Successful device placement will be angiographically assessed immediately post-procedure. || Neurological Status: For all subjects with a deployed device, clinical/neurological outcome will be assessed using neurological evaluations by qualified personnel after the procedure, at thirty days and six months after treatment compared to the baseline evaluation. | — |
Countries
Germany
Contacts
Public ContactMartin Bendszus
University Hospital of Heidelberg Department of Neuroradiology
Outcome results
None listed