Real-time Deflectable Guidewire in Neuro-interventions Study
NCT ID: NCT05564325
Last Updated: 2025-05-11
Study Results
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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RECRUITING
NA
75 participants
INTERVENTIONAL
2023-04-19
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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SmartGUIDE (deflectable guidewire)
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.
Standard of care guidewire
Standard of care guidewire (different models may be used)
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.
Standard of care guidewire (different models may be used)
The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.
Eligibility Criteria
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Inclusion Criteria
* Informed consent signed by patient
* Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Artiria Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Paolo Machi, Professor
Role: PRINCIPAL_INVESTIGATOR
Geneva University Hospital - HUG
Locations
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Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, Switzerland
Geneva University Hospital - HUG
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Guillaume Saliou, Prod. Dr.
Role: primary
Paolo Machi, MD
Role: primary
Other Identifiers
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2022-01
Identifier Type: -
Identifier Source: org_study_id
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