Coronary Artery Disease (CAD)tele-PCINCT07132255
The Efficacy and Safety Evaluation of 5G Tele-PCI Using R-OneTM
A study testing R-One assisted tele-PCI and R-One assisted on-site PCI in people with Coronary Artery Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by Cathbot (Shanghai) Robot Co., Ltd at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
- What is being tested?
- R-One assisted tele-PCI and R-One assisted on-site PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesChina
- Study dates
- 14 Mar 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
- In-stent restenosis, or the target vessel has implanted a stent previous which in close proximity to 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Jimsar People's Hospital
Jimsar, Xinjiang Uygur Autonomous Region
Karamay Central Hospital of Xinjiang
Karamay, Xinjiang Uygur Autonomous Region, 834000
The First Hospital of Kashgar Prefecture
Kashgar, Xinjiang Uygur Autonomous Region, 844001
Luopu People's Hospital
Luopu, Xinjiang Uygur Autonomous Region, 848200
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region, 830094
About this study
Official title: Platform Construction and Clinical Application of 5G Technology for Remote Operation of the R-One™ Robot in Percutaneous Coronary Intervention
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.
Read more
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.
Read the detailed description
- Purpose To evaluate the effectiveness and safety of 5G-enabled remote control of the R-OneTM vascular interventional navigation control system for percutaneous coronary interventions.
- Research design A prospective, multicenter, exploratory clinical trial. Subjects who met the inclusion criteria and did not meet the exclusion criteria were enrolled into the clinical study, and the subjects are randomly grouped by using the interactive web response system (IWRS) applet (MedLand Centralized Randomization Management System). The surgeons completed the robotic-assisted surgical operation using the investigational device during cardiovascular PCI treatment. The investigator is also required to evaluate the performance of the investigational device during the procedure and ultimately determine the safety and efficacy of its clinical application.
- Device 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.
- Scope of Trial The subjects scope of the clinical trial: Patients requiring cardiovascular PCI.
- Experimental Procedure Information of all the patients who have signed the Informed Consent Form and actually pass the screening will be registered in the screening/enrollment log sheet. If a subject is excluded from the trial, the investigator should specify the reasons for screening failure. If a subject is enrolled in the trial but does not use the investigational device, the reason should also be recorded.
All subjects enrolled in the trial will be given a corresponding enrollment number.
72-hour pre-operative collected ECG, cardiac enzyme, and concomitant medication records.
Operation day visit The investigator is also required to complete the cardiology robot-assisted surgical treatment using the investigational device and record the procedure, LED Scale, SME Scale, and device Performance Evaluation Pre-discharge visit The investigator shall collect the blood test, creatinine, ECG. cardiac enzyme, concomitant medication records.
1 month post-operative visit The investigator shall collect the concomitant medication records.
Application method of the investigational device Subjects who meet the inclusion criteria and do not meet the exclusion criteria will be enrolled in the clinical study and the surgeon will complete the therapeutic treatment on the subject while performing the cardiology PCI procedure.
The investigational devices should be used by investigators respectively during the surgical treatment according to product instructions. Surgeons who would participate in the trial and use the study device should have completed at least 80 PCI procedures and need to be trained and supervised by the physician who completed the animal experiments using the investigational device.
General procedure of a surgical operation
Connect the power cord to the mains.
- Connect the power cord to the mains.
- Load the instruction unit, ensuring that the positioning mark on the base and that on the radiation-proof screen overlap.
- Switch on the system
- Activate the system.
- Prepare R-One consumables kit.
- Install the instruction unit protective sleeve.
- Install the cartridge.
- Install the robot.
- Attach the Y-connector clip to the cartridge.
- Insert the guide wire in the cartridge.
- Navigate the guide wire through the instruction unit
- Move the control lever and actuate the guidewire
- Fix the guidewire
- Insert the catheter into the cartridge
- Navigate the catheter through the instruction unit
- Move the control lever and actuate the catheter
- Securing catheter
- Simultaneous navigate the guidewire and catheter from the instruction unit
- Place the guide wire in the alternate path as a backup
- Place the catheter in the alternate path as a backup
- Adjust the robot position
- Primary Evaluation Indicators
- 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: Clinical surgical success Definition of clinical surgical success: 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 thrombolysis in myocardial infarction (TIMI) grade of 3. No major adverse cardiovascular events (MACE) occurred in the hospital.
- 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:
Technical success of the surgery
Definition of technical success:
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.
- Secondary Evaluation Indicators
- Procedure duration Calculation formula: Procedure duration = arterial sheath removal time - arterial sheath insertion time.
- Duration of robot-assisted treatment Calculation formula: Robot-assisted treatment duration = time when the robot finish moving the guidewire away from the coronary vessel - time when the robot starts manipulating the guidewire.
- Radiation exposure to the patient Evaluation Method: Measure and record dose exposure by angiography (DSA)
- Radiation exposure to surgeons Evaluation Method: Detect radiation through radiation dosimeters. Two dosimeters will be used simultaneously during the procedure. One is placed on the operating table and the other is worn by the surgeon to measure the radiation dose exposed to the surgeon. Both dosimeters will be calibrated once a day before use and reset to zero before each PCI procedure. Radiation readings from the dosimeter will be recorded when the first guidewire is inserted into the vessel and the last guidewire is pulled out of the vessel.
- Contrast dose Evaluation Method: Record the contrast dose used during intra-operative angiography
- MACE Evaluation Method: Record the MACE in-hospital and within 1 month (30±7 days) after the PCI procedure
- Product performance indicators Evaluation of intraoperative physiological load of surgeons. Evaluation Method: Surgeons are required to complete the Local Experienced Discomfort Questionnaire (LED scale) in time after the surgery in order to provide a retrospective evaluation of the physiological sensations during the procedure in the way of visual analog scale.
- Intraoperative psychological load evaluation of surgeons Evaluation Method: Surgeons are required to complete the Subjective Mental Effort Questionnaire (SME scale) in time after the surgery in order to provide a retrospective evaluation of the mental feelings during the procedure in the way of visual analog scale.
- Intraoperative remote control performance evaluation of surgeons Evaluation Method: Both remote and local surgeons are required to promptly complete postoperative subjective assessments of intraoperative operational experience, including real-time responsiveness of remote surgical maneuvers, image quality of remote high-definition DSA (Digital Subtraction Angiography) imaging, transmission immediacy of remote DSA images, immediacy and stability of remote audio transmission, and operational flexibility of the slave-side bedside manipulator arms.
- Incidence rate of serious system malfunction Calculation formula: Incidence rate of serious system malfunction = Number of procedures with serious system malfunction during robot-assisted surgery ÷ Number of procedures in which robot-assisted surgery was performed × 100%. Definition of serious system malfunction Evaluation Method: System malfunctions that occur during robot-assisted surgery that are difficult to repair in a short period of time and can have a serious impact on the surgical process or options.
- The occurrences of repairable system malfunction Evaluation Method: Definition of repairable system malfunction: Simple malfunctions that occur during robot-assisted surgery that can be repaired by a technician or the surgical team and do not have a serious impact on the surgical process or options.
- Evaluation of Device Usability Evaluation Method: Record the performance of the investigational device from preoperative preparation to the end of the procedure. Investigators are required to complete the Device Performance Evaluation Form after surgery and provide a retrospectively evaluation of performance of the investigational device during the trial.
- Indicators for Safety Evaluation Subjects' laboratory test results collected during the screening period, operation day, pre-discharge and 1-month post-operative visit, and information of adverse events during the clinical trial, as well as investigational device-related adverse events and serious adverse events.
- Being tested
- R-One assisted tele-PCI, R-One assisted on-site PCI
- Keywords
- PCI, tele-PCI, CAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-One assisted tele-PCIDevice
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 on-site PCIDevice
Surgeons perform operations by controlling robot from local console .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: R-One assisted on-site PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Operation day
Secondary outcomes (6)
Procedure duration
Procedure duration = arterial sheath removal time - arterial sheath insertion time
Measured: Operation day
Duration of robot-assisted treatment
Robot-assisted treatment duration = time when the robot finish moving the guidewire away from the coronary vessel - time when the robot start to move the guidewire away from the guiding catheter
Measured: Operation day
Radiation exposure to the patient
Evaluation Method: Measure and record dose exposure by angiography (DSA)
Measured: Operation day
Radiation exposure to surgeons
Detect radiation through radiation dosimeters. Two dosimeters will be used simultaneously during the procedure. One is placed on the operating table and the other is worn by the surgeon to measure the radiation dose exposed to the surgeon. Both dosimeters will be calibrated once a day before use and reset to zero before each PCI procedure. Radiation readings from the dosimeter will be recorded when the first guidewire is inserted into the vessel and the last guidewire is pulled out of the vessel.
Measured: Operation day
Contrast dose
Record the contrast dose used during intra-operative angiography
Measured: Operation day
MACE
Record the in-hospital MACE of subjects Record the MACE occurred 1 month (30±7 days) after the PCI procedure
Measured: Operation day and 1 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start14 Mar 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cathbot (Shanghai) Robot Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People's Hospital of Xinjiang Uygur Autonomous Region, Karamay Central Hospital of Xinjiang, The First Hospital of Kashgar Prefecture, Jimusar People's Hospital, Luopu People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yining Yang, Principal investigator, People's Hospital of Xinjiang Uygur Autonomous Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132255
- Sponsor's protocol ID
- R-One-20241121231
- Other IDs
- 20241121231
- Acronym
- tele-PCI
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platform Construction and Clinical Application of 5G Technology for Remote Operation of the R-One™ Robot in Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07132255
- Acronym / sponsor ID
- tele-PCI / R-One-20241121231
- Keywords
- PCI, tele-PCI, CAD
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cathbot (Shanghai) Robot Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- People's Hospital of Xinjiang Uygur Autonomous Region, Karamay Central Hospital of Xinjiang, The First Hospital of Kashgar Prefecture, Jimusar People's Hospital, Luopu People's Hospital
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Purpose To evaluate the effectiveness and safety of 5G-enabled remote control of the R-OneTM vascular interventional navigation control system for percutaneous coronary interventions.
- Research design A prospective, multicenter, exploratory clinical trial. Subjects who met the inclusion criteria and did not meet the exclusion criteria were enrolled into the clinical study, and the subjects are randomly grouped by using the interactive web response system (IWRS) applet (MedLand Centralized Randomization Management System). The surgeons completed the robotic-assisted surgical operation using the investigational device during cardiovascular PCI treatment. The investigator is also required to evaluate the performance of the investigational device during the procedure and ultimately determine the safety and efficacy of its clinical application.
- Device 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.
- Scope of Trial The subjects scope of the clinical trial: Patients requiring cardiovascular PCI.
- Experimental Procedure Information of all the patients who have signed the Informed Consent Form and actually pass the screening will be registered in the screening/enrollment log sheet. If a subject is excluded from the trial, the investigator should specify the reasons for screening failure. If a subject is enrolled in the trial but does not use the investigational device, the reason should also be recorded.
All subjects enrolled in the trial will be given a corresponding enrollment number.
72-hour pre-operative collected ECG, cardiac enzyme, and concomitant medication records.
Operation day visit The investigator is also required to complete the cardiology robot-assisted surgical treatment using the investigational device and record the procedure, LED Scale, SME Scale, and device Performance Evaluation Pre-discharge visit The investigator shall collect the blood test, creatinine, ECG. cardiac enzyme, concomitant medication records.
1 month post-operative visit The investigator shall collect the concomitant medication records.
Application method of the investigational device Subjects who meet the inclusion criteria and do not meet the exclusion criteria will be enrolled in the clinical study and the surgeon will complete the therapeutic treatment on the subject while performing the cardiology PCI procedure.
The investigational devices should be used by investigators respectively during the surgical treatment according to product instructions. Surgeons who would participate in the trial and use the study device should have completed at least 80 PCI procedures and need to be trained and supervised by the physician who completed the animal experiments using the investigational device.
General procedure of a surgical operation
Connect the power cord to the mains.
- Connect the power cord to the mains.
- Load the instruction unit, ensuring that the positioning mark on the base and that on the radiation-proof screen overlap.
- Switch on the system
- Activate the system.
- Prepare R-One consumables kit.
- Install the instruction unit protective sleeve.
- Install the cartridge.
- Install the robot.
- Attach the Y-connector clip to the cartridge.
- Insert the guide wire in the cartridge.
- Navigate the guide wire through the instruction unit
- Move the control lever and actuate the guidewire
- Fix the guidewire
- Insert the catheter into the cartridge
- Navigate the catheter through the instruction unit
- Move the control lever and actuate the catheter
- Securing catheter
- Simultaneous navigate the guidewire and catheter from the instruction unit
- Place the guide wire in the alternate path as a backup
- Place the catheter in the alternate path as a backup
- Adjust the robot position
- Primary Evaluation Indicators
- 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: Clinical surgical success Definition of clinical surgical success: 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 thrombolysis in myocardial infarction (TIMI) grade of 3. No major adverse cardiovascular events (MACE) occurred in the hospital.
- 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:
Technical success of the surgery
Definition of technical success:
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.
- Secondary Evaluation Indicators
- Procedure duration Calculation formula: Procedure duration = arterial sheath removal time - arterial sheath insertion time.
- Duration of robot-assisted treatment Calculation formula: Robot-assisted treatment duration = time when the robot finish moving the guidewire away from the coronary vessel - time when the robot starts manipulating the guidewire.
- Radiation exposure to the patient Evaluation Method: Measure and record dose exposure by angiography (DSA)
- Radiation exposure to surgeons Evaluation Method: Detect radiation through radiation dosimeters. Two dosimeters will be used simultaneously during the procedure. One is placed on the operating table and the other is worn by the surgeon to measure the radiation dose exposed to the surgeon. Both dosimeters will be calibrated once a day before use and reset to zero before each PCI procedure. Radiation readings from the dosimeter will be recorded when the first guidewire is inserted into the vessel and the last guidewire is pulled out of the vessel.
- Contrast dose Evaluation Method: Record the contrast dose used during intra-operative angiography
- MACE Evaluation Method: Record the MACE in-hospital and within 1 month (30±7 days) after the PCI procedure
- Product performance indicators Evaluation of intraoperative physiological load of surgeons. Evaluation Method: Surgeons are required to complete the Local Experienced Discomfort Questionnaire (LED scale) in time after the surgery in order to provide a retrospective evaluation of the physiological sensations during the procedure in the way of visual analog scale.
- Intraoperative psychological load evaluation of surgeons Evaluation Method: Surgeons are required to complete the Subjective Mental Effort Questionnaire (SME scale) in time after the surgery in order to provide a retrospective evaluation of the mental feelings during the procedure in the way of visual analog scale.
- Intraoperative remote control performance evaluation of surgeons Evaluation Method: Both remote and local surgeons are required to promptly complete postoperative subjective assessments of intraoperative operational experience, including real-time responsiveness of remote surgical maneuvers, image quality of remote high-definition DSA (Digital Subtraction Angiography) imaging, transmission immediacy of remote DSA images, immediacy and stability of remote audio transmission, and operational flexibility of the slave-side bedside manipulator arms.
- Incidence rate of serious system malfunction Calculation formula: Incidence rate of serious system malfunction = Number of procedures with serious system malfunction during robot-assisted surgery ÷ Number of procedures in which robot-assisted surgery was performed × 100%. Definition of serious system malfunction Evaluation Method: System malfunctions that occur during robot-assisted surgery that are difficult to repair in a short period of time and can have a serious impact on the surgical process or options.
- The occurrences of repairable system malfunction Evaluation Method: Definition of repairable system malfunction: Simple malfunctions that occur during robot-assisted surgery that can be repaired by a technician or the surgical team and do not have a serious impact on the surgical process or options.
- Evaluation of Device Usability Evaluation Method: Record the performance of the investigational device from preoperative preparation to the end of the procedure. Investigators are required to complete the Device Performance Evaluation Form after surgery and provide a retrospectively evaluation of performance of the investigational device during the trial.
- Indicators for Safety Evaluation Subjects' laboratory test results collected during the screening period, operation day, pre-discharge and 1-month post-operative visit, and information of adverse events during the clinical trial, as well as investigational device-related adverse events and serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| R-One assisted tele-PCI | Experimental | Device: R-One assisted tele-PCIThe 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. |
| R-One assisted on-site PCI | Active comparator | Device: R-One assisted on-site PCIThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-One assisted tele-PCISurgeons 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 tele-PCI |
| R-One assisted on-site PCISurgeons perform operations by controlling robot from local console . | Device | R-One assisted on-site PCI |
Primary outcome
Clinical success rate of the surgery
Time frame: Operation day
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.
Success rate of surgical techniques
Time frame: Operation day
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
6 secondary outcomes
Procedure duration
Time frame: Operation day
Duration of robot-assisted treatment
Time frame: Operation day
Radiation exposure to the patient
Time frame: Operation day
Radiation exposure to surgeons
Time frame: Operation day
Contrast dose
Time frame: Operation day
MACE
Time frame: Operation day and 1 month post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yining Yang principal investigator
People's Hospital of Xinjiang Uygur Autonomous Region
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R-One assisted tele-PCI and R-One assisted on-site PCI in people with Coronary Artery Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by Cathbot (Shanghai) Robot Co., Ltd at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate of the surgery (time frame: Operation day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.