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

Launched by ARTIRIA MEDICAL · May 7, 2025

Keywords

ClinConnect Summary

The NeuroNAV Study II is a clinical trial designed to test a new guidewire called SmartGUIDE, which is used in procedures to treat unruptured cerebral aneurysms. The goal is to see if the SmartGUIDE can safely and effectively navigate through the blood vessels in the brain, comparing its performance to standard guidewires that are currently used. This study is important because it aims to improve the way doctors can reach and treat aneurysms, potentially leading to better outcomes for patients.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed unruptured cerebral aneurysm that can be treated using a specific method called transcatheter approach. Those who are pregnant, have certain vascular disorders, or other specific health issues may not be able to participate. If you join the study, you can expect to undergo a procedure using the SmartGUIDE guidewire and will be closely monitored for safety and effectiveness. This trial is not yet recruiting participants, so it’s a good idea to keep an eye out for updates if you or a family member might be interested in participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \>18 years of age
• • Informed consent signed by the patient
• • Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
• Exclusion Criteria:
• • Pregnancy or lactation
• • Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome)
• • Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures
• • Acute phase myocardial infarction or uncontrolled cardiac arrhythmia
• • Uncontrolled serum electrolyte imbalance
• • Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy
• • Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
• • Known hypersensitivity to Nickel
• • Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints