A Prospective, Multicenter, Randomized Control, Non-inferiority to Investigate the Effectiveness and Safety of SINOMED CBC for Endovascular Treatment of Stenotic Coronary Artery Disease
Phase: NA
Conditions: Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
Sponsor: Sino Medical Sciences Technology Inc.

 
 
Page 1 of 48 
Protocol No.: SN-CBC-202201 
 
 
A Prospective, Multicenter, Randomized Controlled Study 
to Evaluate the Safety and Effectiveness of Coronary 
Scoring Balloon Catheter for the Treatment of Coronary 
Artery Disease 
 
Clinical Trial Protocol 
 
(NCT05509296) 
 
Name of Investigational Medical Device:
Coronary Scoring Balloon Catheter 
Models/Specifications:
2.0-3.5 mm in diameter, 10-15 mm in
length 
Class III Medical Device Requiring 
Clinical Trial Approval:
Yes  No 
Protocol Version No. and Date:
V1.1/June 01, 2022 
Study Site:
Peking University First Hospital 
Principal Investigator:
Professor Li Jianping 
Leading Site/Coordinating Investigator of
Clinical Trial:
Peking University First Hospital/Professor
Li Jianping 
Sponsor:
Sino Medical Sciences Technology Inc. 
 
 
 
 
Statement of Confidentiality 
All information contained in this protocol is the proprietary information of Sino Medical Sciences 
Technology Inc. and is only available for review by the investigator, the coordinating investigator, Ethics 
Committee (EC), supervisory and regulatory authorities and other relevant medical institutions. Without 
the written approval of the sponsor, any information cannot be disclosed to any third party not associated 
with the study unless this disclosure is made to make the subjects who may participate in the study sign the 
informed consent form (ICF). 

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Table of Contents 
Table of Contents ................................................................................................ 2 
Protocol Abstract ................................................................................................ 5 
1. 
Sponsor Information ................................................................................. 9 
1.1 
Name of Sponsor ............................................................................. 9 
1.2 
Address of Sponsor ......................................................................... 9 
1.3 
Contact Information of Sponsor ................................................... 9 
2. 
Information on Study Sites and Principal Investigators ....................... 9 
3. 
Background Information of Clinical Trial ............................................. 9 
3.1 
R&D Background ........................................................................... 9 
3.2 
Basic Information of Product ...................................................... 10 
3.3 
Intended Use and Related Information ...................................... 12 
4. 
Study Objective ....................................................................................... 14 
5. 
Study Design ............................................................................................ 14 
5.1 
Overall Design and Its Determination Basis .............................. 14 
5.2 
Subject Enrollment ....................................................................... 15 
5.2.1 
Inclusion Criteria.............................................................. 15 
5.2.2 
Exclusion Criteria ............................................................. 15 
5.2.3 
Criteria and Procedures for Subject Withdrawal ......... 16 
5.2.4 
Criteria 
and 
Procedures 
for 
Discontinuation or 
Termination of the Trial .................................................. 17 
5.3 
Evaluation Methods ...................................................................... 18 
5.3.1 
Effectiveness Evaluation .................................................. 18 
5.3.2 
Safety Evaluation .............................................................. 19 
5.4 
Investigational Medical Device and Control Device ................. 20 
5.5 
Study Process ................................................................................ 22 
5.5.1 
Study Flowchart................................................................ 22 
5.5.2 
Conduct of Clinical Trial ................................................. 22 
5.5.3 
Norms for Using Device ................................................... 24 
5.5.4 
Specifications 
for 
Concomitant 
Therapy 
(e.g., 
Medication) ....................................................................... 24 
5.6 
Measures to Control Bias ............................................................. 25 
6. 
Statistical Considerations ....................................................................... 25 
6.1 
Estimation of Sample Size ............................................................ 25 
6.1.1 
Overall Sample Size .......................................................... 26 
6.1.2 
Allocation of Sample Size ................................................. 26 
6.1.3 
Minimum and Maximum Number of Subjects in Each 
Site and Justification ........................................................ 26 
6.2 
Analysis Data Sets ......................................................................... 27 
6.3 
Subject Elimination Criteria ....................................................... 27 
6.4 
Statistical Methods ....................................................................... 27 

