RecruitingNot ApplicableNCT06972966

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

Sponsor

Artiria Medical

Enrollment

30 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Unruptured Cerebral Aneurysm

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Any standard of care guidewire and a medical device called SmartGUIDE (deflectable guidewire) for people with unruptured cerebral aneurysm. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESmartGUIDE (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.

DEVICEAny standard of care guidewire

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