Cardiovascular DiseasesNCT07135557
R-ONE® Robotically-Enhanced PCI Intervention Study
A study of Cardiovascular Diseases, run by Cathbot (Shanghai) Robot Co., Ltd at 4 sites in China.
Trial summary
The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic assisted percutaneous coronary intervention. This was a prospective, single-arm, multicenter, open-label, nonrandomized study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 4 sitesChina
- Study dates
- 23 Nov 2021to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- General Inclusion Criteria
- Subjects must meet all of the following inclusion criteria:
- 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.
- Angiography Inclusion Criteria
Show all 10Show fewer
- 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
- General Exclusion Criteria
- Subjects cannot meet any of the following exclusion criteria:
- 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);
Show all 26Show fewer
- 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.
- Angiography Exclusion Criteria
- 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.
- 2 or more lesions in a single vessel that need treatment concurrently;
- Bifurcation lesions requiring protection;
- Visible thrombosis;
- Target lesion located in the left coronary artery trunk;
- Target lesion within 5 mm of left anterior descending (LAD), left circumflex (LCX) or right coronary artery (RCA) opening;
- Severe distorted and/or calcified lesions, and its coronary anatomy is not applicable for robot-assisted PCI according to the the investigator.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Meizhou People's Hospital
Meizhou, Guangdong, 514031
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001
About this study
Official title: Evaluation of the Safety and Effectiveness of the R-One System in Percutaneous Coronary Interventions (PCI)
The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic assisted percutaneous coronary intervention. This was a prospective, single-arm, multicenter, open-label, nonrandomized study. The study protocol was approved by the institutional review boards or local ethics committees of the participating facilities, and all patients provided written informed consent.
Patients with angiographic documentation of obstructive coronary artery disease and evidence of myocardial ischemia were enrolled in the study. Major inclusion criteria were stenosis of target vessel at least 50% by visual estimate, with maximal length of 34 mm and maximal diameter of 4.0 mm, that could be completely covered by a single stent. Major exclusion criteria included planned PCI or coronary artery bypass graft surgery, required treatment of more than 2 coronary artery or more than 1 lesion in each target artery, previous stent implantation within 5.0 mm of the target lesion, target lesion within 5 mm of the artery opening, planned treatment with directional or rotational atherectomy, intraluminal thrombus, severe tortuosity or calcification of the lesion or proximal to it, involvement of a bifurcation, or unprotected left main coronary artery.
Read more
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. The robotic-assisted system is compatible with all commercially available 0.014-inch guidewires, rapid-exchange coronary angioplasty balloons, and stent delivery systems. Fluoro-scopic, electrocardiographic, and hemodynamic images are "slaved" to the duplicate monitors inside the cockpit, enabling visualization from a closer distance. All operators had training on the system that included either animal laboratory experience or using the device to simulate operation before enrolling patients in the study.
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 to perform pre-dilation, stent implantation, post-dilation, or drug balloon. 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. Clinical procedural success was defined as <30% residual stenosis and Thrombolysis In Myocardial Infarction (TIMI) grade 3 at the completion of the procedure of robotically-treated lesions as determined by a quantitative coronary angiographic core laboratory, in the absence of major adverse cardiovascular events (MACE), either before hospital discharge or within 30 days of the procedure, whichever occurred first. Major adverse cardiovascular events were defined as cardiac death, Q-wave or non-Q-wave myocardial infarction, or clinically driven target vessel revascularization. All events were adjudicated by an independent clinical events committee. Device technical success was defined as the successful intracoronary advancement and retraction of the PCI devices (guidewire, balloon and stent) by the robotic system, without conversion to manual operation.
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 of the R-OneTM vascular interventional navigation control system for percutaneous coronary interventions.
To evaluate the safety of the R-OneTM vascular interventional navigation control system for percutaneous coronary interventions.
Research design A prospective, multicenter, single-arm clinical trial. Subjects who met the inclusion criteria and did not meet the exclusion criteria were enrolled into the clinical study. The interventional cardiologists 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 mobile radiation-proof screen, and a consumable set (cartridge, instruction unit protective sleeve).
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.
Introductory study population: The first 2 subjects enrolled at each clinical research center are considered to be the introductory study population. The introductory study population comply with the same protocol as the primary study population in follow-ups, but their results were analyzed separately and not included in the primary study population analysis Screening visit (baseline data collection) To collect the basic clinical information or complete relevant assessment in order to confirm whether the subject could be enrolled in the trial.
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 interventional cardiologist 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 . Interventional cardiologists 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.
