Not provided
Not provided
Not provided
Not provided
Not provided
The study was prematurely terminated after the successful completion of the pilot phase and the EU CE marking was obtained, rendering the continuation no longer necessary. The study was not terminated for reasons related to participants' safety.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmartGUIDE (deflectable guidewire) | Experimental |
|
| 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 vascular target vessel without need for shaping, removal or exchange. | During index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | 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. | During index procedure |
| Procedural times |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paolo Machi, Professor | Geneva University Hospital - HUG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospital - HUG | Geneva | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition). |
| During index procedure |
| Safety - intra- and postprocedural | Adverse events, measured by the occurrence of adverse events | During index procedure and up to 48 hours post procedure |
| Device Deficiencies | Intraprocedural device deficiencies, measured by the occurrence of device deficiencies/malfunctions | During index procedure |