First-in-human use of SmartGUIDETM steerable 0.014’’ microguidewire for the treatment of intracranial aneurysms: a prospective single-center case series

Abstract Purpose To report the first-in-human, prospective clinical evaluation of a steerable 0.014″ microguidewire SmartGUIDE™ (Artiria Medical, Switzerland) for endovascular treatment of intracranial aneurysms, assessing technical feasibility, safety, and operator-reported usability. Methods Adult patients undergoing elective treatment of unruptured intracranial aneurysms were prospectively enrolled between August 2023 and July 2024 at a single center. All procedures were performed by a senior neurointerventionalist. The primary endpoint was the device technical success, defined as successful SmartGUIDE™ navigation to a predefined anatomical target. Successful microcatheterization over the wire was a clinically meaningful secondary endpoint, together with safety, device-related adverse events, navigation time, and operator-reported usability (5-point Likert scale). Patient-specific Flow Twin ® vascular replicas were used for pre-therapeutic training to refine strategy and mitigate risks inherent to first-in-human use. Clinical and imaging follow-up was performed at 1 year. Results Five patients were included. SmartGUIDE™ successfully reached the predefined target in all procedures (5/5). Microcatheterization was achieved in four cases (4/5). Median SmartGUIDE navigation time was 7 min (IQR 4–10). No wire-related complications or device malfunctions were observed. Operators reported high device usability, with median Likert scores of 4–5/5 across all parameters. At 1-year follow-up, all aneurysms demonstrated complete and stable occlusion without neurological morbidity. Conclusion This first-in-human prospective series supports the feasibility and safety of the SmartGUIDE™ steerable 0.014″ microguidewire for the treatment of intracranial aneurysms. The study reports reliable navigation to the target without device-related malfunction or complication, favorable operator-reported usability, and highlights the value of incorporating patient-specific flow-models for pre-procedural training. Comparative studies are required to establish efficiency advantage over conventional microguidewires.