Platform Construction and Clinical Application of 5G Technology for Remote Operation of the R-One™ Robot in Percutaneous Coronary Intervention
Phase: NA
Conditions: Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Sponsor: Cathbot (Shanghai) Robot Co., Ltd

Protocol No.: R-One-20241121231
Platform Construction and Clinical Application of 5G Technology for
Remote Operation of the R-One™Robot in Percutaneous Coronary
Intervention
Clinical Trial Protocol
Version No.
: 1.0
Date
: 2025-03-01
Name of investigated device : Vascular Interventional Navigation Control System
Model/Specification : R-One
Class III devices subject to clinical trial:
Yes 
No 
Equivalent products in China
:
Yes 
No 
Leading institute
: People's
Hospital
of
Xinjiang
Uygur
Autonomous
Coordinating
Investigator
: Yang Yining
Sponsor
: Cathbot (Shanghai) Robot Co., Ltd.
CONFIDENTIALITY STATEMENT
All information contained in this program is owned by the sponsor. This document is only
available for revision by relevant healthcare institutions such as the investigator, study
participants, the ethics committee and the competent authorities. Without the written approval
of the sponsor, no information shall be disclosed to any third party irrelevant to this study
except for the necessary explanations made to subjects who may participate in this study
when they sign the informed consent.

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
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Version No.: 1.0 / Version Date: 2025-03-01
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I
Protocol Revision History
Version
No.
Date of
Revision
Revision Description
1.0
2025-03-01
/

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
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II
Protocol Abstract
Trial Name
Evaluation of the effectiveness and safety of
robot-assisted percutaneous coronary interventions
in
cardiology
using
the
R-OneTM
vascular
interventional navigation control system
Protocol No.
CATHBOT-2021-R-One
Date of Revision
1.0 / 2025-03-01
Sponsor
Cathbot (Shanghai) Robot Co., Ltd.
Test device
Vascular Interventional Navigation Control System
Test purpose
Evaluation of the Safety and Efficacy of the R-OneTM Vascular
Interventional
Navigation
Control
System
for
Percutaneous
Coronary Intervention Procedures
Study design
Prospective, multicenter, single-arm clinical study
Applied
Scope
of
Product
Cardiology PCI procedures
Scope
of
Subjects
Population
Patients requiring cardiology percutaneous coronary intervention
Total
Number
of
Cases
Randomized Controlled, 60 cases
Duration
of
Research
October, 2024 – September, 2026 (including subject screening,
enrollment and completed pre-discharge follow-up)
Primary Evaluation
Indicators
1
Clinical success rate of the surgery
1.1 Calculation formula:
Clinical success rate = number of subjects that were clinical
successes ÷ number of subjects that received surgical treatment ×
100%.
1.2 Definition of clinical success:

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
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III
(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.
2
Success rate of surgical techniques
2.1 Calculation formula:
Technical success rate = number of subjects that were technical
successes ÷ number of subjects received surgical treatment × 100%
2.2 Definition of technical success:
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; number of system restart
failure during robotic surgery <3.

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IV
Surgical
clinical
success
1.
Procedure duration (from arterial sheath insertion to
removal)
2.
Duration
of
robot-assisted
treatment
(from
robotic
guidewire manipulation initiation to withdrawal from
coronary vessel)
3.
Radiation exposure to the patient
4.
Radiation exposure to surgeons
5.
Contrast dose (mL)
6.
Cardiovascular disease-related deaths, perioperative and
spontaneous
myocardial
infarction
and
target
lesion
revascularization driven by clinical symptoms
- In-Hospital MACE
- 30-day MACE after PCI (30±7 days)
Performance
evaluation
indicators
1.
Evaluation
of
intraoperative
operation,
interface
friendliness, and smoothness of operation by surgeons
2.
Incidence rate of serious system malfunction
3.
The occurrences of repairable system malfunction
4.
Evaluation of Device Usability
Indicators
for
Safety Evaluation
Adverse events, adverse device effects and serious adverse events

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
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V
Glossary of terminologies and related abbreviations
ADE
Adverse Device Effect
AE
Adverse Event
ASADE
Anticipated Serious Adverse Device Effect
BARC
Bleeding Academic Research Consortium
CA
Competent Authority
CABG
Coronary Artery Bypass Grafting
CAD
Coronary Artery Disease
CEC
Clinical Events Committee
CERC
Cardiovascular European Research Center
CK
Creattinine Kinase
DS
Diameter Stenosis
cTn
Cardiac Troponin
EC
Ethics Committee
ECG
Electrocardiogram
eCRF
Electronic Case Report Form
GCP
Good Clinical Practices
ITT
Intention To Treat
LAD
Left Anterior Descending
LCX
Left Circumflex
LBBB
Left Bundle Branch Block
MI
Myocardial Infarction
NHLBI
National Heart, Lung, and Blood Institute
PCI
Percutaneous Coronary Intervention
PTCA
Percutaneous Transluminal Coronary Angioplasty

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
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VI
RCA
Right Coronary Artery
RVD
Reference Vessel Diameter
SADE
Serious Adverse Device Effect
SAE
Serious Adverse Event
SC
Steering Committee
SCAI
Society for Cardiac Angiograph and
Intervention
SOP
Standard Operating Procedure
ST
Stent Thrombosis
STEMI
ST-Elevation Myocardial Infarction
TC
Teleconference
TIMI
Thrombolysis In Myocardial Infarction
TL
Target Lesion
TLF
Target Lesion Failure
TLR
Target Lesion Revascularization
TVR
Target Vessel Revascularization
TV
Target Vessel
ULN
Upper Limit of Normal
USADE
Unanticipated Serious Adverse Device Effect
DCF
Data Clarification Form
SDV
Source Data Verification
CI
Confidence Interval
FAS
Full Analysis Set
PPS
Per Protocol Set
SS
Safety Set

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
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VII
HIS
Hospital Information System
NMPA
National Medical Products Administration
NYHA
New York Heart Association

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
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VIII
Assessed Items and Follow-Up Schedule
Visiting nodes
V1
V2
V3
V4
V5
Time window
-15 days
～Day 0
-72 hrs.
～Day 0
Day 0
Pre-
discharge
30 days
±7 days
Investigation phase
Assessed item
Screening visits
Operation
Day
Visit
Pre-
discharge
Visit
1 month
post-
operative
visit
Sign the informed
consent
×
General
Inclusion/Exclusion
Criteria
×
Inclusion/ exclusion
angiographic criteria
×
Demographic
Information
×
（1）
Pregnancy test (if
applicable)
×
（2）
Physical
examination
×
（3）
Blood routine test
×
（4）
×
Echocardiography
×
（5）
12-lead ECG.
×
（7）
×
Cardiac enzyme
markers
×
（8）
×
CREA
×
（6）
×
Angiography
×
Concomitant
×
×
×
×
×

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IX
medication records
Adverse events
record
×
×
×
×
×
Notes:
1.
Blood routine test includes: Red blood cells, white blood cells, hemoglobin and platelet
counts, etc.
2.
Concomitant medication records: is limited to records associated with adverse events.
3.
V5 1 month post-operative follow-up can be carried out by phone.
4.
Screening period examinations (1)-(6) accept examination results 15 days before the
surgery, (5) accepts examination results within 3 days after surgery, (7)-(8) accept
examination results 72 hours before the surgery, record as baseline data, and it's not
required that the time of examination should be after the signing the informed consent.
5.
Cardiac enzyme markers include: Creatine kinase (CK), creatine kinase isoenzyme
(CKMB), troponin T or I (TnT or Tnl). If 48h postoperative CK-MB > 5 times above the
upper limit of normal range or troponin > 35 times above the upper limit of normal range,
the investigator should decide whether the subject need re-examination based on his
symptoms; otherwise, the 48h post-operative examination of cardiac enzyme marker can
be considered as the pre-discharge test and do not need other additional ones.

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
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X
Table of Contents
1
Sponsor Information............................................................................................................1
1.1 Name of sponsor.............................................................................................................1
1.2 Office Address................................................................................................................1
1.3 Name of participate sites................................................................................................ 1
1.4 Investigators information................................................................................................1
2
Background information of clinical trial.............................................................................3
2.1 Clinical Application Background...................................................................................3
2.2 CoA of investigational device........................................................................................ 6
2.3 Summary of Animal Experiments..................................................................................7
2.4 Summary of registered clinical trials..............................................................................8
3
Investigational device..........................................................................................................8
3.1 Test device......................................................................................................................8
3.2 Requirements for communication networks.................................................................15
3.3 Scope of Trial............................................................................................................... 17
4
The application, contraindications and precautions of the investigational device............17
4.1 Scope of application..................................................................................................... 17
4.2 Product Contraindications............................................................................................ 17
4.3 Precautions................................................................................................................... 17
4.4 Device Administration..................................................................................................18
5
Overall Design of the Clinical Trial..................................................................................19
5.1 Study Objective............................................................................................................ 19
5.2 Sample size...................................................................................................................19
5.3 Research design............................................................................................................19
5.4 Selection of investigational methods and rationale......................................................20
5.5 Subject Selection.......................................................................................................... 23
6
Primary Evaluation Indicators...........................................................................................25
6.1 Clinical success rate of the surgery.............................................................................. 25
6.2 Success rate of surgical techniques.............................................................................. 25
7
Secondary Evaluation Indicators.......................................................................................26
8
Product performance indicators........................................................................................ 27
9
Indicators for Safety Evaluation........................................................................................28
10 Experimental Procedure....................................................................................................29
11 Application method of the investigational device.............................................................29
12 General procedure of a surgical operation........................................................................ 30
13 Feasibility..........................................................................................................................31
13.1 Analysis of subject risks and the probability of trial failure.........................................31

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XI
13.2 Analysis of subject benefits and probability of trial success........................................31
14 Monitoring and Quality Control of Clinical Trial.............................................................33
15 Ethical protection and informed consent in clinical trial.................................................. 35
15.1 Ethical Considerations..................................................................................................35
15.2 Approval of Trial Protocol........................................................................................... 35
15.3 Informed consent process.............................................................................................35
15.4 Text of Informed Consent Form...................................................................................36
16 Regulations for Reporting Adverse Events and Device Defects.......................................37
16.1 adverse event................................................................................................................ 37
16.2 Serious adverse events..................................................................................................38
16.3 Anticipated Adverse Events......................................................................................... 39
16.4 Treatment of adverse events.........................................................................................40
17 Terms of trial.....................................................................................................................46
17.1 Principle of confidentiality...........................................................................................46
17.2 Agreement on publication of trial results..................................................................... 46
17.3 Insurance.......................................................................................................................47
18 Rights and responsibilities of the parties...........................................................................47
18.1 Subjects' rights..............................................................................................................47
18.2 Assume institutional and investigator responsibilities for clinical trials......................48
19 Appendices........................................................................................................................52
19.1 Local Discomfort Experience Scale............................................................................. 52
19.2 Subjective Mental Load Scale......................................................................................53
19.3 Device Performance Evaluation Form......................................................................... 54
19.4 System malfunction Record Form................................................................................56
19.5 NYHA Classification:.................................................................................................. 57
20 References.........................................................................................................................59

