R-ONE® Robotically-Enhanced PCI Intervention Study

In the researchers' words

The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic assisted percutaneous coronary intervention. This was a prospective, single-arm, multicenter, open-label, nonrandomized study. The study protocol was approved by the institutional review boards or local ethics committees of the participating facilities, and all patients provided written informed consent. Patients with angiographic documentation of obstructive coronary artery disease and evidence of myocardial ischemia were enrolled in the study. Major inclusion criteria were stenosis of target vessel at least 50% by visual estimate, with maximal length of 34 mm and maximal diameter of 4.0 mm, that could be completely covered by a single stent. Major exclusion criteria included planned PCI or coronary artery bypass graft surgery, required treatment of more than 2 coronary artery or more than 1 lesion in each target artery, previous stent implantation within 5.0 mm of the target lesion, target lesion within 5 mm of the artery opening, planned treatment with directional or rotational atherectomy, intraluminal thrombus, severe tortuosity or calcification of the lesion or proximal to it, involvement of a bifurcation, or unprotected left main coronary artery. All patients underwent PCI with the robotic R-OneTM System (R-One Vascular Robotics, Cathbot). The system was…