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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
5
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.
Geneva University Hospital - HUG
Geneva, Switzerland
Performance
Intra-procedural technical success defined as successful navigation of device to the vascular target vessel without need for shaping, removal or exchange.
Time frame: During index procedure
Usability
Usability data (pushability, trackability, navigatability, shape retention, support, and proximal access complexity) collected through questionnaire completed by the physician. Measured through a Likert scale from 1-5.
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
Safety - intra- and postprocedural
Adverse events, measured by the occurrence of adverse events
Time frame: During index procedure and up to 48 hours post procedure
Device Deficiencies
Intraprocedural device deficiencies, measured by the occurrence of device deficiencies/malfunctions
Time frame: During index procedure
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