NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I)
Artiria Medical
30 participants
Jun 16, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- \>18 years of age
- Informed consent signed by the patient
- Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
Exclusion Criteria9
- 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
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Interventions
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.
The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06972953