NCT07132255Enrolling by invitation

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

Platform Construction and Clinical Application of 5G Technology for Remote Operation of the R-One™ Robot in Percutaneous Coronary Intervention

Source: ClinicalTrials.gov · Last updated 20 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Enrolling by invitation
Study type: Interventional
Enrollment: 60 (estimated)
First submitted: 11 Aug 2025
Start date: 14 Mar 2024
Primary completion date: 30 Sept 2025
Lead sponsor: Cathbot (Shanghai) Robot Co., Ltd
Diseases: Coronary artery disease
NCT number: NCT07132255

What you commit to

Study type: Interventional
Planned participants: 60
From 14 Mar 2024 to the primary completion date, 30 Sept 2025
5 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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;
Cardiogenic shock within 48 hours prior to the PCI procedure;
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.
In-stent restenosis, or the target vessel has implanted a stent previous which in close proximity to the target lesion.

Other illness

Severe heart failure (NYHA ≥ Class III);
Subjects with allergies to aspirin, heparin, clopidogrel, contrast media, metallic materials and rapamycin;

Lab values

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;

Other

Pregnant and lactating women, or women with plans to become pregnant during the clinical trial;
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.
Need other treatments (e.g., atherectomy or laser treatment) in addition to balloon angioplasty and stentoplasty.
Coronary anatomy deemed unsuitable for robot-assisted PCI as determined by the operator.

Who the study is looking for

18 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;
2.5 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Jimsar People's Hospital Coordinator of this site? Confirm its status	Jimsar	China	Unknown status
Karamay Central Hospital of Xinjiang Coordinator of this site? Confirm its status	Karamay	China	Unknown status
The First Hospital of Kashgar Prefecture Coordinator of this site? Confirm its status	Kashgar	China	Unknown status
Luopu People's Hospital Coordinator of this site? Confirm its status	Luopu	China	Unknown status
People's Hospital of Xinjiang Uygur Autonomous Region Coordinator of this site? Confirm its status	Ürümqi	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.