- 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
- Conditions
- Cardiovascular Diseases
- Being tested
- R-One vascular interventional navigation control system
- Keywords
- PCI, Robotic, Cardiovascular
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-One vascular interventional navigation control systemDevice
The interventional cardiologist sits at the cockpit and remotely performs the PCI using the console joysticks. The cassette, which is loaded with the interventional devices and connected to the guiding catheters, imposes axial and rotational forces on the intracoronary devices. Fluoroscopic, 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. Treatment was administrated according to local site protocols. Pre and post dilation was done per operator discretion. All intracoronary devices were to be manipulated exclusively by the robotic system, with bailout to manual conversion when needed.
| Study group | Role | What they receive |
|---|---|---|
| Evaluate safety and efficacy of the R-One vascular interventional navigation control system for PCI | Experimental | Not described Receives: Device: R-One vascular interventional navigation control system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate of the surgery
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: Day of surgery
Success rate of surgical techniques
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: Day of surgery
Secondary outcomes (6)
Procedure duration
Procedure duration = arterial sheath removal time - arterial sheath insertion time
Measured: Day of surgery
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: Day of surgery
Radiation exposure to the patient
Evaluation Method: Measure and record dose exposure by angiography (DSA)
Measured: Day of surgery
Radiation exposure to interventional cardiologists
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 interventional cardiologist to measure the radiation dose exposed to the interventional cardiologist. 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: Day of surgery
Contrast dose
Record the contrast dose used during intra-operative angiography
Measured: Day of surgery
MACE
Record the in-hospital MACE of subjects Record the MACE occurred 1 month (30±7 days) after the PCI procedure
Measured: Day of surgery 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 posted22 Aug 2025
- Study start23 Nov 2021
- Primary completion26 May 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The investigational device was R-One Vascular Interventional Navigation Control System and composed of following: The instruction unit is the control center and consists of a standby button, activation button, screen, acceleration button, stent/balloon catheter lever, guidewire lever, emergency stop button, guide rail, brake, and start/shutdown button. The robot consists of a table/support joint arm interface, table tilt button, fixture guide button, emergency stop button, release support arm brake button, and handles. The support joint arm consists of a support plate, a clamping clamp, a communication cable, a connector, and a support joint arm/table interface. The instruction unit protective sleeve consists of the operative field, the lever sleeve, and the shaper. The cartridge consists of cover, clamp backup, alternate path, guide path, wire guide slot, opening instruction of the rollers, and Y-connector clip.
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathbot (Shanghai) Robot Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese PLA General Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Shanxi Cardiovascular Hospital, Meizhou People's Hospital, Peking University
- Responsible party
- Sponsor
- Investigators
- Yundai Chen, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135557
- Sponsor's protocol ID
- CATHBOT-2021-R-One
- Status last verified
- Aug 2025
- First submitted
- 15 Nov 2022
- Last updated
- 22 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of the R-One System in Percutaneous Coronary Interventions (PCI)
- ClinicalTrials.gov ID
- NCT07135557
- Acronym / sponsor ID
- CATHBOT-2021-R-One
- Conditions
- Cardiovascular Diseases
- Keywords
- PCI, Robotic, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Cathbot (Shanghai) Robot Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Chinese PLA General Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Shanxi Cardiovascular Hospital, Meizhou People's Hospital, Peking University
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 22 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.
The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic assisted percutaneous coronary intervention. This was a prospective, single-arm, multicenter, open-label, nonrandomized study. The study protocol was approved by the institutional review boards or local ethics committees of the participating facilities, and all patients provided written informed consent.
Patients with angiographic documentation of obstructive coronary artery disease and evidence of myocardial ischemia were enrolled in the study. Major inclusion criteria were stenosis of target vessel at least 50% by visual estimate, with maximal length of 34 mm and maximal diameter of 4.0 mm, that could be completely covered by a single stent. Major exclusion criteria included planned PCI or coronary artery bypass graft surgery, required treatment of more than 2 coronary artery or more than 1 lesion in each target artery, previous stent implantation within 5.0 mm of the target lesion, target lesion within 5 mm of the artery opening, planned treatment with directional or rotational atherectomy, intraluminal thrombus, severe tortuosity or calcification of the lesion or proximal to it, involvement of a bifurcation, or unprotected left main coronary artery.
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. The robotic-assisted system is compatible with all commercially available 0.014-inch guidewires, rapid-exchange coronary angioplasty balloons, and stent delivery systems. Fluoro-scopic, electrocardiographic, and hemodynamic images are "slaved" to the duplicate monitors inside the cockpit, enabling visualization from a closer distance. All operators had training on the system that included either animal laboratory experience or using the device to simulate operation before enrolling patients in the study.