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1
Sponsor Information
1.1 Name of sponsor
People's Hospital of Xinjiang Uygur Autonomous Region
1.2 Office Address
91 Tianchi Road, Xinjiang Uygur Autonomous Region, China
1.3 Name of participate sites
Karamay Central Hospital
Luopu County People's Hospital
The First Hospital of Kashgar Prefecture
Jimusar County People's Hospital
1.4 Investigators information
Name
Clinical Title
Institution/Affiliation
Role
1
Yang Yining
Chief
Physician
People's Hospital of Xinjiang Uygur
Autonomous Region
Principal
Investigator
2
Yu Xiaolin
Chief
Physician
People's Hospital of Xinjiang Uygur
Autonomous Region
Project
Leader
3
Wang Zhao
Chief
Physician
People's Hospital of Xinjiang Uygur
Autonomous Region
Clinical
Investigator
4
Yuan Yujuan
Attending
Physician
People's Hospital of Xinjiang Uygur
Autonomous Region
Biostatiscian
5
Fan Hao
Attending
Physician
People's Hospital of Xinjiang Uygur
Autonomous Region
Clinical
Investigator

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
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6
Dong Xiangyu
Attending
Physician
People's Hospital of Xinjiang Uygur
Autonomous Region
Clinical
Investigator
7
Li Yan
Chief
Physician
Karamay Central Hospital
Site
Investigator
8
Keremujiang
Tuersunniyazi
Chief
Physician
Luopu County People's Hospital
Site
Investigator
9
Yang Heyin
Chief
Physician
The
First
Hospital
of
Kashgar
Prefecture
Site
Investigator
10
Shan Fuxiang
Chief
Physician
Jimusar County People's Hospital
Site
Investigator

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
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2 Background information of clinical trial
2.1Clinical Application Background
The prevalence of coronary heart disease (CHD) in China continues to rise, with 11.39 million
people suffering from CHD. Cardiovascular disease is the leading cause of death among
urban and rural residents in our country [1]. With the development of treatment technologies
and equipment, percutaneous coronary intervention (PCI) has become the main treatment
method for cardiovascular diseases. The number and complexity of PCI operations continue
to increase, further increasing the burden of surgeons [2]. A large number of studies have
proved that the cumulative radiation dose received by vascular interventional physicians
cannot be ignored. With a large number of surgeries, the cumulative radiation dose of
experienced interventional physicians is even greater [3]. Long-term low-dose radiation can
lead to lens opacity, a significant increase in the incidence of brain and left head tumors, and
thickening of the carotid intima associated with carotid artery stenosis [4,5]. Wearing heavy
lead clothing for a long time also causes nearly 50% of cardiac interventionist to report at
least one orthopedic disease [6]. Surveys show that over 84% of people believe that better
occupational protection will ultimately benefit patients [6]. Therefore, robot-assisted coronary
intervention surgery is one of the solutions to this inevitable trend.
Since the initial application in 2006, robot-assisted PCI has been shown to be safe and
feasible in simple lesions. With advances in system technology and increased operator
experience, vascular interventional robots are also beginning to be applied to complex, more
“real-world” lesions, where their safety and efficacy have been further validated
[7-13].
However, reducing radiation exposure for the operator is not the sole objective of vascular
interventional robotics. It is also envisioned that robotic surgery can assist in decision-making,
enhance the operator’s operations, further improve surgical safety and efficacy, achieve more
precise treatment targeting, reduce patients' radiation exposure and contrast dose, thereby
benefiting both patients and physicians. The R-One™vascular interventional robot employs
an innovative bionic twisting technology that replicates the hand movements of physicians.
Through mechanical clamping and millimeter-level stepping, it delivers superior motion
stability and high precision, preventing unintended displacement of instruments caused by

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operator muscle tremors, fatigue, or mishandling during instrument exchanges. Robotic-
assisted surgery eliminates the limitations of manual methods, such as tremors that may lead
to serious complications, thereby enhancing surgical precision and safety. Simultaneously, it
reduces the need for repeated manipulations and instrument repositioning, consequently
lowering
patients'
radiation
doses
and
contrast
agent
consumption
[Patent
No.:
CN107847281B;
CN106535808B].
Thanks
to
its
unique
technological
design,
the
introduction and removal of instruments (guidewires and balloon/stent catheters) takes only
one second. The R-One robotic platform can precisely and perfectly replicate hand
movements, ensuring medical staff can execute procedures rapidly. Owing to its intuitive
operation, the R-One platform features a swift learning curve. As early as the 2017 safety
study of this device, medical personnel—without any specialized training—demonstrated that
robotic-assisted PCI differed from manual PCI by merely one minute in procedure time. As
part of using R-One for coronary interventions, interventional cardiologists can operate the
robot via a console behind radiation-proof screens while seated almost entirely. This
significantly improves ergonomic positioning and comfort for healthcare providers. The setup
also enhances surgical visual feedback by enabling closer observation. The control station
features a mobile radiation shield (190 cm height × 152 cm width × 118 cm depth),
accommodating multiple personnel to ensure protection for the entire care team. The secure
execution of interventional procedures substantially reduces stress among medical staff.
Comprehensive protection against radiation exposure prevents occupational injuries, thereby
contributing to improved patient care quality.
The advancement and widespread adoption of internet technology have dismantled spatial
barriers in human interaction, enabling cross-regional communication and interaction. Since
the inception of internet technology, the medical field has endeavored to leverage it to
overcome temporal and spatial constraints. In September 2001, doctors from New York
carried out the world's first attempt at remote surgery for patients on the other side of the
Atlantic in Strasbourg[15]. The operation was performed using the Zeus robot, which
transmitted signals through dedicated submarine optical fibers to carry out a cholecystectomy
for the patient, leaving behind a surgical name named after the explorer who first crossed the
Atlantic Ocean - the Lindbergh operation. Since then, several clinical studies on remote

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surgery based on endoscopic surgical robot systems have explored the safety and efficacy of
remote robotic surgery [16-18].
With the development of vascular interventional surgery robot technology and 5G
telemedicine technology, cardiac interventional experts have begun to explore vascular
interventional robot-assisted PCI surgery based on 5G remote technology. In 2020, Professor
Ryan from the Frederik Meijer Heart & Vascular Institute performed PCI procedures on
vascular simulators, with 20 target lesions operated on and 16 target lesions consecutively
treated in the transcontinental model, in New York (206 miles, regional model) and San
Francisco (3,085 miles, transcontinental model) using a remote vascular interventional robotic
system (Corpath) console in Boston. System measurements revealed master-slave delays by
comparing transcontinental model with regional model as follows: 121.5 ± 2.4 ms vs. 67.8 ±
0.9 ms (p < 0.001) in the wired mode; 162.5 ± 1.1 ms vs. 86.6 ± 0.6 ms (p < 0.001) in the 5G
mode. Although statistically significant differences in delay existed between models,
operators rated the latency as "imperceptible" in both scenarios [19].
China's vast territory leads to uneven distribution of medical resources. High-quality doctors
and advanced equipment are predominantly concentrated in first-tier and provincial capital
cities, while remote grassroots areas suffer from underdevelopment and scarce medical
resources. This forces patients to travel long distances for treatment, increasing burdens on
both patients and hospitals. Cross-regional medical access has long been a challenge in
healthcare development. 5G communication technology, with its advantages of high
throughput, low latency, and massive connectivity, can empower China's medical services
toward mobility, remote operation, and intelligent development when integrated with robotics.
This integration enables the implementation of remote surgery. Therefore, the development of
5G remote surgical robot system and its regular application can enable surgeons to be free
from time and space restrictions, allowing patients to receive high-quality medical services
locally. This is conducive to the balanced development of high-quality medical resources and
truly makes high-quality medical services accessible to the general public.
The success of remote surgery hinges on, on the one hand, operational consistency and real-
time synchronization between the master and slave systems of surgical robots; on the other
hand, technical robustness, including signal stability, anti-interference capability, and high-

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throughput data transmission [18]. Network latency severely impacts surgical operations; data
transmission latency affects surgical operation time; latency fluctuation causes packet
disordering, leading to mechanical jitter in robotic manipulators.
The device tested in this study adds a remote communication workstation and a remote
control room (1 doctor console +1 remote communication workstation) on the previous
generation product. By taking advantage of the 5G communication technology's flexible
multi-point layout, large bandwidth, low latency and high reliability, the DSA images are
transmitted to the surgical experts to achieve remote control of the robot. At the same time,
through remote real-time audio and video communication, cardiac interventional surgery
experts can perform robot-assisted remote PCI for patients. R-OneTM vascular intervention
robot is embedded software with negligible end-to-end delay. After adding 5G remote robotic
surgery function, risks mainly come from 5G network transmission delay, packet loss and
network disconnection. The remote control module of R-OneTM vascular intervention robot
adopts end-to-end control, remotely transmitting control signals and emergency stop signals.
The operation mode of remote control remains unchanged, achieving continuous signal
transmission, which has good reliability and stability. If the network condition, delay and
packet loss are comprehensively evaluated before the operation and meet the clinical and
technical requirements, remote surgery can be carried out. All instructions are transmitted
continuously, and remote control handle instructions are updated in real time to ensure that
network delay and packet loss do not exceed clinical and technical requirements. In case of
abnormality, network interruption or emergency, it can switch local or local manual operation
with one key.
This clinical study used the "Vascular Interventional Navigation Control System" (i.e., the
experimental device) to complete the classic PCI surgery with the assistance of a remote robot,
and to evaluate the safety and efficacy of this system in the treatment of cardiology.
2.2CoA of investigational device
According to the requirements of Provisions on Medical Devices Registration Administration,
Norms on the Quality Management of Medical Devices for the Clinical Trials and other

