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RECRUITINGNA

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

NCT06972966•Artiria Medical

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Państwowy Instytut Medyczny MSWiA

Warsaw, Poland

Key Dates

Start Date

June 18, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

January 21, 2026

Enrollment

ESTIMATED participants

Conditions

Unruptured Cerebral Aneurysm

Interventions

SmartGUIDE (deflectable guidewire)

DEVICE

Any standard of care guidewire

DEVICE

Contacts

Guillaume Petit-Pierre, PhD

CONTACT

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

AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction

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Unruptured Cerebral AneurysmArtificial Intelligence (AI)+2 more

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WITHDRAWNNA

Remote Ischemic PreConditioning (RIPC)

NCT03814850

Unruptured Cerebral Aneurysm

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UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction

Remote Ischemic PreConditioning (RIPC)

Chinese Small Intracranial Aneurysm Study (CSIAS)

Aspirin Attenuates Inflammation in Human Cerebral Aneurysms