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.
Single group
Robotic-assisted percutaneous coronary intervention
DevicePatients with coronary artery disease will be treated usiing the R-Star robotic system for a robotic-assisted percutaneous coronary intervention
Technical success
The technical success is defined as the rate of the robotic-assisted PCI completed without total manual conversion due to irretrievable technical issue or platform limitation leading to the inability of the devices to navigate vessel anatomy.
Clinical success
Less than 30% of residual stenosis post PCI in the lesions treated using the robotic system without target lesion failure (TLF) either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.
Absence of intra-procedural vascular complications
Absence of target lesion failure (TLF)
Absence of other device-related complications
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Robocath
Lead sponsor
Veranex Switzerland SA
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