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regulations issued by the National Medical Products Administration and relavant health
authorities, the product shall attained the CoA from medical device testing institutions that
meet the relevant qualifications before clinical trial for registration, and its performance shall
meet the safety standards of national, industry or relevant requirements.
2.3Summary of Animal Experiments
From October 2017 to May 2018, the sponsor initiated a series of animal experiments for the
Vascular Interventional Navigation Control System. The results confirmed the safety and
efficacy of the system for PCI procedures. A total of 14 procedures were carried out on 3-5
months old, 62-70 kg female Landrace pigs, including the representative cardiology surgical
option PCI. The experiment was designed to compare the R-One robotic approach (test group)
with the gold standard manual approach (control group) in terms of implantation and evaluate
the efficacy and safety with the same criteria. There were 7 procedures and 4 pigs in each
group (2 acute, 2 chronic). Pathological analysis was performed after 30 days of postoperative
followed up. 3 pigs died on the day of surgery.
All the implantation procedures went
smoothly, without any robot-related major adverse event. Efficacy was evaluated in all
arteries undergone implantation, and no safety issues were observed. All chronic animals
completed the 30-day follow-up smoothly and successfully. The stent patency achieved good
performance during implantation and completion, with no abnormalities at the implantation
position or on distal organs, indicating sound local and general tolerability. No significant
lesions were found at the histological level. Both implantation methods were a success and
had no difference based on the criteria of mobility, navigation, implantation accuracy, stent
function (TIMI score), and stent tissue integration.
Therefore, it can be confirmed that the efficacy of stent implantation through a robotic
approach is 100%. In term of safety, no significant adverse events had been reported through
either the manual or robotic approach.
The duration was approximately 1 minute longer, the
dose of contrast increased by approximately 9 ml, the total exposure to X-ray was
approximately 1 minute longer, and the cumulative X-ray dose of patient was approximately 3
mGy.cm2 higher in R-One robotic implantation.
It's possible that these results are correlated

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to the learning curve of robotic implantation and is believed to improve over time through
practice. The surgeons expressed that the R-One became easy and intuitive to use after a short
training period, improved surgical conditions by providing comfortable sitting position and X-
ray protection, and was qualified to proceed with clinical trials.
2.4Summary of registered clinical trials
In order to verify the safety and effectiveness of "R-One vascular interventional navigation
control system" for PCI surgery in cardiology department, from September 2021 to
September 2022, Zhimai (Shanghai) Robotics Co., Ltd. initiated a prospective, multi-center,
single-arm clinical trial. Four centers participated in the study, and a total of 145 subjects were
enrolled who required cardiac PCI. The average age of all subjects was 61.92 years old, male
69.66%, female 30.34%, and average body mass index (BMI) 25.01. Among 145 subjects, 6
(4.14%) had two target lesions. The mean diameter of the target vessel was 3.14 mm, and the
mean length of the target lesions was 20.07mm. Complex lesions (type B2 and C lesions)
accounted for 38.41%, and the preoperative stenosis degree of the target lesion was 88.28%.
The clinical success rate of the surgery and the success rate of surgical techniques were 100%.
There was no in-hospital major adverse cardiovascular events (MACE), and no MACE
occurred within 30 days after PCI. In the robot-assisted PCI operation stage, the radiation
dose of the operator was 97.59% lower than that of the traditional manual surgery bedside
operator. The performance evaluation of the device was good. No serious system failures
occurred in the four clinical trial centers during the enrollment period. There were no adverse
events related to the trial device and no device defects. This conclusion demonstrates the
safety, efficacy and reliability of this product in assisting the treatment of PCI surgery in
cardiology, meeting the clinical application requirements of PCI surgery in cardiology and
providing a reasonable basis for subsequent clinical application and promotion.
3
Investigational device
3.1Test 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

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a remote workstation.
General architecture of 5G-based remote vascular interventional robot-assisted PCI surgery
3.1.1
Instruction Unit
The instruction unit is the control center of the R-One Vascular Interventional Navigation
Control System and consists of a standby button, stent/balloon catheter lever activation button,
navigation guidewire activation button, screen, stent/balloon catheter acceleration button,
guidewire acceleration button, stent/balloon catheter lever, guidewire lever, emergency stop
button, guide rail, brake, and start/shutdown button.
Name of the components
Model & Specifications
Instruction Unit
Standby button
R-One
Stent/balloon catheter lever
activation button
Navigation guide wire
activation button
Screen
Stent/balloon catheter
acceleration button
Guidewire acceleration button
Stent/balloon catheter lever
Guidewire lever
Emergency stop button

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Guide
Brake
On/off button
Schematic diagram of instruction unit
3.1.2
Robot
Standby button
Screen
Navigation guide wire activation button
Stent/balloon catheter lever
activation button
Emergency stop button
Stent/balloon catheter
acceleration button
Stent/balloon catheter lever
Guidewire
acceleration button
Guidewire lever

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The robot consists of a table/support joint arm interface, table tilt button, fixture guide button,
LED indicator, emergency stop button, release support arm brake button, and handles.
Name of the components
Model & Specifications
Robot
Table/support joint arm
interface
R-One
Table tilt button
Fixture guide button
LED indicator
Emergency stop button
Release support arm brake
button
Handles
Robot schematic diagram
3.1.3
Support joint arm
The support joint arm consists of a support plate, a clamping clamp, a communication cable, a
LED indicator
Fixture guide button
Table tilt button
Release
support
arm
brake
button
Handles
Emergency stop button
Table/support joint arm interface

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connector, and a support joint arm/table interface.
Name of the components
Model & Specifications
Support joint arm
Supportive plate
R-One
Clamp
Communication Cable
Connectors
Clamp
Schematic diagram of the support joint arm
3.1.4
Instruction unit protective sleeve
The instruction unit protective sleeve consists of the operative field, the lever sleeve, and the
shaper.
Name of the components
Model & Specifications
Instruction unit
protective sleeve
Operative field
R-One
Control rod bushings
Shaper
Connectors
Communication Cable
Table/support joint arm interface
Supportive plate
Clamp

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Schematic diagram of the instruction unit protective sleeve
3.1.5
Cartridge
The cartridge consists of cover, clamp backup, alternate path, guide path, wire guide slot,
opening instruction of the rollers, and Y-connector clip.
Name of the components
Model & Specifications
Cartridge
Cover
R-One
Clamp backup
Alternate path
Catheter Path
Guide Path
Opening command of the
rollers
Y-connector clip
Operative field
Control rod bushings
Shaper

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Cartridge schematic diagram
3.1.6
Remote communication workstation
To achieve remote surgery, remote communication workstations need to be configured at all
locations where remote surgery is performed. The remote control module adopts end-to-end
control, remotely transmitting control signals and emergency stop signals. The operation
mode of remote control remains unchanged, achieving continuous signal transmission.
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. For the safety of remote surgery, invitation codes need to be obtained through offline
communication.
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
Cover
Clamp backup
Alternate path
Guide Path
Catheter Path
Opening command of the
rollers
Y-connector clip

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achieve remote control and data exchange.
The communication workstation includes an codec integrated machine to achieve video
encoding and decoding. The DSA video of the local operating room can be encoded and
transmitted over the network to the communication workstation of the remote control terminal.
After decoding, it can be output to the display of the remote doctor's console, so that the
remote doctor can receive visual feedback.
In addition, to eliminate the communication barriers for medical staff in different locations,
the remote communication workstation is equipped with a multi-source video conferencing
system, which enables barrier-free communication between different places. Meanwhile, this
conference system also supports third-party access, enabling remote technical support and
surgical guidance.
3.2 Requirements for communication networks
The remote surgery system does not limit the type of communication network, which can be
5G network, fiber optic line, wired or wireless LAN, or other better and safer networks, as
long as point-to-point communication (LAN or virtual LAN) can be realized between the two
places, and the network performance indicators meet the requirements of remote surgery.
3.2.1
Common network architectures
5G slice dedicated line network is currently the preferred communication network for ultra-
remote surgery due to its safe, efficient and reliable network environment. However, at the
same time, there is also the demand for remote surgery between multiple campuses in the
same hospital, which can be realized through LAN or virtual LAN between multiple
campuses for close-range remote surgeries.
3.2.2
Requirements for network performance
5G remote interventional surgery needs to transmit control and feedback signals between the
remote end and the local end, transmitting the patient's DSA image from the operating room
to the remote control end. It also needs to establish video conferencing systems in two places,
so there are certain requirements for network performance.
The maximum transmission rate of the control signal is 1312 bytes per frame, with a frame
rate of 4Khz and a theoretical rate of 40Mbps. The DSA signal and video conferencing use

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H264 compression, with an average DSA rate of 10Mbps and an average video conferencing
rate of 5Mbps.
In terms of delay, limited by the overall delay of 305ms, the network delay is limited to 55ms,
the control signal delay is limited to 135ms, and the remote delay of DSA image (including
image processing delay, codec delay and network delay) is limited to 170ms. The video
conference system has no impact on the overall operation delay, and the general video
conference delay requires 300ms.
Through the test, the 3D video transmission is unstable when the network packet loss rate is
≥0.5%. Therefore, 0.5% is set as the upper limit.
Remote surgical network communication topology based on 5G section dedicated line
Based on the above description, the system performance should comply with the provisions of
the following table:
Data type
Rate requirement
Delay requirement
Reliability
Control signals
Upload and download
speeds ≥40Mbps
≤135ms
≥99.999%
DSA images
Upload and download
speeds ≥10Mbps
≤170ms
≥99.999%

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Video conference
Upload and download
speeds ≥5Mbps
≤300ms
≥99.999%
Delay < 55ms; Jitter < 30ms; RTT delay range: 80-140ms; Bandwidth: 65Mbps
3.3Scope of Trial

The subjects scope of the clinical trial: Patients requiring cardiovascular PCI.
4
The application, contraindications and precautions of the
investigational device
4.1
Scope of application
Cardiovascular PCI.
4.2
Product Contraindications
Contraindications to the use of system have yet to been known. But it applies to the
contraindications of artificial coronary angioplasty treatment.
4.3
Precautions
4.3.1
The system should only be used by interventional cardiologists who have received
specific training for the use of the R-One device. Robocath only provides training
related to the use of the system and is not a substitute for the necessary expertise and
medical training for percutaneous coronary intervention (PCI).
4.3.2
The guidewire and/or stent/balloon catheter should not be moved through this system
without x-ray examination.
4.3.3
The navigation speed of the guidewire and/or stent/balloon catheter should adapt to
arterial area traversed. The rapid navigation mode can only be put into use when the
guidewire and/or stent/balloon catheter is located within the guiding catheter.
4.3.4
The R-One robot platform is dedicated for use in combination with mobile radiation-
proof screen and the R-One consumable kit.

