The goal of this clinical trial is to learn if the R-Star robotic system can be used safely and effectively to perform percutaneous coronary intervention (PCI) in adults with coronary artery disease who are scheduled for an elective PCI.
The main questions it aims to answer are:
* Can PCI be completed with the robotic system without needing to switch fully to manual operation because of a technical issue or system limitation? * Is the treated artery adequately opened without complications during the procedure?
Participants will:
* Have selection tests, including a medical exam, lab tests, ECG, and a review of their medical history. * Undergo PCI using the R-Star robotic system, with angiography before and after the procedure. * Have checkups before leaving the hospital and about 30 days later to monitor recovery and collect study data.
Patient ≥ 18 years old;
Patient with confirmed CAD, with indication for elective PCI;
de novo native coronary artery lesion (i.e. a coronary lesion not previously treated)
Study reference vessel diameter is between 2.5 mm and 4.0 mm by visual estimate
Planned PCI or coronary artery bypass graft (CABG) within 30 days after the study procedure.
Acute myocardial infarction within 72 hours before the study procedure.
Left ventricular ejection fraction < 30%.
Recent PCI within 72 hours, or PCI within the past 30 days with a major adverse cardiac event.
Robocath
Lead sponsor
Veranex Switzerland SA
Collaborator