R-ONE® Robotically-Enhanced PCI Intervention Study

Summary

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 designed for coronary PCI and consists of 2 major components: the command unit and a bedside robot. The command unit is a radiation-shielded, mobile workstation that was positioned in the corner of the catheterization laboratory. The interventional cardiologist sits at the command unit and remotely performs the PCI using the console joysticks. Commands from the control console are delivered as electrical signals along a communication cable that runs from the control console to the robotic drive, on which a sterile cassette is placed. The cassette, which is loaded with the robot and connected to the guiding catheters, imposes axial and rotational forces on the intracoronary devices. The robotic-assisted system is compatible with all commercially available 0.014-inch guidewires, rapid-exchange coronary angioplasty balloons, and stent delivery systems. Fluoro-scopic, electrocardiographic, and hemodynamic images are "slaved" to the duplicate monitors inside the cockpit, enabling visualization from a closer distance. All operators had training on the system that included either animal laboratory experience or using the device to simulate operation before enrolling patients in the study.

After completion of diagnostic angiography, the guiding catheter was positioned at the ostium of the coronary artery and connected to the disposable cassette on the robotic drive. The guidewire was loaded into the cassette before starting the robotic-enhanced PCI. The treatment plan is decided by the doctor according to the patients' situation to perform pre-dilation, stent implantation, post-dilation, or drug balloon. All intracoronary devices were to be manipulated exclusively by the robotic system, with bailout to manual conversion when needed.

The primary endpoints were clinical procedural success and device technical success. Clinical procedural success was defined as \<30% residual stenosis and Thrombolysis In Myocardial Infarction (TIMI) grade 3 at the completion of the procedure of robotically-treated lesions as determined by a quantitative coronary angiographic core laboratory, in the absence of major adverse cardiovascular events (MACE), either before hospital discharge or within 30 days of the procedure, whichever occurred first. Major adverse cardiovascular events were defined as cardiac death, Q-wave or non-Q-wave myocardial infarction, or clinically driven target vessel revascularization. All events were adjudicated by an independent clinical events committee. Device technical success was defined as the successful intracoronary advancement and retraction of the PCI devices (guidewire, balloon and stent) by the robotic system, without conversion to manual operation.

The necessary sample size for testing the endpoint of clinical and technical procedural success was calculated on the basis of the target value. The statistical analysis results show that the lower limit of the 95% confidence interval of the clinical success rate and the technical success rate of the operation is greater than 90% of the target value, and the invalid hypothesis is rejected. Both primary endpoints had to be met for the study to be declared successful. Data were analyzed on an intention-to-treat basis. Standard summary statistics were calculated for all patient and study outcome variables. Continuous variables were summarized using estimated means, standard deviations, minimums, maximums, medians, and interquartile ranges. Categorical data were summarized using frequencies, percentages, and 95% confidence interval.

Conditions

• Cardiovascular Diseases

Interventions

DEVICE

R-One vascular interventional navigation control system

The interventional cardiologist sits at the cockpit and remotely performs the PCI using the console joysticks. The cassette, which is loaded with the interventional devices and connected to the guiding catheters, imposes axial and rotational forces on the intracoronary devices. Fluoroscopic, electrocardiographic, and hemodynamic images are "slaved" to the duplicate monitors inside the cockpit, enabling visualization from a closer distance. After completion of diagnostic angiography, the guiding catheter was positioned at the ostium of the coronary artery and connected to the disposable cassette on the robotic drive. The guidewire was loaded into the cassette. Treatment was administrated according to local site protocols. Pre and post dilation was done per operator discretion. All intracoronary devices were to be manipulated exclusively by the robotic system, with bailout to manual conversion when needed.

Sponsors & Collaborators

• Chinese PLA General Hospital

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• Shanxi Cardiovascular Hospital

  collaborator OTHER

• Meizhou People's Hospital

  collaborator OTHER

• Peking University

  collaborator OTHER

• Cathbot (Shanghai) Robot Co., Ltd

  lead INDUSTRY

Principal Investigators

• Yundai Chen · Chinese PLA General Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-23

Primary Completion

2022-05-26

Completion

2022-06-20

Countries

• China

Study Locations