The aim of the study is to confirm the safe and successful use of the SmartGUIDE guidewire, when used in neuro interventions. The performance of the SmartGUIDE guidewire in terms of safe and successful navigation within the neurovasculature will be compared to standard of care guidewire on the market.
>18 years of age
Informed consent signed by the patient
Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
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
Parallel
SmartGUIDE (deflectable guidewire)
DeviceSmartGUIDE is a deflectable guidewire for use in interventional procedures in the neurovasculature and the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. The device is a steerable guidewire with a deflectable tip. This allows adjusting the shape of the tip, dynamically, while the physician navigates the device in the patient's arterial and venous circulatory system.
Any standard of care guidewire
DeviceThe control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.
Performance
Intra-procedural technical success defined as successful navigation of device to the target vessel without need for shaping by hand, removal or exchange.
Usability
Usability data (shape retention, pushability, trackability, navigability, support, proximal access complexity) collected through questionnaire.
Procedural times
Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).
Intra-procedural adverse events
Occurrence of adverse events.
Intra-procedural device deficiencies
Occurrence of intra-procedural device deficiencies.
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