RecruitingNot ApplicableNCT06972953

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

Sponsor

Artiria Medical

Enrollment

30 participants

Start Date

Jun 16, 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 study tests the SmartGUIDE, a remotely controlled deflectable guidewire designed to navigate through the brain's blood vessels (neurovasculature) more safely and precisely during procedures to treat brain aneurysms, compared to standard guidewires. Navigating the delicate and winding vessels of the brain requires high precision, and a remotely steerable wire may improve safety and success rates. Eligible participants are adults over 18 who have a confirmed unruptured brain aneurysm treatable via a catheter-based approach and who have signed informed consent; those who are pregnant, have vascular disorders causing fragile vessels, or have contraindications to contrast dye are excluded. Participation involves having the SmartGUIDE guidewire used during the standard planned aneurysm treatment procedure, with outcomes compared to a historical standard guidewire control. This summary was prepared using AI to help patients understand the study in plain language.

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.