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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmartGUIDE (deflectable guidewire) | Experimental |
| |
| Any standard of care guidewire | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartGUIDE (deflectable guidewire) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance | Intra-procedural technical success defined as successful navigation of device to the target vessel without need for shaping by hand, removal or exchange. | During index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Usability data (shape retention, pushability, trackability, navigability, support, proximal access complexity) collected through questionnaire. | During index procedure |
| Procedural times |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Petit-Pierre, PhD | Contact | +41 21 522 08 44 | clinical@artiria-medical.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr hab.n.med Michał Zawadzki | Państwowy Instytut Medyczny MSWiA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Państwowy Instytut Medyczny MSWiA | Recruiting | Warsaw | 02-507 | Poland |
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| Any standard of care guidewire | Device | The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures. |
|
Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).
| During index procedure |
| Intra-procedural adverse events | Occurrence of adverse events | During index procedure and up to 48 hours post procedure |
| Intra-procedural device deficiencies | Occurrence of intraprocedural device deficiencies | During index procedure |