Status:
RECRUITING
NEUROvascular NAVgation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)
Lead Sponsor:
Artiria Medical
Conditions:
Unruptured Cerebral Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 successfu...
Eligibility Criteria
Inclusion
- \>18 years of age
- Informed consent signed by the patient
- Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
Exclusion
- 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
Key Trial Info
Start Date :
June 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06972966
Start Date
June 18 2025
End Date
December 1 2026
Last Update
October 2 2025
Active Locations (1)
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1
Państwowy Instytut Medyczny MSWiA
Warsaw, Poland, 02-507