localised bulging / ballooning of a blood vessel
Conditions
Interventions
Treatment with the Surpass Aneurysm-Embolization System
Sponsors
Surpass Medical Ltd
Eligibility
Age
18 Years to 99 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 80 years. •Subject with a non-ruptured saccular, dissecting or fusiform intracranial aneurysm arising from a parent vessel with a diameter of >= 2mm and
Exclusion criteria
Exclusion criteria: •Pregnancy and lactating women •Participation in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study •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. •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 |
|---|---|
| The adverse events assessment for all enrolled subjects in the study includes: •Incidence of adverse events assessed during the procedure, immediately post-procedure through discharge. The adverse event assessment for all subjects with a deployed device includes: •Incidence of adverse events assessed during the procedure, immediately post-procedure, at discharge, at thirty days and six months after treatment. The neurological status for all subjects with a deployed device includes: •Clinical/neurological outcome using neurological evaluations (NIH Stroke Scale, Modified Rankin Scale) by qualified personnel after the procedure, at thirty days and six months after treatment compared to the baseline evaluation. The technical feasibility for all subjects with a deployed device includes: •Evaluation of percent occlusion assessed at six months after treatment. •Successful stent placement (device success defined as device placed where intended with appropriate wall apposition) angiographically assessed immediately post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| none | — |
Countries
Netherlands
Outcome results
None listed