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4.3.5
The R-One system is only compatible with the devices shown in the table below.
Device/Equipment
0.014 inch guide wire
Rapid exchange stent/balloon catheters
Y-connector:
- Super KetchTM of Minvasys
- Merit Medical's Honor ®Hemostasis Valve
4.4 Device Administration
4.4.1 Packaging label
All investigational devices are subject to strict self-inspection before they leave the factory.
The product label is printed with words of "for clinical trials" and the serial number of the
product, which can be used to trace the production and usage of the device.
4.4.2 Storage and transport conditions
4.4.2.1 Environmental Conditions for the R-One Robotic Platform
Transportation
-40℃-70℃
Not in wet place
Caution: System performance won't be guaranteed if conditions exceed specifications in this
section
4.4.2.2 Environmental conditions for the R-One consumable kit
Transportation
Storage
-30℃-50℃
Store in a cool, dry place, and avoid light and
direct sunlight
18℃-30℃
Store in a cool, dry place, and avoid light
and direct sunlight
In principle, the investigational device should be protected from heavy pressure, direct
sunlight and rain during transportation and be stored in a dry, cool, dust-proof room
(according to the product specification).
Ordinary operation such as cleaning, disinfection, sterilization, and maintenance of the

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devices should be carried out in accordance with the instructions for use and clinical
specifications.
The relevant investigational devices are intended for use in this clinical trial only and shall not
be used for other purposes.
4.4.3 Usage record
investigational devices must be managed by a person designated by the principal investigator,
and written records of the receipt, use, and retrieval of devices must be kept.
5
Overall Design of the Clinical Trial
5.1 Study Objective
The purpose of this study is to evaluate the effectiveness and safety of the R-OneTM vascular
interventional navigation control system for percutaneous coronary interventions.
5.2 Sample size
The sample size calculation was based on the primary endpoint, i.e., the surgical success
indicator. Based on the results of sample size calculation by PASS software, it was concluded
that when the significance level of the statistical test was taken as unilateral 2.5% and 63
subjects were enrolled, there would be more than 90% certainty to conclude that the 5G
telecontrol robot performs better PCI surgery.
5.3 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 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

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ultimately determine the safety and efficacy of its clinical application.
Data collected at the baseline and intra-operative angiography will be used as a basis for
determining whether subjects are applicable for enrollment and undergo surgical treatment.
5.4 Selection of investigational methods and rationale
5.4.1
Surgical options
This clinical trial plans to enroll subjects who need to undergo percutaneous coronary
intervention.
5.4.2
Endpoint selection
5.4.2.1
General Information of Vascular Interventional Robots
Since the initial application in 2006, robot-assisted PCI has been shown to be safe and
feasible in simple lesions. With advances in system technology and increased operator
experience, vascular interventional robots are also beginning to be applied to complex, more
“real-world” lesions, where their safety and efficacy have been further validated
[7-13].
However, reducing radiation exposure for the operator is not the sole objective of vascular
interventional robotics. It is also envisioned that robotic surgery can assist in decision-making,

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enhance the operator’s operations, further improve surgical safety and efficacy, achieve more
precise treatment targeting, reduce patients' radiation exposure and contrast dose, thereby
benefiting both patients and physicians. The R-One™vascular interventional robot employs
an innovative bionic twisting technology that replicates the hand movements of physicians.
Through mechanical clamping and millimeter-level stepping, it delivers superior motion
stability and high precision, preventing unintended displacement of instruments caused by
operator muscle tremors, fatigue, or mishandling during instrument exchanges. Robotic-
assisted surgery eliminates the limitations of manual methods, such as tremors that may lead
to serious complications, thereby enhancing surgical precision and safety. Simultaneously, it
reduces the need for repeated manipulations and instrument repositioning, consequently
lowering
patients'
radiation
doses
and
contrast
agent
consumption
[Patent
No.:
CN107847281B; CN106535808B].
Thanks to its unique technological design, the introduction and removal of instruments
(guidewires and balloon/stent catheters) takes only one second. The R-One robotic platform
can precisely and perfectly replicate hand movements, ensuring medical staff can execute
procedures rapidly. Owing to its intuitive operation, the R-One platform features a swift
learning curve. As early as the 2017 safety study of this device, medical personnel—without
any specialized training—demonstrated that robotic-assisted PCI differed from manual PCI
by merely one minute in procedure time. As part of using R-One for coronary interventions,
interventional cardiologists can operate the robot via a console behind radiation-proof screens
while seated almost entirely. This significantly improves ergonomic positioning and comfort
for healthcare providers. The setup also enhances surgical visual feedback by enabling closer
observation. The control station features a mobile radiation shield (190 cm height × 152 cm
width × 118 cm depth), accommodating multiple personnel to ensure protection for the entire
care team. The secure execution of interventional procedures substantially reduces stress
among medical staff. Comprehensive protection against radiation exposure prevents
occupational injuries, thereby contributing to improved patient care quality.
The advancement and widespread adoption of internet technology have dismantled spatial
barriers in human interaction, enabling cross-regional communication and interaction. Since
the inception of internet technology, the medical field has endeavored to leverage it to

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overcome temporal and spatial constraints. In 2020, Professor Ryan from the Frederik Meijer
Heart & Vascular Institute performed PCI procedures on vascular simulators, with 20 target
lesions operated on and 16 target lesions consecutively treated in the transcontinental model,
in New York (206 miles, regional model) and San Francisco (3,085 miles, transcontinental
model) using a remote vascular interventional robotic system (Corpath) console in Boston.
System measurements revealed master-slave delays by comparing transcontinental model
with regional model as follows: 121.5 ± 2.4 ms vs. 67.8 ± 0.9 ms (p < 0.001) in the wired
mode; 162.5 ± 1.1 ms vs. 86.6 ± 0.6 ms (p < 0.001) in the 5G mode. Although statistically
significant differences in delay existed between models, operators rated the latency as
"imperceptible" in both scenarios [19].
China's vast territory leads to uneven distribution of medical resources. High-quality doctors
and advanced equipment are predominantly concentrated in first-tier and provincial capital
cities, while remote grassroots areas suffer from underdevelopment and scarce medical
resources. This forces patients to travel long distances for treatment, increasing burdens on
both patients and hospitals. Cross-regional medical access has long been a challenge in
healthcare development. 5G communication technology, with its advantages of high
throughput, low latency, and massive connectivity, can empower China's medical services
toward mobility, remote operation, and intelligent development when integrated with robotics.
This integration enables the implementation of remote surgery.
The success of remote surgery hinges on, on the one hand, operational consistency and real-
time synchronization between the master and slave systems of surgical robots; on the other
hand, technical robustness, including signal stability, anti-interference capability, and high-
throughput data transmission [18]. Network latency severely impacts surgical operations; data
transmission latency affects surgical operation time; latency fluctuation causes packet
disordering, leading to mechanical jitter in robotic manipulators.
5.4.2.2
Primary endpoint
As with any medical devices, surgeons who use vascular interventional navigation control
systems are challenged with learning curves.
The primary endpoints of this clinical trial are "clinical success rate" and "technical success

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rate". Clinical success is defined as: 1. Target lesion was treated with the investigational
device, residual stenosis of the target vessel (visual description through angiography) is less
than 30% and TIMI grade 3 after PCI; 2. No in-hospital MACE; Technical success is defined
as: The Robot-assisted PCI procedure was successfully completed without any unplanned
manual assistance or shift to manual operation.
5.4.3
Risk observation assessment
The trial protocol requires the investigator to record all adverse events during clinical trial
phases and determine the relevance and severity.
According to the Chinese Guidelines for Percutaneous Coronary Intervention (2016)[20], the
final follow-up of this study was scheduled at 1 month after the procedure and the occurrence
of adverse events was collected during the same period to meet the observation time
requirement of risk infection that may result from the surgical treatment.
5.5 Subject Selection
From October 2024 to September 2026, patients with coronary artery disease requiring PCI
treatment were identified by clinical screening and coronary angiography in the collaborating
medical units (Lopu County People's Hospital, Karamay Central Hospital, and the First
People's Hospital of Kashgar Region).
5.5.1
General Inclusion Criteria
Subjects must meet all of the following inclusion criteria:
1.
18 years of age ≤age ≤80 years of age.
2.
Have clinical indication(s) for PCI and need to be treated with a PCI procedure.
3.
Subjects voluntarily signed an informed consent form and were willing to complete
follow-up visits.
5.5.2
Angiography Inclusion Criteria
1.
Visual description of target lesion diameter stenosis ≥70% (or ≥50% accompanied with

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clinical evidence of myocardial ischemia within that range;
2.
2.0 mm ≤reference vessel diameter by visual description ≤4.0 mm.
3.
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.
4.
≤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;
5.5.3
General Exclusion Criteria
Subjects cannot meet any of the following exclusion criteria:
1.
Subjects have undergone other PCI within 72 hours prior to the R-One PCI procedure;
2.
Subjects have undergone PCI within 30 days prior to the R-One PCI procedure and have
experienced a MACE or other serious adverse event;
3.
Acute MI within one week prior to scheduled R-One PCI procedure;
4.
Severe heart failure (NYHA ≥Class III);
5.
Cardiogenic shock within 48 hours prior to the PCI procedure;
6.
Pregnant and lactating women, or women with plans to become pregnant during the
clinical trial;
7.
Subjects with allergies to aspirin, heparin, clopidogrel, contrast media, metallic materials
and rapamycin;
8.
Subjects with a platelet count <100 x 109/L or >700 x 109/L and a WBC count <3 x 109/L
(e.g., thrombocytopenia, thrombocytosis, neutropenia or leukopenia);
9.
Subjects with creatinine levels ≥177 umol/L;
10. Subjects had a stroke within 30 days prior to the planned R-One PCI procedure.
11. Subjects with an active peptic ulcer or upper gastrointestinal hemorrhage within 6 months
prior to the PCI procedure.
12. Subjects with a history of massive haemorrhage or coagulation disorder, or refusal of
blood transfusion within the previous 6 months.
13. Subjects are currently enrolled in another clinical study that has not yet completed the

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entire follow-up period.
14. The investigators determined that the patient was not applicable for robot-assisted PCI.
5.5.4
Angiography Exclusion Criteria
1.
TIMI blood flow grade of <3 for the target lesion.
2.
In-stent restenosis, or the target vessel has implanted a stent previous which in close
proximity to the target lesion.
3.
Need other treatments (e.g., atherectomy or laser treatment) in addition to balloon
angioplasty and stentoplasty.
4.
Coronary anatomy deemed unsuitable for robot-assisted PCI as determined by the
operator
6
Primary Evaluation Indicators
6.1Clinical success rate of the surgery
6.1.1
Calculation formula:
Clinical success rate = number of subjects that were clinical successes ÷ number of subjects
that received surgical treatment × 100%.
6.1.2
Definition of clinical surgical success:
(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.
6.2Success rate of surgical techniques
6.2.1
Calculation formula:
Technical success rate = number of subjects that were technical successes ÷ number of
subjects received surgical treatment × 100%
6.2.2
Definition of technical success:
(1) The Robot-assisted PCI procedure was successfully completed without any unplanned

