NCT07132255: tele-PCI

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

ENROLLING BY INVITATION NA Last updated 20 August 2025

What this trial tests

NA trial testing R-One assisted tele-PCI in Coronary Artery Disease (CAD) in 60 participants. Enrolling by invitation.

Timeline

14 March 2024

Primary endpoint
30 September 2025

30 September 2026

Quick facts

Lead sponsor	Cathbot (Shanghai) Robot Co., Ltd
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	14 March 2024
Primary completion	30 September 2025
Estimated completion	30 September 2026
Sites	5 locations across China

Drugs / interventions tested

• R-One assisted tele-PCI
• R-One assisted on-site PCI

Conditions studied

• Coronary Artery Disease (CAD) — all drugs for Coronary Artery Disease (CAD) →
• Percutaneous Coronary Intervention (PCI) — all drugs for Percutaneous Coronary Intervention (PCI) →

Sponsor

Cathbot (Shanghai) Robot Co., Ltd

Who can join

Adults 18 to 80, any sex, with Coronary Artery Disease (CAD) or Percutaneous Coronary Intervention (PCI). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.