Unruptured Cerebral AneurysmNCT05564325
Real-time Deflectable Guidewire in Neuro-interventions Study
A study testing SmartGUIDE (deflectable guidewire) in people with Unruptured Cerebral Aneurysm, run by Artiria Medical at 1 site in Switzerland.
Trial summary
The aim of the study is to assess the safe and successful use of the SmartGUIDE guidewire in neuro interventions and to compare to standard of care guidewires 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
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Apr 2023to 10 Mar 2026
- 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 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 assess the safe and successful use of the SmartGUIDE guidewire in neuro interventions and to compare to standard of care guidewires on the market.
- Conditions
- Unruptured Cerebral Aneurysm
- Being tested
- SmartGUIDE (deflectable 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.
| Study group | Role | What they receive |
|---|---|---|
| SmartGUIDE (deflectable guidewire) | Experimental | Not described Receives: Device: SmartGUIDE (deflectable 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 vascular target vessel without need for shaping, removal or exchange.
Measured: During index procedure
Secondary outcomes (4)
Usability
Usability data (pushability, trackability, navigatability, shape retention, support, and proximal access complexity) collected through questionnaire completed by the physician. Measured through a Likert scale from 1-5.
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
Safety - intra- and postprocedural
Adverse events, measured by the occurrence of adverse events
Measured: During index procedure and up to 48 hours post procedure
Device Deficiencies
Intraprocedural device deficiencies, measured by the occurrence of device deficiencies/malfunctions
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 posted3 Oct 2022
- Study start19 Apr 2023
- Primary completion10 Mar 2026
- Study completion10 Mar 2026
Why it stopped: The study was prematurely terminated after the successful completion of the pilot phase and the EU CE marking was obtained, rendering the continuation no longer necessary. The study was not terminated for reasons related to participants' safety.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artiria Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paolo Machi, Professor, Principal investigator, Geneva University Hospital - HUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564325
- Sponsor's protocol ID
- 2022-01
- Status last verified
- Apr 2026
- First submitted
- 29 Sep 2022
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Deflectable Guidewire in Neuro-interventions Study
- ClinicalTrials.gov ID
- NCT05564325
- Acronym / sponsor ID
- 2022-01
- Conditions
- Unruptured Cerebral Aneurysm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated after the successful completion of the pilot phase and the EU CE marking was obtained, rendering the continuation no longer necessary. The study was not terminated for reasons related to participants' safety.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Artiria MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 3 Oct 2022 (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 assess the safe and successful use of the SmartGUIDE guidewire in neuro interventions and to compare to standard of care guidewires on the market.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartGUIDE (deflectable guidewire) | Experimental | Device: SmartGUIDE (deflectable 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 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) |
Primary outcome
Performance
Time frame: During index procedure
Intra-procedural technical success defined as successful navigation of device to the vascular target vessel without need for shaping, removal or exchange.
4 secondary outcomes
Usability
Time frame: During index procedure
Procedural times
Time frame: During index procedure
Safety - intra- and postprocedural
Time frame: During index procedure and up to 48 hours post procedure
Device Deficiencies
Time frame: During index procedure
Results and safety
The study was stopped early (reason given: The study was prematurely terminated after the successful completion of the pilot phase and the EU CE marking was obtained, rendering the continuation no longer necessary. The study was not terminated for reasons related to participants' safety.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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.
Paolo Machi, Professor principal investigator
Geneva University Hospital - HUG
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 Switzerland.
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: stopped early, as of the sponsor's last update on 13 Apr 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 Switzerland. 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 was stopped early (reason given: The study was prematurely terminated after the successful completion of the pilot phase and the EU CE marking was obtained, rendering the continuation no longer necessary. The study was not terminated for reasons related to participants' safety.). Results are not available in the source record.
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 13 Apr 2026.