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6.4.1 
Statistical Design ............................................................... 27 
6.4.2 
Statistical Analysis Methods ............................................ 28 
6.4.3 
Significance Level and Power of Clinical Study ............ 29 
6.4.4 
Expected Drop-out Rate .................................................. 29 
6.4.5 
Pass/Fail Criteria for Clinical Trial Results .................. 29 
6.4.6 
Criteria for Termination of Trial Based on Statistics and 
Justification ....................................................................... 29 
6.4.7 
Procedures for Reporting Deviation from Original 
Statistical Plan .................................................................. 29 
6.5 
Missing Data and Outliers ........................................................... 30 
7. 
Monitoring Plan ...................................................................................... 30 
8. 
Data Management ................................................................................... 31 
8.1 
Data Collection .............................................................................. 31 
8.2 
Data Verification and Modification ............................................ 31 
8.3 
Database Locking ......................................................................... 31 
9. 
Risk-Benefit Analysis .............................................................................. 32 
9.1 
Benefit Analysis ............................................................................. 32 
9.2 
Potential Risk Analysis ................................................................. 32 
10. 
Quality Control of Clinical Trial ........................................................... 32 
11. 
Ethical Issues and Informed Consent in Clinical Trial ....................... 33 
11.1 Ethical Considerations ................................................................. 33 
11.2 Informed Consent Process ........................................................... 33 
12. 
Provisions for AE and Device Defect Reporting .................................. 34 
12.1 Definition of AE and Provisions for AE Reporting ................... 34 
12.2 Device Defect ................................................................................. 34 
12.3 Definition of SAE .......................................................................... 35 
12.4 Reporting Procedures and Contact Information ...................... 35 
13. 
Deviation from Clinical Trial Protocol and Regulations for Protocol 
Amendment ............................................................................................. 36 
14. 
Direct Access to the Source Data and Documents ............................... 36 
15. 
Contents to be Covered in Clinical Trial Report ................................. 36 
16. 
Confidentiality Principle ........................................................................ 37 
17. 
Responsibilities Assumed by All Parties ............................................... 37 
17.1 Responsibilities of Investigators .................................................. 37 
17.2 Responsibilities of Medical Device Clinical Trial Institutions . 38 
17.3 Responsibilities of Sponsor .......................................................... 39 
18. 
Other Contents to Be Addressed ........................................................... 41 
19. 
References ................................................................................................ 41 
Investigator's Statement ................................................................................... 44 
Appendix 1 List of Study Sites and Principal Investigators ......................... 45 
Appendix 2 List of Contact Information for AE and Device Defect Reporting
 ............................................................................................................................. 45 

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Appendix 3 Definition of Composite Endpoint .............................................. 45 
Appendix 4 Definition of Death ....................................................................... 45 
Appendix 5 Myocardial Infarction (MI) (UD 2018) [21] ................................. 46 
Appendix 6 Definition of Revascularisation ................................................... 47 
 
 
 