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manual assistance or shift to manual operation.
(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
(4) 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
7
Secondary Evaluation Indicators
7.1 Procedure duration
Calculation formula: Procedure duration = arterial sheath removal time - arterial sheath
insertion time.
7.2 Duration of robot-assisted treatment
Calculation formula: Robot-assisted treatment duration = time when the robot finishes
moving the guidewire away from the coronary vessel - time when the robot starts
manipulating the guidewire.
7.3 Radiation exposure to the patient
Evaluation Method: Measure and record dose exposure by angiography (DSA)
7.4 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

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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.
7.5 Contrast dose
Evaluation Method:
Record the contrast dose used during intra-operative angiography
7.6 MACE
Evaluation Method:
Record the in-hospital MACE of subjects
Record the MACE occurred 1 month (30±7 days) after the PCI procedure
8
Product performance indicators
8.1 Intraoperative physiological load evaluation 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.
8.2 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.
8.3 Intraoperative Remote Control Performance Evaluation of surgeons
Evaluation Method:
Both remote and local surgeons are required to promptly complete postoperative subjective

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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.
8.4 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%.
Evaluation Method:
Definition of serious system malfunction: 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.
8.5 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.
8.6 Evaluation of Device Usability
Evaluation Method:
1.
Record the performance of the investigational device from preoperative preparation to
the end of the procedure.
2.
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.
9
Indicators for Safety Evaluation

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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.
10 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.
11 Application method of the investigational device

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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 be independent PCI surgeons and need to be trained and
supervised by the physician who completed the animal experiments using the investigational
device.
12 General procedure of a surgical operation
1.
Connect the power cord to the mains.
2.
Load the instruction unit, ensuring that the positioning mark on the base and that on the
radiation-proof screen overlap.
3.
Switch on the system
4.
Activate the system and simultaneously establish a master-slave connection.
5.
Prepare R-One consumables kit.
6.
Install the instruction unit protective sleeve.
7.
Install the cartridge.
8.
Install the robot.
9.
Attach the Y-connector clip to the cartridge.
10.
Insert the guide wire in the cartridge.
11.
Navigate the guide wire through the instruction unit
12.
Move the control lever and actuate the guidewire
13.
Fix the guidewire
14.
Insert the catheter into the cartridge
15.
Navigate the catheter through the instruction unit
16.
Move the control lever and actuate the catheter
17.
Securing catheter
18.
Simultaneous navigate the guidewire and catheter from the instruction unit

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19.
Place the guide wire in the alternate path as a backup
20.
Place the catheter in the alternate path as a backup
21.
Adjust the robot position
13 Feasibility
13.1
Analysis of subject risks and the probability of trial failure
The trial failure may be caused by the device defects occurred during operation, the
investigator's failure to strictly implement the clinical trial protocol, improper operation and
measurement that are against the protocol, and the high subjects drop-out rate that exceeds the
expectation.
13.2
Analysis of subject benefits and probability of trial success
Since the initial application in 2006, robot-assisted PCI has been shown to be safe and
feasible in simple lesions. With advances in system technology and increased operator
experience, vascular interventional robots are also beginning to be applied to complex, more
“real-world” lesions, where their safety and efficacy have been further validated
[7-13].
However, reducing radiation exposure for the operator is not the sole objective of vascular
interventional robotics. It is also envisioned that robotic surgery can assist in decision-making,
enhance the operator’s operations, further improve surgical safety and efficacy, achieve more
precise treatment targeting, reduce patients' radiation exposure and contrast dose, thereby
benefiting both patients and physicians. The R-One™vascular interventional robot employs
an innovative bionic twisting technology that replicates the hand movements of physicians.
Through mechanical clamping and millimeter-level stepping, it delivers superior motion
stability and high precision, preventing unintended displacement of instruments caused by
operator muscle tremors, fatigue, or mishandling during instrument exchanges. Robotic-
assisted surgery eliminates the limitations of manual methods, such as tremors that may lead
to serious complications, thereby enhancing surgical precision and safety. Simultaneously, it
reduces the need for repeated manipulations and instrument repositioning, consequently

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lowering
patients'
radiation
doses
and
contrast
agent
consumption
[Patent
No.:
CN107847281B;
CN106535808B].
Thanks
to
its
unique
technological
design,
the
introduction and removal of instruments (guidewires and balloon/stent catheters) takes only
one second. The R-One robotic platform can precisely and perfectly replicate hand
movements, ensuring medical staff can execute procedures rapidly. Owing to its intuitive
operation, the R-One platform features a swift learning curve. As early as the 2017 safety
study of this device, medical personnel—without any specialized training—demonstrated that
robotic-assisted PCI differed from manual PCI by merely one minute in procedure time. As
part of using R-One for coronary interventions, interventional cardiologists can operate the
robot via a console behind radiation-proof screens while seated almost entirely. This
significantly improves ergonomic positioning and comfort for healthcare providers. The setup
also enhances surgical visual feedback by enabling closer observation. The control station
features a mobile radiation shield (190 cm height × 152 cm width × 118 cm depth),
accommodating multiple personnel to ensure protection for the entire care team. The secure
execution of interventional procedures substantially reduces stress among medical staff.
Comprehensive protection against radiation exposure prevents occupational injuries, thereby
contributing to improved patient care quality.
5G communication technology, with its advantages of high throughput, low latency, and
massive connectivity, can empower China's medical services toward mobility, remote
operation, and intelligent development when integrated with robotics. This integration enables
the implementation of remote surgery. Therefore, the development of 5G remote surgical
robot system and its regular application can enable surgeons to be free from time and space
restrictions, allowing patients to receive high-quality medical services locally. This is
conducive to the balanced development of high-quality medical resources and truly makes
high-quality medical services accessible to the general public.
The entire development process of this investigational device, from project planning, design
and development to processing and production, has been carried out in strict accordance with
industry standards and regulatory requirements, such as "Application of Medical Device Risk
Management to Medical Devices", to assess the possible risk hazards and take corresponding
control measures to keep the expected risks within acceptable limits as far as possible.

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After the approval and consent of the Medical Ethics Committee for the protocol, the clinical
trial will be carried out in compliance with the requirements of the Norms on the Quality
Management of Medical Devices for the Clinical Trials, the Declaration of Helsinki and other
relevant laws and regulations. The investigator should strictly follow the requirements of each
protocol phase of during the clinical trial process.
Previsou animal experiments and literature studies have approved that tthere is no evidence to
suggest that the investigational device may have more unanticipated adverse events or a
higher risk compared to other vascular nterventional navigation control systems that are on
the market or in clinical trial phase. R-OneTM vascular intervention robot is embedded
software with negligible end-to-end delay. After adding 5G remote robotic surgery function,
risks mainly come from 5G network transmission delay, packet loss and network
disconnection. The remote control module of R-OneTM vascular intervention robot adopts
end-to-end control, remotely transmitting control signals and emergency stop signals. The
operation mode of remote control remains unchanged, achieving continuous signal
transmission, which has good reliability and stability. If the network condition, delay and
packet loss are comprehensively evaluated before the operation and meet the clinical and
technical requirements, remote surgery can be carried out. All instructions are transmitted
continuously, and remote control handle instructions are updated in real time to ensure that
network delay and packet loss do not exceed clinical and technical requirements. In case of
abnormality, network interruption or emergency, it can switch local or local manual operation
with one key. Therefore, under strict implementation of the trial protocol, the potential
benefits of using the investigational device for subjects are greater than the potential risks, and
the clinical trial itself is more likely to be successful.
14 Monitoring and Quality Control of Clinical Trial
The purpose of trial monitoring is to verify that: I. The rights and health of the subjects are
protected; II. The reported trial data are accurate and intact, and can be verified from the
original documents; III. The trial is implemented in accordance with the protocol and in
compliance with the requirements of the clinical trial regulations and relevant applicable

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management procedures.
During the course of this study, the participating researchers must be uniformly trained and
the entire clinical trial shall be conducted under standard operating procedures. The
investigator shall record data into the CRF truthfully, detailed and carefully as per the
requirements for CRF completion to ensure that the contents of the CRF are true, complete
and reliable.
The sponsor will also assign inspectors to regularly visit and monitor research centre on-site
to ensure that all elements in the protocol are strictly adhered to and that the study data are
filled in correctly. The frequency of monitoring will be demonstrated in the monitoring plan.
Monitoring may be also included contacts by correspondence or telephone, as appropriate.
During monitoring visits, investigators must make time to validate data, resolve questions
raised, and verify raw data for inspectors to abtain subjects records.
Definition of source data review and approval: On-site monitoring includes source document
verification (SDV). SDV is the procedure of comparing data in the CRF with the source data
(e.g. various laboratory test results) stored at the institutions, with the aim of verifying their
accuracy. All observations and findings of the clinical trial shall be checked to ensure the
reliability of data and all conclusions are drawn from original data.
General workflow of trial monitoring:
1.
The CRA must notify the investigator and, if necessary, the instituional office prior to
conducting on-site monitoring;
2.
Each monitoring visit needs to confirm that the issues identified in the previous visit
have been resolved;
3.
During the monitoring process, the CRA shall communicate with the investigator in a
timely manner regarding the issues identified;
4.
The CRA shoud submit a written question feedback form to the investigator and, if
necessary, to the institutional office;
5.
The CRA shall urge the investigator to promptly address the problems identified during
the monitoring until they are resolved;
6.
At the end of the monitoring visit, a written monitoring visit report is submitted to the
project leader.

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The specific rules and requirements for the implementation of monitoring are based on the
internal standard operating procedures of the sponsor/CRO company. The monitoring process
shall be conducted in accordance with the relevant requirements of the clinical trial
management department of the study site and in compliance with the national laws and
regulations on clinical trials.
15 Ethical protection and informed consent in clinical trial
15.1 Ethical Considerations
This clinical trial is conducted in strict accordance with the requirements of the Good Clinical
Practice for Medical Devices, the Declaration of Helsinki, other relevant laws and regulations,
and the trial protocol. The clinical trial protocol, informed consent form and their updates and
modifications are subject to the approval of the Ethics Committee before implementation. The
principal investigator is responsible for reporting to the ethics committee, through the clinical
trial management institutions, any modifications of the trial protocol during the course of the
trial as well as severe adverse events or unexpected adverse events that may affect the safety
of the subjects and actually occur during the course of the study.
15.2 Approval of Trial Protocol
This trial protocol is subject to the approval by the Medical Ethics Committee.
15.3 Informed consent process
The investigator shall obtain signed informed consent from subjects participating in the study
after fully explaining the purpose, methods, expected benefits, and potential harms of the trial.
For subjects who are unable to provide legal consent, written informed consent must be
obtained from a legal guardian. If subjects and their legal guardians are unable to read, a
public notary must be present throughout the informed consent discussion. After the subjects
and guardians have verbally consented to participate in the study, the notary signs the

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informed consent form, certifying that the information in the informed consent form has been
accurately interpreted and understood. Investigators also need to declare that the subject can
refuse to participate the study or withdraw the study any time with any reason.
If newly identified safety information is sufficient to cause a significant change in the
risk/benefit evaluation, the informed consent form shall be reviewed and updated when
necessary. All subjects (including patients under remedy) shall be informed about these
information, and provided with a modified consent form to join in the study.
15.4 Text of Informed Consent Form
The contents of the informed consent form may vary across study sites, and only the versions
that have been reviewed and approved by the principal Ethics Committee can be used at any
sites.

