Remotely controlled deflectable guidewire navigation for treating unruptured cerebral aneurysms
NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I)
This trial will test whether the SmartGUIDE remotely controlled deflectable guidewire helps doctors safely and successfully navigate blood vessels 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 (Limoges) |
| Trial ID | NCT06972953 on ClinicalTrials.gov |
What this trial studies
The study compares the SmartGUIDE remotely controlled deflectable guidewire with standard commercially available guidewires during neurovascular procedures for unruptured cerebral aneurysms. Adults with aneurysms amenable to transcatheter treatment who provide informed consent will undergo procedures using either SmartGUIDE or a standard guidewire, with procedural navigation metrics and safety events recorded. Primary outcomes focus on navigation success and device-related complications observed during the intervention. The trial is conducted at CHU Limoges and captures intra-procedural performance and immediate safety endpoints.
Who should consider this trial
Good fit: Adults over 18 with a confirmed unruptured cerebral aneurysm suitable for transcatheter treatment who can give informed consent are appropriate candidates.
Not a fit: Patients with vascular fragility (e.g., Ehlers-Danlos), prior vascular injury or stenosis in the target vessels, uncontrolled cardiac or electrolyte conditions, contraindications to contrast, nickel hypersensitivity, bleeding disorders that prevent antiplatelet/anticoagulant use, pregnancy/lactation, or enrollment in interfering investigational studies are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, SmartGUIDE could improve navigation precision and reduce procedure time or vessel injury during endovascular treatment of unruptured cerebral aneurysms.
How similar studies have performed: Early pilot work and other steerable or robotic guidewire technologies in neuro and peripheral interventions have shown promising safety and navigation results, but large randomized data are limited.
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
Limoges
- Centre Hospitalier Universitaire - CHU Limoges — Limoges, France (Recruiting)
Study contacts
- Principal investigator: Prof. Dr. Aymeric Rouchaud — Centre Hospitalier Universitaire - CHU Limoges
- Study coordinator: Guillaume Petit-Pierre, PhD
- Email: clinical@artiria-medical.com
- Phone: +41215220844
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.