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Protocol Abstract 
Study Title 
A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Safety and 
Effectiveness of Coronary Scoring Balloon Catheter for the Treatment of Coronary 
Artery Disease 
Study 
Objective 
To evaluate the safety and effectiveness of Coronary Scoring Balloon Catheter 
manufactured by Sino Medical Sciences Technology Inc. in the treatment of coronary 
artery stenosis 
Test Devices 
 Investigational Medical Device: 
Product Name: Coronary Scoring Balloon Catheter 
Manufacturer: Sino Medical Sciences Technology Inc. 
 Control Device: 
Product Name: NSE Coronary Dilatation Catheter 
Manufacturer: Goodman Co., Ltd. 
Medical Device Registration Certificate No.: NMPA (I) 20163035067 
Estimation 
of 
Sample 
Size 
After literature review, according to the results of relevant literature and clinical 
experience of the scoring balloon catheter in the treatment of coronary artery disease, 
assuming that the SINOMED Coronary Scoring Balloon Catheter in the test group and 
Goodman NSE Coronary Dilatation Catheter in the control group can reach the equivalent 
level, and the device success rate (lesion level) is expected to reach 96%, with one-sided 
test α as 0.025, test power (1-β) as 0.8 and non-inferiority margin δ as -10%, the number 
of cases to be included in each group is 61 as calculated by PASS software. In 
consideration of a 10% dropout rate, this study requires 136 subjects, 68 each in test group 
and control group. 
Study 
Method 
This study is a prospective, multicenter, randomized, parallel controlled, non-inferiority 
design to evaluate the safety and effectiveness of Coronary Scoring Balloon Catheter. It 
is planned to recruit a total of 136 patients with coronary artery stenosis. After all subjects 
sign the ICF, the investigators will judge whether the subjects meet the patient-related 
inclusion criteria and do not meet the patient-related exclusion criteria. Then the subjects 
undergo coronary angiography, and if their imaging results meet the inclusion criteria 
and do not meet the exclusion criteria, they will be randomized to the test group or control 
group (the probability of being assigned to the test group or control group is 50%) for 
balloon dilation of lesions. The subjects in the test group use the Coronary Scoring 
Balloon Catheter developed by Sino Medical Sciences Technology Inc., and those in the 
control group use the NSE Coronary Dilatation Catheter (NMPA (I) 20163035067) 
developed by Goldman Co., Ltd. 
The visit time points during this trial include pre-PCI, during procedure, and follow-up 
from post-procedure to pre-discharge. In this study, the device success rate (lesion level) 
is the primary endpoint, and the secondary endpoints is the procedural success rate 
(subject level). At the same time, the incidences of target lesion failure (TLF) composite 
endpoint and its composite events, patient-oriented composite endpoint (PoCE) and its 
composite events, as well as other procedure-oriented adverse events (AEs), serious 
adverse events (SAEs) (such as balloon rupture, vascular dissection, in-stent thrombosis) 
and device defects from the beginning of procedure to pre-discharge are taken as the 
safety endpoints. 
Effectiveness 
Endpoints 
Primary efficacy endpoint: Device success rate (lesion level) 
To achieve device success (lesion level), the following conditions should be met 
simultaneously: 
a. The whole balloon dilatation procedure, including delivery, passing through the 
lesion, inflation and dilatation, deflation and retraction and withdrawal of the 
balloon, is successfully completed. 
b. ≤30% residual stenosis of target lesion immediately after PCI (For ISR and drug 
balloon-related restenosis, residual stenosis <50% post-procedure) 
Secondary efficacy endpoints: Procedural success rate (subject level) 
To achieve procedural success (subject level), the following conditions should be met 
simultaneously: 
a. ≤30% residual stenosis of at least one target lesion immediately after PCI (For ISR 

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and drug balloon-related restenosis, residual stenosis <50% post-procedure) 
b. No major adverse cardiac events (MACE) during post-procedure hospitalization: all-
cause death, myocardial infarction (MI) and target lesion revascularisation (TLR). 
Safety 
Endpoints 
(1) Incidence of target lesion failure (TLF) composite endpoint 
Any of the following events is considered as a TLF: 
a. 
Cardiac death (the death with uncertain cause is also considered cardiac death); 
b. Target vessel myocardial infarction (TV-MI); 
c. 
Clinically indicated target lesion revascularisation (CI-TLR). 
(2) Incidence of patient-oriented composite endpoint (PoCE) 
Any of the following events is considered as a PoCE: 
a. 
All-cause death; 
b. All myocardial infarction; 
c. 
All revascularisation events, including target lesion revascularisation (TLR), target 
vessel 
non-target-lesion 
revascularisation 
(TVR), 
and 
non-target 
vessel 
revascularisation. 
(3) Occurrence of single AE and SAE 
Other possible AEs such as balloon rupture, vessel perforation, dissection, acute 
occlusion, vasospasm, thrombosis (including in-stent thrombosis), arrhythmia requiring 
intervention. 
(4) Incidence of device defects 
Case 
Selection 
Inclusion criteria: 
1) Patients are at least 18 to 75 years of age, male or not pregnant female; 
2) Patients with asymptomatic ischemic evidence, stable or unstable angina pectoris or 
old myocardial infarction; 
3) In situ or restenotic lesion(s) in coronary arteries, including in-stent restenosis (ISR); 
4) Target lesion(s) must have a diameter of 2.0 mm ~ 3.5 mm and a length of ≤ 30 mm; 
5) Target lesion(s) must have a percent diameter stenosis of ≥70%% or ≥50% with 
evidence of ischemia; 
6) Patients have a planned intervention at no more than two lesions, in different target 
vessels; 
7) Investigators believe that target lesion atherosclerotic plaques require the scoring 
balloon treatment, in which the balloon can be passed through by pre-dilation. 
8) Able to understand the purpose of the trial, voluntarily participate and sign the ICF. 
Exclusion criteria: 
1) Evidence of ongoing acute myocardial infarction within a week. 
2) Chronic total occlusion (TIMI 0 pre-procedure), left main lesion, intervention-
required three-vessel lesions, and bypass lesion. 
3) Severe calcification and target lesion in a severe angulation (≥ 45 degrees). 
4) Patients with severe heart failure (NYHA Class III or above) or left ventricular 
ejection fraction <40% (ultrasound or left ventricular angiography). 
5) Patients with severe liver and renal dysfunction, as Cr >176.82 umol/L or Cr >2.0 
mg/dl. 
6) Patients with history of active digestive tract ulcer, history of cerebral hemorrhage 
or subarachnoid hemorrhage, history of ischemic stroke 6 months before procedure, 
as well as patients with bleeding tendency, antiplatelet preparation and anticoagulant 
therapy contraindications that cannot be treated with anticoagulant therapy. 
7) Patients with allergies to heparin and contrast agent. 
8) Target lesion demonstrating severe dissection prior to planned deployment of the 
study balloon. 
9) Visible thrombus at the target lesion. 
10) Patients to receive heart transplantation. 
11) Patients who participated in other clinical trials of drugs or medical devices, but did 
not reach the primary endpoint. 
12) Patients who are judged by the investigators to have poor compliance, are unable to 
complete the study as required, or are judged by the investigators to be unsuitable 
for participation in the study. 
13) Patients who are not suitable for coronary artery bypass grafting (CABG). 