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16 Regulations for Reporting Adverse Events and Device Defects
16.1
adverse event
16.1.1
Definition of adverse events
Adverse events (AEs) refer to any adverse medical event that occurred during clinical trials,
whether or not it was considered to be medical device or surgical procedure related.
All AEs that are observed during the trial must be truthfully recorded on the Adverse Event
Form. The investigator shall provide targeted treatment for the AEs and follow up with the
subjects until their associated symptoms disappear or become stable.
16.1.2
Determining the Severity of Adverse Events

Mild: Does not affect daily activities;

Moderate: Affects daily activities;

Severe: Loses the ability to perform daily activities.
16.1.3
Determine
the
relationship
between
adverse
events
and
investigational devices and procedures
The investigator shall
assess
the relationship
between
the adverse
event
and
the
investigational device or surgery according to the following classification criteria:
16.1.3.1 Relevance to the investigational device:

Definitely related: There was a clear temporal logic relationship between the occurrence
of adverse events and use of investigational device, and other causes could be ruled out.

Probably related:
Adverse events occurred concomitantly during the use of the
investigational device, and there exist a possibility that the trial treatment caused the
adverse event.

Possibly related: Some existing evidence shows that the adverse event occurred within a
reasonable time interval after use of the investigational device.

Possibly unrelated: The adverse event did not occur within a reasonable time interval
after the use of the study device.

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
Unrelated: The occurrence of adverse events was related to other diseases, medications
or treatments of the subjects, and did not correlate with the use of the investigational
device.

Cannot judge:
16.1.3.2 Relevance to the surgery:

Definitely related: There was a clear temporal logical relationship between the
occurrence of adverse events and the surgical operation, other causes could be excluded.

Probably related:
Adverse events occurred concomitantly during the use of the
investigational device, and there exist a possibility that the trial treatment caused the
adverse event.

Possibly related: Some existing evidence shows that the adverse event occurred within a
reasonable time interval after use of the investigational device.

Possibly unrelated: The adverse event did not occur within a reasonable time interval
after the use of the study device.

Unrelated: The occurrence of the adverse event was related to other diseases, medication
or treatment of the subject, and did not correlate with the surgical operation.

Cannot judge:
16.2
Serious adverse events
16.2.1
Definition of serious adverse events
The adverse events observed during clinical trials usually include: death, life-threatening,
hospitalization required or prolonged hospitalization, disability, affect the ability to work, or
cause congenital deformities, etc. Medical events that have not yet resulted in death, are not
yet life-threatening, or do not yet require hospitalization, may be considered as severe adverse
events if they are judged by the investigator to be potentially harmful to the subjects and
preventable by medication or surgical treatment.
16.2.2
Management and reporting of serious adverse events
When a severe adverse event is observed during the clinical trial, regardless of its relationship
to the investigational device, the investigator shall immediately provide appropriate treatment

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to the subjects and record the event in the CRF. The investigator shall also complete a Severe
Adverse Event Report Form, submit a written report to the medical device management
department of the clinical trial institution, and notify the sponsor in writing of the following
contact information: The administrative departments for clinical trials of medical devices shall
report in writing within 24 hours to the corresponding ethical committees, and the competent
departments of the provincial, municipal and autonomous region Medical Products
Administrations and Health Commissions where the clinical trial institutions are located. In
terms of fatality, clinical trial institutions and investigators should provide the ethics
committee and sponsors with all the information they need.
16.3
Anticipated Adverse Events
Anticipated adverse events are those whose occurrence can be predicted due to the subject's
disease conditions, surgical procedure or study device.
16.3.1
Adverse events that may result from percutaneous coronary
intervention
Adverse events that may result from general PCI surgery and anesthesia include, but are not
limited to, the following[11][20][22]:

Angina pectoris

Myocardial infarction

Myocardial infarction recurrence

Acute coronary artery occlusion

No-reflux

Coronary artery perforation

In-stent thrombosis

Stent dislodgement

Haemorrhage (Bleeding)

Vascular complications

Contrast-induced acute kidney injury

Major adverse cardiovascular events (MACE) (including readmission 12 months after

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surgery, angina recurrence, revascularization, in-stent thrombosis, and cardiac death)[23]

Adverse reactions to anesthesia (headache, muscular pain and nausea)

Allergic reaction

Death
16.3.2
Adverse events that may result from investigational device
No clear evidence has been found that the investigational device may cause more adverse
medical events than comparable products in the normal clinical settings. However, in the
event of violation operation by the user, it may result in accidental injury to the user or patient.
16.4
Treatment of adverse events
When adverse events occur to subjects during the period of clinical trial, they should be
treated according to the symptoms. The investigator need to evaluate the severity of the
adverse event, their correlation with the investigational device and surgical procedures, put
forward suggestions for further treatment, and then fill the adverse event sheet log in time.
Complications of PCI procedures (including robot-assisted PCI procedures) are usually
related to surgical site, surgical approach, and intra-operative surgical proficiency. Adequate
pre-operative preparation, fully understanding of anatomical variants, rational selection of
surgical route, standardized surgical operation, and sound post-operative management are key
to prevent and treat complications of PCI procedures.
16.4.1
Acute coronary artery occlusion
Most acute coronary occlusions occur during the operation or before leaving the catheter lab,
and may also occur 24 h after the surgery. Occlusion of the major or large branches can lead
to serious consequences, such as immediate blood pressure drop, decreased heart rate, and
even ventricular fibrillation and ventricular arrest which may quickly cause death.
All of the above-mentioned conditions should be treated promptly or through stents
implantation to restore coronary blood flow as soon as possible.

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16.4.2
No-reflux
It's recommended to inject intracoronary tirofiban[24][25], calcium channel blockers[26], nitrates,
nitroprusside, adenosine, apply thrombus aspiration[27]or implant IABP, which may help to
prevent or mitigate no-reflow and stabilize hemodynamics. With regard to administration site,
tirofiban administered via a perfusion catheter far from the coronary target lesion can better
improve myocardial perfusion in patients without no-reflow compared to coronary oral
administration[28].
16.4.3
Coronary artery perforation
Coronary artery perforation is a rare but very dangerous complication. When perforation
occurs, a balloon with matching diameter can be used firstly at the perforation site to perform
low-pressure dilatation and occlusion. It's not recommended to occlude coronary artery with
large blood supply for long time, better intermittently, which is often effective for small
perforations,
If the perforation is large or low-pressure balloon dilatation occlusion fails, it's recommended
to implant coated stent graft at the perforation site, and suspend the use of platelet membrane
glycoprotein IIb/IIIa receptor inhibitor in preparation for pericardial puncture. Monitor the
activated clotting time (ACT) and apply fisetin to neutralize heparin if necessary.
If intervention fails to occlude the breach, emergency surgery should be performed.
If cardiac tamponade occurs, pericardiocentesis or pericardiotomy should be performed
immediately for drainage while maintaining the stability of hemodynamics at the same time.
Coronary perforations caused by guide wires are prone to induce delayed pericardial
tamponade, and need to be closely monitored. If the perforation is large, it need to be
occluded with autologous fat particles or coils if necessary.
Regardless of the type of the
perforation, postoperative echocardiogram follow-up should be performed to prevent the
occurrence of delayed pericardial tamponade.
16.4.4
Stent thrombosis
Although the incidence rate of stent thrombosis is low (0.6% within 30 d and 2.9% within 3
years)[29], its mortality rate is as high as 45%[29]. The main risk factors associated with stent

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thrombosis include: （1 ）
Patients at risk: (e.g., diabetes, renal insufficiency, cardiac
insufficiency, high residual platelet reactivity, premature discontinuation of DAPT; (2) high-
risk lesions: Such as type B2 or C complex coronary lesions, complete occlusions, thrombosis
and small vessel diffuse lesions; (3) operation factors: Implantation of multiple stents, long
stents, poor stent apposition, stent overlapping, Crush technique, small stent diameter or small
internal lumen diameter, stent structural deformation, bifurcated stent, persistent postoperative
slow blood flow, positive vessel remodeling, incomplete lesion coverage, or entrapment tears;
(4) Stent-related factors: Allergy to stent coatings or polymers, stent-induced local vasular
inflammatory reaction, stent fracture, delayed endothelialization.
Precautions of in-stent thrombosis includes: （1）Adequate preoperative and perioperative
DAPT and anticoagulation, and GPI for high-risk patients or lesions after adequately evaluate
the hemorrhage risks and benefits. （2 ）
Select the appropriate intervention treatment
approach.
Treatments such as balloon dilation, BMS, or DES implantation should be
selected based on the evaluation of the advantages and disadvantages; stent apposition need to
be as good as possible, high pressure release stents (with optional post-dilatation balloons if
necessary) are recommended to minimize damage to the vessels at both ends of the stent;
IVUS guidance can be used for selected patients. （3）Adequate use of DAPT during the
postoperative period is emphasized.
Once stent thrombosis occurs, coronary angiography should be performed immediately
through recommended IVUS or OCT to clarify the cause of stent failure. Patients with high
thrombus load can be treated by thrombus aspiration, and GPI continuous intravenous
infusion for 48h. Balloon dilation or stents reimplantation is still the main treatment method.
Intracoronary thrombolytic therapy can be applied if necessary. Platelet function should be
tested to understand whether there is high residual platelet reactivity, so as to adjust
antiplatelet therapy. Patients with recurrent and refractory stent thrombosis can be treated with
surgical treatment if necessary.
16.4.5
Stent dislodgement
Stent dislodgement is less common and is most often seen in the following conditions: lesions
that have not been adequately pre-dilated (or direct stenting), vessels have proximal tortuosity

