Actively Recruiting
NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)
Led by Artiria Medical · Updated on 2026-01-21
30
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be older than 18 years
- Signed informed consent must be obtained from the patient
- Confirmed cerebral unruptured aneurysm that can be treated via a transcatheter approach
You will not qualify if you...
- Pregnancy or lactation
- Known disorders causing fragile blood vessels prone to injury, such as Ehlers-Danlos syndrome
- Prior vascular stenosis, dissection, or injury to vessels intended for catheterization during study procedures
- Acute myocardial infarction or uncontrolled cardiac arrhythmia
- Uncontrolled serum electrolyte imbalance
- Bleeding disorders limiting use of antiplatelet or anticoagulant therapy
- Known contraindication to intravascular contrast material not manageable with pre-medication
- Known hypersensitivity to Nickel
- Current enrollment in another investigational device or drug study that interferes with this study's endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Państwowy Instytut Medyczny MSWiA
Warsaw, Poland, 02-507
Actively Recruiting
Research Team
G
Guillaume Petit-Pierre, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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