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Clinical Trials in France / NCT06972953
Recruiting Not applicable

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

NCT06972953 · tracked via the Priya Life Science France tracker
Sponsor
Artiria Medical
Phase
Not applicable
Started
2025-06-16
Last updated
2026-01-21

Condition(s) studied

Unruptured Cerebral Aneurysm

Investigational drug(s) / intervention(s)

SmartGUIDE (deflectable guidewire)Any standard of care guidewire

SmartGUIDE (deflectable guidewire): 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.

Any standard of care guidewire: The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Performance — During index procedure
    Intra-procedural technical success defined as successful navigation of device to the target vessel without need for shaping by hand, removal or exchange.

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Universitaire - CHU Limoges Limoges France Recruiting

Other trials for the same condition

Comprehensive Aneurysm Management Trial Recruiting
Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06972953 on ClinicalTrials.gov ↗ ← All trials in France