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(or the stent has been implanted), when the stent crosses a stenosis or calcified lesion with too
much force and the stent pushes too hard, when stent implantation fails, and due to poor
coaxiality of the stent with the guideline catheter or poor loading of the stent with the balloon,
the stent dislodges when being retracted into the guide catheter. Adequate preoperative
predetermination of lesion characteristics and pretreatment of lesions (e.g., pretreatment of
calcified lesions by atherectomy) is an effective means to prevent stent dislodgement.
When stent dislodgement occurs and the guide wire is still in the stent lumen, a small balloon
≤1.5 mm in diameter can be delivered via the guide wire to the remote end of the stent,
slightly dilate, and withdraw the stent slowly into the guiding catheter.
If the stent cannot be withdrawn into the guiding catheter due to proximal deformation, try to
use a new guiding catheter with a larger OD; or use a grasper via another vascular route to
capture and remove the stent.
If the above-mentioned methods do not work, the stent can be released in situ by a balloon
with a diameter of 1:1 to the blood vessel delivered through the guidewire,
or implant
another stent and form stent-in-stent appostion
Surgery can performed to remove the
dislodged stent if necessary.
16.4.6
Haemorrhage (Bleeding)
Perioperative haemorrhage is a major risk factor of death and other serious adverse events[31].
Massive hemorrhage (including cerebral bleeding) may lead directly to death, and
discontinuation of antithrombotic drugs after hemorrhage may also lead to thrombotic events
and even death.
Precautions for hemorrhage include: All patients should be assessed for risk of bleeding
before PCI (I, C), and the CRUSADE score is recommended; the radial artery route is
recommended (I, A); patients with high bleeding risk (e.g., renal insufficieny, old age, history
of bleeding, and low body weight), antithrombotic drugs with less bleeding risk, such as
bivalirudin and sulforaphane sodium are preferred during peri-operation; adjust anticoagulant
dose based on body weight during PCI ; monitor ACT to avoid over-anticoagulation.
The decision to discontinue or adjust antiplatelet and anticoagulant medications after bleeding
needs to be weighed individually according to the risk of hemorrhage and recurrent ischemic

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events. Hemorrhage is usually treated with general non-pharmacological hemostatic measures,
such as mechanical compression to stop bleeding; record the time and dose of the last
anticoagulant or thrombolytic drug, and the presence of hepatic and renal impairment;
estimate the half-life of the drug; assess the source of bleeding; test the complete blood counts,
coagulation indicators, fibrinogen concentration and creatinine concentration; test the
antithrombotic activity of the drug when conditions permit; patients with unstable
hemodynamics can be treated with intravenous rehydration and erythrocyte transfusion; treat
local hemostasis with endoscopic, interventional, or surgical methods if necessary; and
suspend antithrombotic drugs as soon as possible if the risk of bleeding is greater than the risk
of ischemia.
If the above-mentioned methods do not work, further medication may be used. Infuse fisetin
to neutralize heparin, with the dose of sulfate fisetin 1mg/80~100U heparin, and the total dose
less than 50mg generally; fisetin can neutralize 60% low molecular-weight heparin (LMWH).
Patients who administerred LMWH in less than 8h can inject sulfate fisetin 1mg/100U anti-
Xa activity, and 0.5mg/100U anti-Xa activity can be added when there is no effect.
After
stopping aspirin or tigretol for 3 d and clopidogrel for 5 d, the risk of bleeding and recurrent
ischemic events should be evaluated again and moderate antithrombotic therapy should be
resumed at the appropriate time[32][33].
16.4.7
Vascular complications
The vascular complications are mainly related to the puncture site, and the risk factors include
female, age ≥70 years, body surface area <1.6 m2, emergency intervention, peripheral
vascular diseases and perioperative application of GPI[34][35].
The major complications of femoral artery puncture and their precautions are as follows. （1）
Puncture site and retroperitoneal hematoma. Small local bleeding or hematoma that is
asymptomatic can be left untreated. Large hematoma, massive bleeding and decreased blood
pressure should be treated with adequate pressure to stop the bleeding and transfuse
appropriate amount of fluid or blood. If hypotension (with or without abdominal pain and
local hematoma formation) occurs within a short period of time after PCI, retroperitoneal
hemorrhage may be suspected, and ultrasound or CT should be performed if necessary, with

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prompt transfuse of adequate blood. （2）Pseudoaneurysm Doppler ultrasound can provide
a definitive diagnosis, and most pseudoaneurysm will be closed by applying local
compression bandages and reducing lower extremity activity.
Larger pseudoaneurysms that
cannot be healed by compression may be treated with ultrasound-guided injection of small
doses of thrombin into the aneurysm. A few require surgical treatment. （3）Arterio-venous
fistula A small percentage may close on their own, or by applying local compression, but large
arteriovenous fistulas often require surgical repair. （4 ）
Arterial entrapment and/or
occlusion. It can be caused by damage to the endothelium of the vessel by guide wires,
catheters
or
plaque
detachment.
Precaution
methods
include
low resistance
and/or
fluoroscopic pushing of guidewires and catheters.
The main complications of radial artery puncture and their precautions are as follows. （1）
Postoperative radial artery occlusion: The incidence rate is less than 5%. Routine preoperative
Allen test to check the traffic of radial and ulnar arteries, adequate intraoperative
anticoagulation, and timely postoperative decompression can effectively prevent radial artery
occlusion and hand ischemia after PCI. （2）Radial artery spasm: is more common, and the
probability is increased due to inadequate anesthesia during puncture, coarse and rigid
instruments, poor operation, or guidewire entering branches.
When radial artery spasm
occurs, it is strictly forbidden to remove the catheter by force , and need to treat by
administration
of
200-400ug
nitroglycerin,
200-400ug
verapamil,
or
5mg
diltiazem
(repeatedly if necessary) via intraarterial sheath until the spasm is relieved before proceed
with the operation.
（3）Forearm hematoma: due to perforation of a small radial branch
caused by hydrophilic-coated guidewire or inappropriate application of a radial artery
compressor; precautions include pushing the guidewire under fluoroscopy; and radial
arteriogram if there is resistance. Postoperative local compression should be aware of the
puncture site. （4）Fascial gap syndrome: is rare but has serious consequences. When the
rapid progression of the forearm hematoma causes increased pressure in intraosseous
membrane to a certain extent, it often leads to compression of the radial and ulnar arteries and
the median nerve, which in turn leads to ischemia and necrosis of the hand. Therefore,
surgical treatment should be performed as soon as possible once the syndrome occurs. （5）
Pseudoaneurysm the incidence rate is less than 0.01%[36], and surgical treatment is feasible if

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local compression does not work.
17 Terms of trial
Prior to the study, the sponsor should sign a clinical trial agreement with the clinical trial site
and the principal investigator, which will describe the financial information, responsibilities
and obligations of each party participating in study.
Under the compliance of relevant laws, regulations and the provisions of the test protocol,
separate agreement with each research institution can be made on specific terms according to
the actual situation.
17.1
Principle of confidentiality
Investigators shall ensure patients keep anonymous and prevent any un-authorized privacy
disclosure. Subjects' information on CRF or other documents submitted to sponsor could be
anonymous which means to replace patient names with IDs.
Research centers and investigators shall be responsible for the confidentiality of the clinical
trial protocol, the investigator's manual, the investigational device, the completed CRF,
laboratory reports, study data and results, and any information relating to the study device.
Research centers and investigators will only use the relevant information to fulfill the duties
of the clinical trial protocol or agreements (for example, to provide the necessary explanations
to potential participants of the study in order to obtain informed consent form). The above
information shall not be disclosed to any third party not related to this study without the
written consent of the sponsor, except in the case of inspection by a higher regulatory
authority or as specifically agreed in the test protocol.
17.2
Agreement on publication of trial results
Researchers who need to use research materials independently and publish articles must
comply with relevant laws and regulations. The agreement on the publish of trial results will
be specified in the protocol signed by the sponsor and the research center. The sponsor has the
right to obtain a manuscript or abstract of the relevant article before the researcher submits it
for publication.

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17.3
Insurance
In case of any investigational device-related injury, the Sponsor need to provide the treatment
cost and corresponding economic compensation to the subject. Related costs may also be
reimbursed by the medical device clinical trial insurance purchased by the sponsor for this
trial.
Specific compensation methods and deductibles will be agreed in the test agreement and the
insurance agreement.
18 Rights and responsibilities of the parties
18.1
Subjects' rights
1.
The trial must firstly be approved by the ethics committee before initiation.
The ethics
committee approval or consent document (which includes the name of this trial protocol)
shall be marked with the approval content and date of the ethics committee. This
requirement applies whenever there is a subsequent amendment/change to the
programme.
2.
All subjects were required to understand the purpose, methods, surgical effects, and
potential adverse effects of the trial, voluntarily participate in the trial, and sign a written
informed consent form.
3.
Subjects have the rights, as stated in the informed consent form, to withdraw from the
trial at any time if they wish to do so without interfering with their normal medical
treatment.
4.
If a subject occurs an adverse event related to the investigational device during the study,
the additional costs required will be covered by the sponsor or clinical trial insurance in
accordance with the study contract.
5.
The clinical trial sites shall ensure that the medical monitoring system is working
properly and that subjects can contact the study physician at any time in need and receive
prompt medical consultation and treatment and, if necessary, hospitalization.

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6.
Emphasize the responsibilities of medical personnel at all levels, pay attention to clinical
observation, and ensure the safety of the subjects.
7.
Adverse events in subjects should be dealt with in a timely manner, and those events
related to investigational device must be followed-up until the symptoms disappear or
are corrected to clinically acceptable conditions.
8.
In case of serious adverse events, efforts should be mobilized for active treatment and
report in writing to the ethics committee, the sponsor and the relevant health supervision
and management authorities within a specified period of time.
18.2
Assume
institutional
and
investigator
responsibilities
for
clinical trials
Before joining in a clinical trial, a clinical trial site should evaluate the relevant resources
according to the characteristics of the investigational device to decide whether to participate
or not.
Clinical trial sites shall maintain proper clinical trial records and essential documents as
agreed with the sponsor, including but not limited to:
(1)
Clinical trial protocol and its annexes approved by the ethics committee
(2)
Clinical Trial Agreements
(3)
Ethical approval
(4)
Investigator qualification documents
(5)
Sample signature of investigator and responsibilities division form
(6)
Monitoring records
(7)
CRF sample form and its updates
(8)
Subject screening enrollment registration form
(9)
Protocol deviation records
(10) Adverse events record
(11) investigational device usage records
(12) Trial summary report
(13) Original documentation of each subject:

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
Signed informed consent form

Completed Case Report Form (CRF) and Data Clarification Form (DCF)

Adverse event reporting documents

Documentation of relevant laboratory test reports
Before the clinical trial, the administrative department of clinical trial for medical devices of
the clinical trial sites shall cooperate with the sponsor to submit an application to the ethics
committee as well as relevant documents in accordance with the regulations.
According to the needs of the clinical trial, the investigator can authorize corresponding
personnel to carry out subjects enrollment, continue communication with subjects, record
clinical trial data, and manage investigational device management. The investigator should
train and document their authorized personnel accordingly.
The investigator shall ensure that the relevant staff involved in the trial are familiar with the
principle, application range, product performance, operation method, installation requirements
and technical indicators of the investigational device, understand the preclinical study data
and safety data of the investigational device, and master the prevention and emergency
methods that may arise from the clinical trial.
The investigator shall ensure that the investigational device is used only on subjects in the
clinical trial and shall not charge any fees.
Investigators should strictly follow the clinical trial protocol and should not deviate from it or
materially change it without the consent of the sponsor and the ethics committee. However, in
emergency situations requiring immediate attention, such as when the subject is in immediate
danger, changes may also be reported in writing afterwards.
The investigator was responsible for enrolling subjects, talking to subjects or their guardians.
It is the responsibility of the investigator to explain the investigational device and the details
related to the clinical trial to the subject, to inform the subject of the possible benefits and
known or foreseeable risks, and to obtain signed and dated informed consent from the subject
or his or her guardian.
When an investigator discovers an unanticipated adverse event related to the investigational
device in a clinical trial, he or she should work with the sponsor to revise the relevant contents
of the informed consent form, report to the ethics committee for review and approval in