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 to perform pre-dilation, stent implantation, post-dilation, or drug balloon. 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. Clinical procedural success was defined as <30% residual stenosis and Thrombolysis In Myocardial Infarction (TIMI) grade 3 at the completion of the procedure of robotically-treated lesions as determined by a quantitative coronary angiographic core laboratory, in the absence of major adverse cardiovascular events (MACE), either before hospital discharge or within 30 days of the procedure, whichever occurred first. Major adverse cardiovascular events were defined as cardiac death, Q-wave or non-Q-wave myocardial infarction, or clinically driven target vessel revascularization. All events were adjudicated by an independent clinical events committee. Device technical success was defined as the successful intracoronary advancement and retraction of the PCI devices (guidewire, balloon and stent) by the robotic system, without conversion to manual operation.
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 of the R-OneTM vascular interventional navigation control system for percutaneous coronary interventions.
To evaluate the safety of the R-OneTM vascular interventional navigation control system for percutaneous coronary interventions.
Research design A prospective, multicenter, single-arm clinical trial. Subjects who met the inclusion criteria and did not meet the exclusion criteria were enrolled into the clinical study. The interventional cardiologists 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 mobile radiation-proof screen, and a consumable set (cartridge, instruction unit protective sleeve).
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.
Introductory study population: The first 2 subjects enrolled at each clinical research center are considered to be the introductory study population. The introductory study population comply with the same protocol as the primary study population in follow-ups, but their results were analyzed separately and not included in the primary study population analysis Screening visit (baseline data collection) To collect the basic clinical information or complete relevant assessment in order to confirm whether the subject could be enrolled in the trial.
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 interventional cardiologist 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 . Interventional cardiologists 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigational device was R-One Vascular Interventional Navigation Control System and composed of following: The instruction unit is the control center and consists of a standby button, activation button, screen, acceleration button, stent/balloon catheter lever, guidewire lever, emergency stop button, guide rail, brake, and start/shutdown button. The robot consists of a table/support joint arm interface, table tilt button, fixture guide button, emergency stop button, release support arm brake button, and handles. The support joint arm consists of a support plate, a clamping clamp, a communication cable, a connector, and a support joint arm/table interface. The instruction unit protective sleeve consists of the operative field, the lever sleeve, and the shaper. The cartridge consists of cover, clamp backup, alternate path, guide path, wire guide slot, opening instruction of the rollers, and Y-connector clip.
| Arm | Type | Receives |
|---|---|---|
| Evaluate safety and efficacy of the R-One vascular interventional navigation control system for PCI | Experimental | Device: R-One vascular interventional navigation control system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- General Inclusion Criteria
- 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.
- Angiography Inclusion Criteria
Key exclusion criteria (26 listed)
- General Exclusion Criteria
- 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);
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 vascular interventional navigation control systemThe interventional cardiologist sits at the cockpit and remotely performs the PCI using the console joysticks. The cassette, which is loaded with the interventional devices and connected to the guiding catheters, imposes axial and rotational forces on the intracoronary devices. Fluoroscopic, 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. Treatment was administrated according to local site protocols. Pre and post dilation was done per operator discretion. All intracoronary devices were to be manipulated exclusively by the robotic system, with bailout to manual conversion when needed. | Device | Evaluate safety and efficacy of the R-One vascular interventional navigation control system for PCI |
Primary outcome
Clinical success rate of the surgery
Time frame: Day of surgery
Clinical success rate = number of subjects that were clinical successes ÷ number of subjects that received surgical treatment × 100%. Evaluation Method: 1. 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. 2. No major adverse cardiovascular events (MACE) occurred in the hospital.
Success rate of surgical techniques
Time frame: Day of surgery
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. 1. 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 2. 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 3. 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: Day of surgery
Duration of robot-assisted treatment
Time frame: Day of surgery
Radiation exposure to the patient
Time frame: Day of surgery
Radiation exposure to interventional cardiologists
Time frame: Day of surgery
Contrast dose
Time frame: Day of surgery
MACE
Time frame: Day of surgery and 1 month post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Diabetes Mellitus, Type 2, Hypertension
RecruitingObservational study
Healthy Living BEYOND Weight Study
Overweight or Obesity
Not yet recruiting
ALDH2 Genetic Testing in East Asian Community
Healthy Adult, Flushing
Not yet recruitingEarly Phase 1
Multi-organ Imaging of Microvascular and Metabolic Function
Healthy Subjects (HS), Cardiovascular Diseases (CVD)
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. This study is not recruiting at the moment.
Yundai Chen principal investigator
Chinese PLA General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiovascular Diseases, run by Cathbot (Shanghai) Robot Co., Ltd at 4 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 10 inclusion and 26 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: finished, as of the sponsor's last update on 22 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 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Day of surgery). 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 22 Aug 2025; AzTrials last refreshed its copy on 29 Oct 2026.