Safety and Feasibility of Robot-Assisted Percutaneous Coronary Intervention Using the AVIAR 2.0 System: A Prospective, Multi-Center, Single-Arm, Open, Investigator-Initiated, Post-Approval Clinical Trial.

Abstract

Background and objectives: Traditional manual percutaneous coronary intervention (PCI) exposes operators to significant radiation and physical stress. The recently developed Advanced Vascular Intervention Assist Robot (AVIAR) 2.0 system in South Korea aimed to overcome these issues by evaluating its safety and feasibility in a clinical setting.

Methods: The study enrolled patients with stable angina from 2 medical centers. Single-vessel de novo lesions were treated using the AVIAR 2.0 system. The primary endpoints were technical success (using the AVIAR system for PCI devices, including guidewires, balloon catheters, and stents, without switching to manual) and clinical success (<30% residual stenosis in the treated lesion and no major cardiovascular events within 48 hours or before discharge). Secondary endpoints included operator radiation exposure and procedural time. Safety was assessed using treatment-emergent adverse events.

Results: Twenty patients (mean age, 63.9±8.5 years, 70% male) underwent robot-assisted PCI for lesions mainly in the left anterior descending artery and right coronary artery, with 95% (19/20) classified as B2/C lesions. The average robotic procedural time was 23:06±05:55 minutes. Technical success was 100%, with no need for manual conversion. Clinical success was 100%, with no major complications until discharge. Operator effective radiation dose was reduced by 84% compared to table effective doses.

Conclusions: The AVIAR 2.0 system appears to be a safe and effective adjunct to manual PCI, enhancing procedural efficiency and reducing operator radiation exposure. These findings support the use of robotics in coronary interventions and suggest a promising future for minimally invasive cardiac procedures.

Trial registration: ClinicalTrials.gov Identifier: NCT05981859.