Evaluation of the R-One Robotic System for Coronary Angioplasty in Adults with Coronary Artery Disease An Observational Study on Safety and Performance in Real-World Percutaneous Coronary Intervention

What this Trial Is About

Researchers are evaluating the real-world performance and safety of the R-One System, a robotic device designed to assist in Percutaneous Coronary Intervention PCI for patients with coronary artery disease. This single-arm, open-label, multi-center registry aims to confirm the safety, performance, and clinical benefit of the R-One system across up to 15 centers in Europe and South Africa. The study will include 500 adult patients with clinical indications for PCI. Participants will undergo robotic-assisted PCI using the R-One system, which remotely delivers and manipulates coronary guidewires and stent or balloon devices under the operators control. The system includes the R-One Robotic Platform, a Mobile Radioprotection Screen, and a sterile, single-use consumable kit. Procedures will follow routine hospital practices, current guidelines, and manufacturer instructions. During the study, researchers will assess clinical and technical success of PCI from day 0 to day 3 and during the procedure. They will also monitor radiation exposure to patients and operators, procedure time, contrast volume, fluoroscopy time, and any safety events occurring up to three days post-procedure. Participation involves monitoring during and shortly after PCI to evaluate outcomes and safety.

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