Safety and Feasibility of a Novel, Second-Generation Robotic-Assisted System for Percutaneous Coronary Intervention: First-in-Human Report.

Objectives: The goal of this study is to evaluate the safety and efficacy of the second-generation robotic-assisted system CorPath GRX (Corindus) for percutaneous coronary intervention (PCI).

Background: The first-generation CorPath 200 robotic-assisted system for PCI is effective, but is limited by the lack of an active robotic guide-catheter control. The CorPath GRX device enables robotic guide-catheter manipulation, in addition to guidewire and balloon/stent delivery. However, there have been no clinical data reported with this device.

Methods: Consecutive patients with demonstrated obstructive coronary artery disease (>70% stenosis) and clinical indications for PCI were treated with the CorPath GRX system and enrolled in the study. The two co-primary endpoints were clinical procedural success (final TIMI 3 flow, and <30% residual stenosis without in-hospital major adverse cardiac event) and device technical success (robotic clinical procedural success without the need for unplanned manual assistance/conversion).

Results: The study enrolled 40 subjects (65.7 ± 11.9 years; 72.5% males; 54 lesions) with a high proportion of American College of Cardiology/American Heart Association type B2/C lesions (77.8%). Clinical procedural success and device technical success rates were 97.5% (n = 39 of 40) and 90.0% (n = 36 of 40), respectively.

Conclusion: The second-generation CorPath GRX system for robotic-assisted PCI is safe and effective, and achieves high rates of clinical and technical success in a cohort of patients with complex coronary disease.