Real-time Deflectable Guidewire in Neuro-interventions Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Deflectable guidewire
|
Device: Deflectable guidewire
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.
|
| Active Comparator: Standard of care guidewire
|
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Performance [During index procedure]
Intra-procedural technical success defined as successful navigation of device to the vascular target vessel without need for shaping, removal or exchange.
Secondary Outcome Measures
- Usability [During index procedure]
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.
- Procedural times [During index procedure]
Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).
- Safety - intra- and postprocedural [During index procedure and up to 48 hours post procedure]
Adverse events, measured by the occurrence of adverse events
- Device Deficiencies [During index procedure]
Intraprocedural device deficiencies, measured by the occurrence of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age
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Informed consent signed by patient
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Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
Exclusion Criteria:
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Pregnancy or lactation
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Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome)
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Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures
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Acute phase myocardial infarction or uncontrolled cardiac arrhythmia
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Uncontrolled serum electrolyte imbalance
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Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy
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Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
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Known hypersensitivity to Nickel
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Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Artiria Medical
Investigators
- Principal Investigator: Paolo Machi, Professor, Geneva University Hospital - HUG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-01