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NCT Number: NCT06972966

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

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.

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Key information

Conditions

Unruptured Cerebral Aneurysm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Państwowy Instytut Medyczny MSWiA

Warsaw, 02-507, Poland

Location status: Recruiting

Location contact

Dr hab.n.med Michał Zawadzki

CONTACT

[email protected]

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SmartGUIDE (deflectable guidewire)

Device

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

Device

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

Primary outcomes

  1. Performance

    Time frame: 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.

Secondary outcomes

  1. Usability

    Time frame: During index procedure

    Usability data (shape retention, pushability, trackability, navigability, support, proximal access complexity) collected through questionnaire.

  2. Procedural times

    Time frame: During index procedure

    Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).

  3. Intra-procedural adverse events

    Time frame: During index procedure and up to 48 hours post procedure

    Occurrence of adverse events

  4. Intra-procedural device deficiencies

    Time frame: During index procedure

    Occurrence of intraprocedural device deficiencies

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Petit-Pierre, PhD

CONTACT

[email protected]

+41 21 522 08 44

Sponsors and collaborators

Lead sponsor

Artiria Medical

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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