Unruptured Cerebral Aneurysm
Conditions
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.
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.
Sponsors
Artiria Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 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 vascular target vessel without need for shaping, removal or exchange. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 device deficiencies/malfunctions |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORPaolo Machi, Professor
Geneva University Hospital - HUG
Outcome results
None listed