First in Human Trial of R-Star: A Novel Robotic System for Minimally Invasive Coronary Artery Procedures.

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ClinConnect Summary

This clinical trial is testing a new robotic system called R-Star to see if it can safely and effectively help doctors open blocked heart arteries in adults with coronary artery disease. The procedure, called percutaneous coronary intervention (PCI), is usually done by hand, but this study wants to find out if the robot can perform it without problems and if it can successfully open the artery without causing complications.

Adults between the ages of 65 and 74 who are already scheduled for a planned PCI might be eligible to join. Before the procedure, participants will have some tests like a medical exam, blood work, and heart monitoring to make sure they qualify. During the study, the R-Star robot will be used to perform the artery-opening procedure, with imaging done before and after to check the results. Afterward, participants will have follow-up visits before leaving the hospital and about a month later to make sure they are healing well and to gather information about how the robot performed. The trial is not yet recruiting participants but aims to learn if this robotic system could be a safe and helpful tool for treating coronary artery disease in the future.

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