The Efficacy and Safety Evaluation of 5G Tele-PCI Using R-OneTM

Summary

Patients with coronary artery disease requiring PCI treatment were enrolled in the study.

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. Fluoro-scopic, 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 before starting the robotic-enhanced PCI. The treatment plan is decided by the doctor according to the patients' situation. 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. 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

• Coronary Artery Disease (CAD)
• Percutaneous Coronary Intervention (PCI)

Interventions

DEVICE

R-One assisted tele-PCI

Surgeons perform operations using R-One vascular interventional navigation control system from remote control center via 5G. robotic slave executes at procedure site.

DEVICE

R-One assisted on-site PCI

Surgeons perform operations by controlling robot from local console .

Sponsors & Collaborators

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• Karamay Central Hospital of Xinjiang

  collaborator UNKNOWN

• The First Hospital of Kashgar Prefecture

  collaborator UNKNOWN

• Jimusar People's Hospital

  collaborator UNKNOWN

• Luopu People's Hospital

  collaborator UNKNOWN

• Cathbot (Shanghai) Robot Co., Ltd

  lead INDUSTRY

Principal Investigators

• Yining Yang · People's Hospital of Xinjiang Uygur Autonomous Region

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-14

Primary Completion

2025-09-30

Completion

2026-09-30

Countries

• China

Study Locations