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NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)
Sponsor: Artiria Medical
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-06-18
Completion Date
2026-12
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
SmartGUIDE (deflectable guidewire)
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.
Any standard of care guidewire
The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.
Locations (1)
Państwowy Instytut Medyczny MSWiA
Warsaw, Poland