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

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Main Authors: Jing Yang, Yuqi Fang, Yizhu Yan, Zijing Liu, Jing Xie, Ge Zhang, Zhicheng Zhang, Tienan Sun, Guangyao Zhai
Format: Artículo Open Access
Published: Wiley 2026
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author Jing Yang
Yuqi Fang
Yizhu Yan
Zijing Liu
Jing Xie
Ge Zhang
Zhicheng Zhang
Tienan Sun
Guangyao Zhai
author_facet Jing Yang
Yuqi Fang
Yizhu Yan
Zijing Liu
Jing Xie
Ge Zhang
Zhicheng Zhang
Tienan Sun
Guangyao Zhai
Jing Yang
Yuqi Fang
Yizhu Yan
Zijing Liu
Jing Xie
Ge Zhang
Zhicheng Zhang
Tienan Sun
Guangyao Zhai
collection Wiley Open Access
contents Feasibility and Safety of the ETcath200 Robotic PCI System for Complex Coronary Lesions: A Prospective Single‐Center Study Jing Yang Yuqi Fang Yizhu Yan Zijing Liu Jing Xie Ge Zhang Zhicheng Zhang Tienan Sun Guangyao Zhai Catheterization and Cardiovascular Interventions ABSTRACT 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. 10.1002/ccd.70488 http://creativecommons.org/licenses/by-nc-nd/4.0/
doi_str_mv 10.1002/ccd.70488
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publisher Wiley
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spellingShingle Feasibility and Safety of the ETcath200 Robotic PCI System for Complex Coronary Lesions: A Prospective Single‐Center Study
Jing Yang
Yuqi Fang
Yizhu Yan
Zijing Liu
Jing Xie
Ge Zhang
Zhicheng Zhang
Tienan Sun
Guangyao Zhai
Catheterization and Cardiovascular Interventions
Feasibility and Safety of the ETcath200 Robotic PCI System for Complex Coronary Lesions: A Prospective Single‐Center Study Jing Yang Yuqi Fang Yizhu Yan Zijing Liu Jing Xie Ge Zhang Zhicheng Zhang Tienan Sun Guangyao Zhai Catheterization and Cardiovascular Interventions ABSTRACT 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. 10.1002/ccd.70488 http://creativecommons.org/licenses/by-nc-nd/4.0/
title Feasibility and Safety of the ETcath200 Robotic PCI System for Complex Coronary Lesions: A Prospective Single‐Center Study
topic Catheterization and Cardiovascular Interventions
url https://onlinelibrary.wiley.com/doi/10.1002/ccd.70488