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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtiria Medical

About this trial

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 criteria

Qualifiers

>18 years of age

Informed consent signed by the patient

Confirmed cerebral unruptured aneurysm treatable via transcatheter approach

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SmartGUIDE (deflectable guidewire)
  • Any standard of care guidewire

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators