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

NCT07132255 | Enrolling By Invitation DMC

• 2 other identifiers: R-One-2024112123120241121231
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief 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)

Keywords

PCI; tele-PCI; CAD

Outcome Measures

Primary Outcomes (2)

• Clinical success rate of the surgery

  Calculation formula: Clinical success rate = number of subjects that were clinical successes ÷ number of subjects that received surgical treatment × 100%. Evaluation method: The target lesion was treated with test device, and the residual stenosis in the target vessel (visual description by angiography) reduced to less than 30% after PCI and a TIMI grade of 3. No major adverse cardiovascular events (MACE) occurred in the hospital.

  Operation day

• Success rate of surgical techniques

  Calculation formula: Technical success rate = number of subjects that were technical successes ÷ number of subjects received surgical treatment × 100% Evaluation method: The Robot-assisted PCI procedure was successfully completed without any unplanned manual assistance or shift to manual operation. Definition of planned manual assistance: During robotic surgery: Reposition of guidewires or stents/balloons, manual translation/rotation of guidewires or stents/balloons to guiding catheters, reposition of guiding catheters and usage of any device that is not compatible with the robotic platform Definition of unplanned manual assistance: Manual translation/rotation of the guidewire and/or manual translation of the stent/balloon once the guidewire has left the guiding catheter Definition of the shift to manual operation: Any situation during the PCI procedure that results in the shift to manual operation. System restart failure during robotic surgery

  Operation day

Secondary Outcomes (6)

• Procedure duration

  Operation day

• Duration of robot-assisted treatment

  Operation day

• Radiation exposure to the patient

  Operation day

• Radiation exposure to surgeons

  Operation day

• Contrast dose

  Operation day

Other Outcomes (6)

• Intraoperative physiological load evaluation of surgeons

  Operation day

• Intraoperative psychological load evaluation of surgeons

  Operation day

• Intraoperative Remote Control Performance Evaluation of surgeons

  Operation day

Study Arms (2)

R-One assisted tele-PCI

EXPERIMENTAL

The investigational device was R-One Vascular Interventional Navigation Control System developed and produced by Robocath, and was composed of a platform (instruction unit, robot, support joint arm), a consumable set (cartridge, instruction unit protective sleeve), and a remote workstation. To achieve remote surgery, remote communication workstations need to be configured at all locations where remote surgery is performed. The remote communication workstation of local operating room will establish the virtual surgery, and the remote communication workstation of the remote control side needs to join the virtual surgery through the invitation code to establish remote control between the two places. After the virtual surgery is established, the two communication workstations need to incorporate the robots nearby into the operation. In this way, the two control consoles can achieve remote control and data exchange.

Device: R-One assisted tele-PCI

R-One assisted on-site PCI

ACTIVE COMPARATOR

The product is designed with a master-slave control, which inserts and retracts guidewires, balloons and stent catheters via a remote-controlled robotic arm. The surgeon inputs the movements through the handle at the master end, and the robot replicates the surgeon's hand movements from the slave end to complete the surgical operation.

Device: R-One assisted on-site PCI

Interventions

R-One assisted tele-PCI DEVICE

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

R-One assisted tele-PCI

R-One assisted on-site PCI DEVICE

Surgeons perform operations by controlling robot from local console .

R-One assisted on-site PCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age ≤ age ≤ 80 years of age.
• Have clinical indication(s) for PCI and need to be treated with a PCI procedure.
• Subjects voluntarily signed an informed consent form and were willing to complete follow-up visits.
• Visual description of target lesion diameter stenosis ≥70% (or ≥50% accompanied with clinical evidence of myocardial ischemia within that range;
• mm ≤reference vessel diameter by visual description ≤ 4.0 mm.
• Target lesion length ≤34.0 mm by visual description (If it is made up of multiple small lesions, the distance of which should not exceed 10 mm) and can be fully covered by a single stent. There are no less than 2.0 mm normal segmental vessels at the proximal and distal margins of the diseased region.
• ≤2 target vessels to be treated, one single stent for each target lesion per target vessel, and target lesions can not be treated through stages.

You may not qualify if:

• Subjects have undergone other PCI within 72 hours prior to the R-One PCI procedure;
• Subjects have undergone PCI within 30 days prior to the R-One PCI procedure and have experienced a MACE or other serious adverse event;
• Acute myocardial infarction (MI) within one week prior to scheduled R-One PCI procedure;
• Severe heart failure (NYHA ≥ Class III);
• Cardiogenic shock within 48 hours prior to the PCI procedure;
• Pregnant and lactating women, or women with plans to become pregnant during the clinical trial;
• Subjects with allergies to aspirin, heparin, clopidogrel, contrast media, metallic materials and rapamycin;
• Subjects with a platelet count \<100 x 109/L or \>700 x 109/L and a white blood cell (WBC) count \<3 x 109/L (e.g., thrombocytopenia, thrombocytosis, neutropenia or leukopenia);
• Subjects with creatinine levels ≥ 177 umol/L;
• Subjects had a stroke within 30 days prior to the planned R-One PCI procedure.
• Subjects with an active peptic ulcer or upper gastrointestinal hemorrhage within 6 months prior to the PCI procedure.
• Subjects with a history of massive haemorrhage or coagulation disorder, or refusal of blood transfusion within the previous 6 months.
• Subjects are currently enrolled in another clinical study that has not yet completed the entire follow-up period.
• The investigators determined that the patient was not applicable for robot-assisted PCI.
• TIMI blood flow grade of \<3 for the target lesion.

Sponsors & Collaborators

• Cathbot (Shanghai) Robot Co., Ltd: lead
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• Karamay Central Hospital of Xinjiang: collaborator
• The First Hospital of Kashgar Prefecture: collaborator
• Jimusar People's Hospital: collaborator
• Luopu People's Hospital: collaborator

Study Sites (5)

Jimsar People's Hospital

Jimsar, Xinjiang Uygur Autonomous Region, China

Location

Karamay Central Hospital of Xinjiang

Karamay, Xinjiang Uygur Autonomous Region, 834000, China

Location

The First Hospital of Kashgar Prefecture

Kashgar, Xinjiang Uygur Autonomous Region, 844001, China

Location

Luopu People's Hospital

Luopu, Xinjiang Uygur Autonomous Region, 848200, China

Location

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang Uygur Autonomous Region, 830094, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yining Yang

  People's Hospital of Xinjiang Uygur Autonomous Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This prospective multicenter exploratory clinical study is conducted simultaneously at one remote control center and four on-site operative centers. 60 eligible subjects are randomly allocated into either on-site R-One-assisted PCI group or R-One-assisted tele-PCI group. The surgical team will perform robot-assisted PCI procedures while researchers systematically document device performance metrics to evaluate the remote operational performance of R-One.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 20, 2025
• Study Start: March 14, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)