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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-18

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Unruptured Cerebral Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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SmartGUIDE (deflectable guidewire)

Group Type EXPERIMENTAL

SmartGUIDE (deflectable guidewire)

Intervention Type DEVICE

SmartGUIDE is 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.

Any standard of care guidewire

Group Type ACTIVE_COMPARATOR

Any standard of care guidewire

Intervention Type DEVICE

The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.

Interventions

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SmartGUIDE (deflectable guidewire)

SmartGUIDE is 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.

Intervention Type DEVICE

Any standard of care guidewire

The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \>18 years of age
* Informed consent signed by the 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No