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Schedule of Tests and Procedures Table 
Item 
Time points 
Screening period 
Treatment period 
Follow-up period 
Pre-procedure (-14d-
0d) 
Procedure details (0d) 
From post-procedure to 
pre-discharge 
Signing of ICF 
▲ 
 
 
Demographic data 
▲ 
 
 
Medical history 
▲ 
 
 
Vital signs1 
▲ 
▲ 
▲ 
Pregnancy test2 
▲ 
 
 
Blood routine and blood 
biochemistry3 
▲ 
 
▲ 
Myocardial 
enzyme 
spectrum4 
▲ 
 
▲(Within 48 hours 
post procedure) 
ECG5 
▲ 
 
▲(Within 48 hours 
post procedure) 
Inclusion/exclusion criteria 
▲ 
 
 
Center random 
▲ 
 
Clinical evaluation 
 
▲ 
 
Coronary angiography6 
 
▲ 
 
Coagulation functions7 
▲ 
 
 
Adverse 
cardiovascular 
event8 
 
▲ 
▲ 
AE and SAE 
 
▲ 
▲ 
Device defect 
 
▲ 
 
Cardiovascular 
concomitant medications 
▲ 
▲ 
▲ 
Notes: 
(1) Vital signs: Systolic blood pressure, diastolic blood pressure and heart rate. 
(2) Pregnancy test: Only applicable to women of childbearing potential. 
(3) In order to protect the rights and interests of subjects, the examination results of blood routine and 
blood biochemistry within one month before procedure (the recent results shall prevail for those who 
have undergone examinations for many times) will be accepted: ① Blood routine: white blood cell 
count (WBC), red blood cell count (RBC), platelet count (PLT) and hemoglobin (HB); ② Renal 
function: serum creatinine (SCr); ③ Liver function: alanine aminotransferase (ALT) and aspartate 
aminotransferase (AST); ④ Blood lipids: triglyceride (TG), total cholesterol (TC), high density 
lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C). 
(4) Myocardial enzyme spectrum: creatine kinase (CK), creatine kinase isoenzyme (CK-MB), cardiac 
troponin T (cTnT)/cardiac troponin I (cTnI) (choose one, not all are mandatory). Note: Post-
procedure myocardial enzyme spectrum should be completed within 48 hours after procedure, and 
should be reexamined before discharge if the results are abnormal and clinically significant. 
(5) Post-procedure ECG should be done within 48 hours after procedure. 
(6) Coronary angiography is completed immediately after procedure and made into CD in each site. 
(7) Coagulation functions: Prothrombin time (PT), activated partial thromboplastin time (APTT), 
thrombin time (TT), fibrinogen (FIB). In order to protect the rights and interests of subjects, the 
examination results within one month before procedure will be accepted. 
(8) Adverse cardiovascular event includes major adverse cardiac events (MACE: including all-cause 
death, myocardial infarction [MI], and target lesion revascularisation [TLR]), target lesion failure 
(TLF, including cardiac death, target vessel myocardial infarction [TV-MI], and clinically indicated 
target lesion revascularisation [CI-TLR]), patient-oriented composite endpoint (PoCE, including all-
cause death, all MIs, and all revascularisation events (target lesion revascularisation [TLR], target 
vessel non-target-lesion revascularisation [TVR] and non-target vessel revascularisation), etc. 
 
