Real-time Deflectable Guidewire in Neuro-interventions Study

Study Overview
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Brief Summary
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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.

Official Title
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Real-time Deflectable Guidewire in Neuro-interventions Study

Conditions
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Unruptured Cerebral Aneurysm

Intervention / Treatment
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* Device: Deflectable guidewire
* Device: Standard of care guidewire (different models may be used)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deflectable guidewire<br> | Device: Deflectable guidewire<br>* 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.<br>|
| Active Comparator: Standard of care guidewire<br> | Device: Standard of care guidewire (different models may be used)<br>* The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | Intra-procedural technical success defined as successful navigation of device to the vascular target vessel without need for shaping, removal or exchange. | During index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During index procedure | 
| Procedural times | Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition). | During index procedure | 
| Safety - intra- and postprocedural | Adverse events, measured by the occurrence of adverse events | During index procedure and up to 48 hours post procedure | 
| Device Deficiencies | Intraprocedural device deficiencies, measured by the occurrence of adverse events | During index procedure |