NCT06972966

NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Artiria Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unruptured Cerebral Aneurysm

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Any standard of care guidewire	The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-05-15
• Last updated: 2026-01-21

Locations

1 site across 1 country: Poland