 

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List of Abbreviations 
Abbreviation 
Complete spelling 
%DS 
percent diameter stenosis 
ALT 
Alanine Aminotransferase 
AST 
Aspartate Aminotransferase 
APTT 
Activated Partial Thromboplastin Time 
CABG 
coronary artery bypass grafting 
CAD 
coronary artery disease 
CI-TLR 
clinical indicated target lesion revascularisation 
CK 
creatine kinase 
CK-MB 
creatine kinase-myocardial band 
cTnI 
Cardiac troponin I 
cTnT 
Cardiac troponin T 
FIB 
Fibrinogen 
HDL-C 
High density lipoprotein cholesterol 
ISR 
in-stent restenosis 
LDL-C 
Low density lipoprotein cholesterol 
MACE 
major adverse cardiovascular events 
MI 
myocardial infarction 
PCI 
percutaneous coronary intervention 
PoCE 
patient-oriented composite endpoint 
PT 
prothrombin time 
PTCA 
percutaneous transluminal coronary angioplasty 
RVD 
reference vessel diameter 
SCr 
Serum creatinine 
TC 
Total cholesterol 
TG 
Triglyceride 
TIMI 
Thrombolysis In Myocardial Infarction 
TLF 
target lesion failure 
TLR 
target lesion revascularisation 
TV-MI 
target vessel myocardial infarction 
TVR 
target vessel revascularisation 
TT 
Thrombin Time 
 
 

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Text of Study Protocol 
1. Sponsor Information 
1.1 Name of Sponsor 
Sino Medical Sciences Technology Inc. 
1.2 Address of Sponsor 
F2, Building B, TEDA Bio-pharmaceutical, No. 5 The Fourth Avenue, Tianjin 
Economic-Technological Development Area 
1.3 Contact Information of Sponsor 
Contact Person: Yu Xiaoyan 
Tel.: 18614030565 
E-mail: yuxiaoyan@sinomed.com 
2. Information on Study Sites and Principal Investigators 
The list of study sites and principal investigators (PIs) is present in Appendix 1. 
During the clinical study, if the existing participating sites fail to obtain the 
approval of the clinical trial management department or the EC, resulting in the 
progress of the study significantly slower than the expected schedule, the sponsor 
should fully communicate and discuss with the coordinating investigator, and 
then make adjustments to the participating sites (abandonment or addition), and 
may file the list of clinical study sites in the Appendix without amending the text 
of the protocol. The final list of participating sites should be submitted to the 
clinical trial management departments and ECs of all participating sites for filling. 
3. Background Information of Clinical Trial 
3.1 R&D Background 
Since the success of the first percutaneous transluminal coronary angioplasty 
(PTCA) on September 16, 1977, with the continuous iteration and improvement 
of angioplasty techniques, PTCA has now become the most basic method of 
percutaneous coronary intervention (PCI), which is of great value for application 
to coronary artery disease (CAD). 
The principle of PTCA is that the mechanical extrusion of vessel wall by balloon 
causes the atherosclerotic plaque to rupture irregularly, thus dilating the narrow 
lumen [1]. However, some lesions, especially coronary artery calcification or 
dense fibrosis, are extremely difficult to be properly dilated with traditional 
balloons, which is often related to the failure of stent delivery or insufficient stent 
dilation. When the stent is placed at the poorly dilated lesions, it is very likely to 
lead to stent malapposition, incomplete expansion and poor symmetry, resulting 

