Neurovascular navigation with a remotely controlled deflectable guidewire
NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)
This study will test whether the SmartGUIDE remotely controlled deflectable guidewire navigates safely and successfully through brain blood vessels compared with standard guidewires in adults undergoing transcatheter treatment for unruptured cerebral aneurysms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Artiria Medical Industry-sponsored |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT06972966 on ClinicalTrials.gov |
What this trial studies
This interventional study compares the SmartGUIDE deflectable guidewire to standard-of-care guidewires during endovascular treatment of unruptured cerebral aneurysms. Adults eligible for transcatheter aneurysm treatment and able to provide informed consent will be enrolled and undergo procedures at the study center. The primary focus is on navigation performance and safety within the neurovasculature, with procedural outcomes and device-related complications recorded. Standard inclusion and exclusion criteria (e.g., pregnancy, vascular fragility, contrast contraindication) are applied to protect participant safety.
Who should consider this trial
Good fit: Adults over 18 with a confirmed unruptured cerebral aneurysm that can be treated via a transcatheter approach and who can give informed consent are the ideal candidates.
Not a fit: Patients who are pregnant, have known vascular fragility or prior vascular injury in target vessels, have contraindications to contrast or antiplatelet therapy, or are otherwise excluded by the trial criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the SmartGUIDE may make catheter navigation through brain vessels easier and safer, potentially reducing procedure time and complications.
How similar studies have performed: Remotely controlled deflectable guidewires are an emerging technology with limited published neurovascular trials, though related devices have shown feasibility in other vascular territories.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Warsaw
- Państwowy Instytut Medyczny MSWiA — Warsaw, Poland (Recruiting)
Study contacts
- Principal investigator: Dr hab.n.med Michał Zawadzki — Państwowy Instytut Medyczny MSWiA
- Study coordinator: Guillaume Petit-Pierre, PhD
- Email: clinical@artiria-medical.com
- Phone: +41 21 522 08 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.