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

• 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.

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.
• 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.

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