Unruptured Cerebral Aneurysm
Conditions
Brief summary
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.
Interventions
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.
The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.
Sponsors
Artiria Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance | During index procedure | Intra-procedural technical success defined as successful navigation of device to the target vessel without need for shaping by hand, removal or exchange. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | During index procedure | Usability data (shape retention, pushability, trackability, navigability, support, proximal access complexity) collected through questionnaire. |
| Procedural times | During index procedure | Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition). |
| Intra-procedural adverse events | During index procedure and up to 48 hours post procedure | Occurrence of adverse events |
| Intra-procedural device deficiencies | During index procedure | Occurrence of intraprocedural device deficiencies |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORDr hab.n.med Michał Zawadzki
Państwowy Instytut Medyczny MSWiA
Outcome results
None listed