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

NCT06972966 | Recruiting DMC

• 1 other identifier: PL 2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unruptured Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

• Performance

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

  During index procedure

Secondary Outcomes (4)

• Usability

  During index procedure

• Procedural times

  During index procedure

• Intra-procedural adverse events

  During index procedure and up to 48 hours post procedure

• Intra-procedural device deficiencies

  During index procedure

Study Arms (2)

SmartGUIDE (deflectable guidewire)

EXPERIMENTAL

Device: SmartGUIDE (deflectable guidewire)

Any standard of care guidewire

ACTIVE COMPARATOR

Device: Any standard of care guidewire

Interventions

Any standard of care guidewire DEVICE

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

Any standard of care guidewire

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.

SmartGUIDE (deflectable guidewire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Informed consent signed by the patient
• Confirmed cerebral unruptured aneurysm treatable via transcatheter approach

You may not qualify if:

• 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

Sponsors & Collaborators

• Artiria Medical: lead

Study Sites (1)

Państwowy Instytut Medyczny MSWiA

Warsaw, 02-507, Poland

RECRUITING

Study Officials

• Dr hab.n.med Michał Zawadzki

  Państwowy Instytut Medyczny MSWiA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Petit-Pierre, PhD

CONTACT

+41 21 522 08 44; clinical@artiria-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 15, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)