Unruptured Cerebral AneurysmNCT06972966
NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)
A study testing SmartGUIDE (deflectable guidewire) in people with Unruptured Cerebral Aneurysm, run by Artiria Medical at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unruptured Cerebral Aneurysm
- What is being tested?
- SmartGUIDE (deflectable guidewire)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePoland
- Study dates
- 18 Jun 2025to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Informed consent signed by the patient
- Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- SmartGUIDE (deflectable guidewire), Any standard of care guidewire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 guidewireDevice
The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.
| Study group | Role | What they receive |
|---|---|---|
| SmartGUIDE (deflectable guidewire) | Experimental | Not described Receives: Device: SmartGUIDE (deflectable guidewire) |
| Any standard of care guidewire | Active comparator | Not described Receives: Device: Any standard of care guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Intra-procedural technical success defined as successful navigation of device to the target vessel without need for shaping by hand, removal or exchange.
Measured: During index procedure
Secondary outcomes (4)
Usability
Usability data (shape retention, pushability, trackability, navigability, support, proximal access complexity) collected through questionnaire.
Measured: During index procedure
Procedural times
Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).
Measured: During index procedure
Intra-procedural adverse events
Occurrence of adverse events
Measured: During index procedure and up to 48 hours post procedure
Intra-procedural device deficiencies
Occurrence of intraprocedural device deficiencies
Measured: During index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start18 Jun 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unruptured Cerebral AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artiria Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr hab.n.med Michał Zawadzki, Principal investigator, Państwowy Instytut Medyczny MSWiA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972966
- Sponsor's protocol ID
- PL 2024
- Status last verified
- Aug 2026
- First submitted
- 2 May 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)
- ClinicalTrials.gov ID
- NCT06972966
- Acronym / sponsor ID
- PL 2024
- Conditions
- Unruptured Cerebral Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Artiria MedicalIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmartGUIDE (deflectable guidewire) | Experimental | Device: SmartGUIDE (deflectable guidewire) |
| Any standard of care guidewire | Active comparator | Device: Any standard of care guidewire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years of age
- Informed consent signed by the patient
- Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | SmartGUIDE (deflectable guidewire) |
| Any standard of care guidewireThe control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures. | Device | Any standard of care guidewire |
Primary outcome
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.
4 secondary outcomes
Usability
Time frame: During index procedure
Procedural times
Time frame: During index procedure
Intra-procedural adverse events
Time frame: During index procedure and up to 48 hours post procedure
Intra-procedural device deficiencies
Time frame: During index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr hab.n.med Michał Zawadzki principal investigator
Państwowy Instytut Medyczny MSWiA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartGUIDE (deflectable guidewire) in people with Unruptured Cerebral Aneurysm, run by Artiria Medical at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: During index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.