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accordance with the relevant working procedures, and have the affected subject or his or her
guardian re-sign the revised informed consent form for confirmation.
The investigator is responsible for making medical decisions related to the clinical trial, and in
the event of an adverse event related to the clinical trial, the clinical trial site and the
investigator should ensure that adequate and timely treatment and management is provided to
the subject.
If serious adverse events occur in clinical trials, the investigators should immediately take
appropriate treatment measures for the subjects. Meanwhile, they should report in writing to
the management department of clinical trials of medical devices in the clinical trial
institutions and notify the sponsors in writing through their clinical trial institutions. The
administrative departments for clinical trials of medical devices shall report in writing within
24 hours to the corresponding ethical committees, and the competent departments of the
provincial, municipal and autonomous region Medical Products Administrations and Health
Commissions where the clinical trial institutions are located. In terms of fatality, clinical trial
institutions and investigators should provide the ethics committee and sponsors with all the
information they need.
Responsibilities of investigators: investigators should record all adverse events and instrument
defects found in clinical trials, analyze the causes of the events together with the sponsors,
form a written analysis report, put forward opinions on continuing, suspending or terminating
the trials, and submit them to the Ethical Committee for review by the management
department of clinical trials of medical devices in clinical trial institutions.
Investigators should ensure that clinical trial data are accurately, completely, clearly and
timely included in the case report forms. The name of the case report form shall be signed by
the investigator. Any data change shall be signed by the investigator and the date shall be
marked. At the same time, the original record shall be kept, and the original record shall be
clearly identifiable.
Clinical trial institutions and investigators shall ensure that data, documents and records of
clinical trials are true, accurate, clear and safe.
Clinical trial institutions and investigators should be monitored, audited by the sponsors and
supervised by ethical committees, and provide all required records related to the trial. Clinical

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trial institutions and investigators shall cooperate with the inspectors from the NMPA or
Health Commission for inspection.
When clinical trial institutions and investigators find that the risks outweigh the possible
benefits or that results sufficient to judge the safety and efficacy of the investigational device,
and it is necessary to suspend or terminate the clinical trial, they shall notify the subjects and
ensure that they receive appropriate treatment and follow-up, as well as report and provide
detailed written explanations in accordance with the regulations. If necessary, report to the
food and drug supervision and management department of the province, autonomous region
or municipality directly under the Central Government where it is located.
At the end of the clinical trial, the investigator should ensure that the records, reports are
completed. The investigator should also ensure that the quantity of investigational devices
received for the trial match the quantity used, discarded or returned, and that the remaining
investigational devices are properly disposed of and documented.

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19 Appendices
19.1
Local Discomfort Experience Scale
Center No.:
|__|__|
Subjects Screening Number:
|__|__|__|
Initials:
|__|__|__|__|
Enrollment
number:
|__|__|__|
10
Very uncomfortable
Please (the surgeon) score the discomfort degree of the
body parts indicated by the letters in the diagram after
the operation:
9
8
Very uncomfortable
7
A
__________
I
__________
6
Relatively
uncomfortable
B
__________
J
__________
5
C
__________
K
__________
4
Some uncomfortable
D
__________
L
__________
3
E
__________
M
__________
2
Little uncomfortable
F
__________
N
__________
1
G
__________
0
No discomfort at all.
H
__________
Left
Right

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Investigator (surgeon)/authorized recorder:
____________________________________
|__|__|__|__|year|__|__|months|__|__|days
19.2
Subjective Mental Load Scale
Center No.:
|__|__|
Subjects Screening Number:
|__|__|__|
Initials:
|__|__|__|__|
Enrollment
number:
|__|__|__|
Please rate the degree of difficulty in completing this procedure based on the scale illustration
and select a number on the anchor point for the final rating.
0
10
20
30
40
50
60
70
80
90 100 110 120 130 140 150
Not difficult at all.
Not very difficult.
It's a little difficult.
Some difficulties
Difficult
fairly difficult
Very Difficult
Very, very difficult.
extremely difficult
Rating: ______________
Investigator (surgeon)/authorized recorder:
____________________________________
|__|__|__|__|year|__|__|months|__|__|days

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19.3
Device Performance Evaluation Form
Center No.:
|__|__|
Subjects Screening Number:
|__|__|__|
Initials:
|__|__|__|__|
Enrollment
number:
|__|__|__|
Main types of
surgery:
□Robot-assisted PCI
□Tele-Robot-assisted PCI
Start to move the
guidewire away
from the guiding
catheter:
Begin
time:
|__|__|hours|__|__|minutes
Finished
at:
|__|__|hours|__|__|minutes
Terminate the
movement of
guidewire from
the coronary
vessels.
Begin
time:
|__|__|hours|__|__|minutes
Finished
at:
|__|__|hours|__|__|minutes
Device performance evaluation:
Overall usage experience
of the system:
□Excellent
□Good
□Moderate
□Bad
The flow performance of
instruction unit:
□Excellent
□Good
□Moderate
□Bad
The
visual
effects
of
radiation-proof screen:
□Excellent
□Good
□Moderate
□Bad
The moving performance
of the robotic arm
□Excellent
□Good
□Moderate
□Bad
The operating performance of the surgical device:
(If there were device replacement
during the surgery, please evaluate the one with the lowest performance)
Cartridge:
□Excellent
□Good
□
□Bad
□Not used

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Moderate
The protective sleeve
of the instruction unit:
□Excellent
□Good
□
Moderate
□Bad
□Not used
Other (_________):
□Excellent
□Good
□
Moderate
□Bad
□Not used
Other (_________):
□Excellent
□Good
□
Moderate
□Bad
□Not used
Intraoperative
hemorrhage
estimates:
|__|__|__|__| mL
Whether the intended purpose of robotic-
assisted surgical treatment is accomplished.
□Yes
□No
Investigator (surgeon)/authorized recorder:
____________________________________
|__|__|__|__|year|__|__|months|__|__|days

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19.4
System malfunction Record Form
Center No.:
|__|__|
Subjects Screening Number:
|__|__|__|
Initials:
|__|__|__|__|
Enrollment number:
|__|__|__|
□System malfunction occurred during
surgery
□No system malfunction during the operation
Occurrence
Time:
|__|__|hours|__|__|minutes
□
Serious
malfunctions
□Repairable malfunction
□Instruction unit
□Robot
□Support joint arm
□
Mobile
radiation-proof
screen
□Cartridge
□Protective sleeve of the
instruction unit
Location
of
malfunction:
Malfunction
description:
Treatment measures
and results:
□Malfunction
is
resolved
□Change devices
□
Malfunction
not
repaired
Impact on surgery:
□No visible effect
□
Increase
surgery
duration
□
Surgical
option
conversion
Occurrence
Time:
|__|__|hours|__|__|minutes
□
Serious
malfunctions
□Repairable malfunction
□Instruction unit
□Robot
□Support joint arm
□
Mobile
radiation-proof
screen
□Cartridge
□Protective sleeve of the
instruction unit
Location
of
malfunction:
Malfunction
description:

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Management
measures and results
□Malfunction
is
resolved
□Change devices
□
Malfunction
not
repaired
Impact on surgery:
□No visible effect
□
Increase
surgery
duration
□
Surgical
option
conversion
Occurrence
Time:
|__|__|hours|__|__|minutes
□
Serious
malfunctions
□Repairable malfunction
□Instruction unit
□Robot
□Support joint arm
□
Mobile
radiation-proof
screen
□Cartridge
□Protective sleeve of the
instruction unit
Location
of
malfunction:
Malfunction
description:
Management
measures and results
□Malfunction
is
resolved
□Change devices
□
Malfunction
not
repaired
Impact on surgery:
□No visible effect
□
Increase
surgery
duration
□
Surgical
option
conversion
Investigator (surgeon)/authorized recorder:
____________________________________
|__|__|__|__|year|__|__|months|__|__|days
19.5
NYHA Classification:
ⅠLevel: Patients have heart disease, but there is no restriction on the amount of activity in their
schedule. General physical activity does not cause excessive fatigue, palpitations, shortness of
breath, or angina.
ⅡLevel: Patients with heart disease have a slight restriction in physical activity and have no
conscious symptoms at rest, but may experience fatigue, palpitations, shortness of breath, or
angina under usual general activity.
ⅢLevel: Physical activity is significantly limited in patients with heart disease. Less than

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usual general physical activity can cause fatigue, palpitations, shortness of breath or angina.
ⅣLevel: Patients with heart disease are unable to engage in any physical activity, and
symptoms of heart failure occur even at rest and worsen with physical activity.

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Cathbot (Shanghai) Robot Co., Ltd.
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CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
R-OneTM vascular interventional navigation control system
Version No.: 1.0 / Version Date: 2025-03-01
Cathbot (Shanghai) Robot Co., Ltd.
Statement of the Investigator
I hereby agree:
1.
to conduct this clinical trial in strict accordance with the Declaration of Helsinki, existing
laws and regulations in China, and the requirements of this trial protocol.
2.
to accurately record all required data on the Case Report Form (CRF) and complete the
clinical trial summary report on time.
3.
The investigational device will be used only for this clinical trial, and the receipt and use
of the investigational device will be recorded completely and accurately during the
clinical trial, and records will be kept.
4.
to allow the monitors and inspectors authorized or dispatched by the applicant and
regulatory departments to audit, verify and inspect the clinical trial.
5.
to strictly abide by the clinical trial contract / agreement signed by the parties.
I have read all contents of the clinical trial protocol, including the above statements, and I
agree with all of the above.
Sponsor's opinions:
Signature (or stamp):
Date:
Investigator's Opinion:
Signature
Date:

CATHBOT-2021-R-One-Effectiveness and safety evaluation of cardiology robot-assisted percutaneous coronary interventions using the
R-OneTM vascular interventional navigation control system
Version No.: 1.0 / Version Date: 2025-03-01
Cathbot (Shanghai) Robot Co., Ltd.
Comments of clinical trial institution of medical devices:
Signature (or stamp):
Date: