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.
RCT Entities:
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.
Authors: Kazim H Narsinh; Ricardo Paez; Kerstin Mueller; M Travis Caton; Amanda Baker; Randall T Higashida; Van V Halbach; Christopher F Dowd; Matthew R Amans; Steven W Hetts; Alexander M Norbash; Daniel L Cooke Journal: Neuroradiol J Date: 2021-08-16
Authors: Pedro A Lemos; Marcelo Franken; Jose Mariani; Adriano Caixeta; Breno O Almeida; Fabio G Pitta; Guy F A Prado; Stefano Garzon; Felipe Ramalho; Gabriel Albuquerque; Ivanise M Gomes; Irisvaldo S de Oliveira; Leonardo Valle; Leonardo Galastri; Breno B Affonso; Felipe Nasser; Rodrigo G Garcia Journal: Cardiovasc Diagn Ther Date: 2022-02
Authors: Graham C Collins; Achraj Sarma; Zachary L Bercu; Jaydev P Desai; Brooks D Lindsey Journal: IEEE Trans Biomed Eng Date: 2021-06-17 Impact factor: 4.756