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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
SmartGUIDE 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.
The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.
Państwowy Instytut Medyczny MSWiA
Warsaw, Poland
RECRUITINGPerformance
Intra-procedural technical success defined as successful navigation of device to the target vessel without need for shaping by hand, removal or exchange.
Time frame: During index procedure
Usability
Usability data (shape retention, pushability, trackability, navigability, support, proximal access complexity) collected through questionnaire.
Time frame: During index procedure
Procedural times
Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).
Time frame: During index procedure
Intra-procedural adverse events
Occurrence of adverse events
Time frame: During index procedure and up to 48 hours post procedure
Intra-procedural device deficiencies
Occurrence of intraprocedural device deficiencies
Time frame: During index procedure
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