Feasibility and Safety of the ETcath200 Robotic PCI System for Complex Coronary Lesions: A Prospective Single-Center Study.

BACKGROUND

International robotic-assisted PCI platforms such as CorPath 200 and CorPath GRX have demonstrated procedural safety and efficacy but are limited by the absence of real-time tactile feedback and cumbersome device exchange. The ETcath200, the first domestically developed robotic PCI system in China, introduces guidewire force-sensing to provide real-time visual resistance feedback that partially compensates for the lack of direct tactile sensation, along with streamlined device exchange and an intuitive joystick-roller interface.

AIMS: This study aimed to evaluate the feasibility, safety, and procedural performance of the ETcath200 system in patients with complex coronary lesions.

METHODS

In this prospective, single-center, single-arm trial, 20 patients with AHA/ACC type B2 or C complex coronary lesions underwent PCI using the ETcath200 system. Technical success was defined as full robotic completion without any unplanned manual input (including partial manual assistance or manual conversion); clinical success as residual stenosis < 30% with TIMI 3 flow and no in-hospital major adverse cardiac events (MACE). Patients were followed for 30 days.

RESULTS

All 20 patients (mean age 63.2 ± 12.0 years; 80% male) had unstable angina and complex coronary anatomy (79.2% type C lesions; 50% bifurcation, 65% diffuse). Most procedures were performed via radial access (80%), and the majority utilized drug-eluting stents (65%). Technical success was achieved in 16 cases (80%), while four cases (20%) required manual conversion due to severe tortuosity or calcification (n = 3) or guidewire-induced dissection (n = 1; managed successfully). All patients achieved clinical success; no device failures, MACE, or serious adverse events occurred at 30 days. Mean procedure duration was 61.0 ± 23.3 min; radiation dose was 0.07 ± 0.04 mSv.

CONCLUSIONS

The ETcath200 robotic PCI system demonstrated feasibility, safety, and reliable performance in complex coronary lesions, achieving high clinical success and excellent short-term outcomes. Manual conversion was required only in anatomically challenging cases. These data support further multicenter evaluation of ETcath200 in complex coronary interventions.