Overview
The aim of the study is to assess the safe and successful use of the SmartGUIDE guidewire in neuro interventions and to compare to standard of care guidewires on the market.
Eligibility
Inclusion Criteria:
- >18 years of age
- Informed consent signed by patient
- Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
Exclusion Criteria:
- Pregnancy or lactation
- Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome)
- Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures
- Acute phase myocardial infarction or uncontrolled cardiac arrhythmia
- Uncontrolled serum electrolyte imbalance
- Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy
- Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
- Known hypersensitivity to Nickel
- Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints