Real-time Deflectable Guidewire in Neuro-interventions Study

Artiria Medical

Status: Enrolling

Conditions: Unruptured Cerebral Aneurysm

Treatments: Device: Standard of care guidewire (different models may be used); Device: SmartGUIDE (deflectable guidewire)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05564325

2022-01

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

SmartGUIDE (deflectable guidewire)

Experimental group

Treatment:

Device: SmartGUIDE (deflectable guidewire)

Standard of care guidewire

Active Comparator group

Treatment:

Device: Standard of care guidewire (different models may be used)