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

Launched by ARTIRIA MEDICAL · May 7, 2025

Keywords

ClinConnect Summary

The NEUROvascular NAVgation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I) is a clinical trial designed to test a new type of guidewire called SmartGUIDE. This study aims to see if the SmartGUIDE can safely and effectively navigate through blood vessels in the brain, specifically for treating unruptured cerebral aneurysms. Researchers will compare the performance of the SmartGUIDE with the standard guidewires currently used in medical practice.

To participate in this trial, individuals must be at least 18 years old and have a confirmed unruptured cerebral aneurysm that can be treated with a specific method involving a catheter. However, certain people are not eligible, including those who are pregnant, have specific vascular conditions, or certain heart problems. Those who join the study will help doctors learn more about the new guidewire's safety and effectiveness, which could lead to better treatment options in the future. It's important to know that this trial is not yet recruiting participants, so interested individuals will need to check back later for updates.

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