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TerminatedNCT05564325Updated Apr 13, 2026

Real-time Deflectable Guidewire in Neuro-interventions Study

An interventional study of SmartGUIDE (deflectable guidewire) in Unruptured Cerebral Aneurysm, sponsored by Artiria Medical. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Artiria Medical · Not applicable, Interventional, and Other

Why this study was terminated
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.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Unruptured Cerebral Aneurysm
03

In context

Lead sponsor

Artiria Medical is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    SmartGUIDE (deflectable guidewire)

    Device: SmartGUIDE (deflectable guidewire)

Interventions

  • DeviceSmartGUIDE (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.

06

What researchers measure

Primary outcomes

  1. Performance

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

    Time frame: During index procedure

Secondary outcomes

  1. 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.

    Time frame: During index procedure

  2. Procedural times

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

    Time frame: During index procedure

  3. Safety - intra- and postprocedural

    Adverse events, measured by the occurrence of adverse events

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

  4. Device Deficiencies

    Intraprocedural device deficiencies, measured by the occurrence of device deficiencies/malfunctions

    Time frame: During index procedure

07

Study locations

1 site
  • Geneva University Hospital - HUG
    Geneva, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05564325
Lead sponsor
Artiria Medical
Responsible party
Sponsor
First posted
Oct 3, 2022
Start date
Apr 19, 2023
Primary completion
Mar 10, 2026
Completion
Mar 10, 2026
Last update
Apr 13, 2026

Study contacts

Paolo Machi, Professor
principal investigator · Geneva University Hospital - HUG

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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