The CathPilot: Usability and Feasibility Evaluation in Simulated-Use Endovascular Interventions.

Abstract

Endovascular treatment of complex peripheral artery disease and chronic total occlusions remains a significant challenge. This is largely due to limited distal control of devices used and reliance on proximal manipulation with conventional catheters. To bridge this gap, we previously developed the CathPilot, a modular steerable catheter that integrates a self-expanding nitinol frame for local anchoring with a real-time graphical user interface that provides cross-sectional tip position feedback alongside fluoroscopy. This study compares the CathPilot with conventional non-steerable catheters in a simulated-use, within-subjects design. Eight interventional clinicians each performed three lesion-crossing attempts per device in a silicone phantom model of human vasculature. Silicone lesions were positioned in the left superficial femoral artery. Objective endpoints included lesion-crossing success, procedure time, fluoroscopy time, and radiation dose. Subjective assessments included the System Usability Scale (SUS) for perceived usability and NASA Task Load Index (NASA-TLX) for operator workload. Combining objective performance with human-factors instruments enabled a comprehensive assessment of the CathPilot's procedural usability against conventional catheters. CathPilot achieved a 92% lesion-crossing success rate with approximately 3 × improvement compared to conventional catheters. Clinician-level and lesion-level procedure times, and fluoroscopy times were significantly lower when using the CathPilot. Similarly, the NASA-TLX workload rating was significantly lower for CathPilot. Under simulated-use conditions, these findings indicate the potential of the CathPilot system to address endovascular revascularization challenges and demonstrate the added value of precise distal tip control, tracking, and support.