- OBJECTIVE: To evaluate the safety as well as the clinical and technical effectiveness of robotic-assisted PCI. METHODS: Patients with coronary artery disease and clinical indication for percutaneous intervention were enrolled. The coronary intervention was performed with the CorPath 200 robotic system, which consists of a remote interventional cockpit, and a bedside disposable cassette that enables the operator to advance, retract, and rotate guidewires and catheters. The primary endpoints were clinical procedural success, defined as <30% residual stenosis at the completion of the robotic-assisted procedure without major adverse cardiovascular events within 30 days; and device technical success, defined as the successful manipulation of the intra-coronary devices using the robotic system only. RESULTS: A total of 164 patients were enrolled at 9 sites. PCI was completed successfully without conversion to manual operation, and device technical success was achieved in 162/164 patients (98.8%). There were no device related complications. Clinical procedural success was achieved in 160/164 patients (97.6%), while 4 (2.4%) had peri-procedural non-Q wave MI. No death, stroke, Q-wave MI, or revascularization occurred in the 30 days post-procedures. Radiation exposure for the primary operator was 95.2% lower than the levels found at the traditional table position. CONCLUSIONS: This pivotal multi-center study with a robotic-enhanced coronary intervention system demonstrated the safety and feasibility of the system. The robotic remote-control procedure met the expected technical and clinical performance, with significantly lower radiation exposure to the operator.