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Page 10 of 48 
in a significant increase in periprocedural complications and an increase in risks 
of in-stent thrombosis and restenosis [2]. Because of the stent incomplete 
expansion, even post-dilation, the effect is also poor, thus leading to an increase 
in the incidence of adverse events such as in-stent thrombosis [3]. In recent years, 
some functional balloons, such as scoring balloons, have obviously improved the 
effect of complex coronary pre-dilation, greatly improving the acute procedural 
success rate and long-term prognosis. 
Functional balloons are designed to combine their surface with a rigid metal or 
plastic element to enhance the interaction between the balloon surface and the 
plaque underneath. This improved interaction has two main advantages: the 
creation of a controlled plaque detachment that is not easily spread, and in 
addition, a reduction in longitudinal displacement or balloon slippage during 
dilation. Functional balloons currently on the market include cutting balloons 
with rigid microblades parallel to the longitudinal axis on the balloon surface, 
AngioSculpt balloons with Ni-Ti alloy wound along the balloon surface in a spiral 
shape on the longitudinal axis, and scoring balloons with nylon elements wound 
along the balloon surface parallel to the longitudinal axis. Compared with 
common balloons, functional balloons have shown certain advantages in the 
clinical application for the treatment of ISR, coronary ostial lesions, bifurcation 
lesions, small vessel lesions, and calcified lesions [4]. 
However, cutting balloons (such as Scoreflex) have a potential "relaxation" 
phenomenon in design and cannot produce multiple cutting effects [5]. At the same 
time, for cutting balloons, their inflexibility in clinical settings, difficulty in 
delivery, and poor passage at lesions (due to their high cross profile: 0.041–
0.046
〃) lead to a higher incidence of intra-procedural perforation [6]. It is 
particularly important to optimize the flexibility and other processes of existing 
functional balloons and reduce the risk of complications such as intra-procedural 
vessel perforation and damage to normal vessel walls, so as to benefit the large 
population of coronary artery disease, especially those PCI patients with calcified 
lesions. 
A new generation of the scoring balloon catheter (Coronary Scoring Balloon 
Catheter) independently developed by Sino Medical Sciences Technology Inc. 
(hereinafter referred to as SINOMED) has undergone the type test at Tianjin 
Medical Devices Quality Supervision and Testing Center of the NMPA, and has 
been granted the test qualification report; meanwhile, Coronary Scoring Balloon 
Catheter has undergone the animal experimental study, verifying its safety. This 
study is intended to evaluate the safety and effectiveness of the new generation 
scoring balloon catheter (Coronary Scoring Balloon Catheter) developed and 
manufactured by SINOMED for human use, so as to provide the basis for its 
eventual formal marketing and application in China. 
3.2 Basic Information of Product 

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(1) 
Product Characteristics 
The Coronary Scoring Balloon Catheter has the following characteristics: (1) the 
scoring element made of Ni-Ti alloy with shape memory can restore its original 
shape, which is conducive to the safe withdrawal of the product from the blood 
vessel; (2) the spiral winding scoring element can act on the lesion at 360°, with 
a wide range of action; (3) the trapezoidal scoring similar to a triangle is 
conducive to the scoring element embedded in the plaque. 
(2) 
Structural Composition and Operating Principle 
1) 
Device Composition 
The balloon catheter consists of TIP, balloon protective sheath, balloon, scoring 
element, balloon inner tube, Marker, balloon outer tube, metal catheter, sleeve, 
connector, opening, and two markers of metal catheter. The product structure 
diagram is shown in Figure 1: 
 
Figure 1 Structure diagram of Coronary Scoring Balloon Catheter 
1) TIP 
2) Balloon protective sheath 
3) Balloon 
4) Balloon inner tube 
5) Marker [Two Markers are placed on the balloon inner tube (7), with their 
outer edges flush with the balloon neck] 
6) Distal outer tube 
7) Metal catheter (hypotube) 
8) Sleeve 
9) Connector 
10) Opening (guidewire exit port) 
11) Two markers of metal catheter 
12) Proximal outer tube 
13) Distal retainer 
14) Scoring element 
D Balloon Diameter 
L2 Balloon Effective Length 

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15) Proximal retainer 
Note 1: D indicates the diameter of balloon post-dilation. 
Note 2: L2 indicates the balloon effective length on the balloon catheter. 
Note 3: L1 indicates the effective length of the balloon catheter. 
Note 4: The complete Coronary Scoring Balloon Catheter is put into a protective 
sheath 
The two developing points located on the balloon inner tube can accurately mark 
the position of the balloon under X-ray, which is helpful for checking the length 
of balloon dilated. The Ni-Ti alloy scoring element is spirally wound on the 
balloon, which is only attached to the balloon catheter at the distal and proximal 
ends, reducing the likelihood of slippage during balloon dilation. There are two 
markers (93 cm and 103 cm away from the distal end of the catheter, respectively) 
at the proximal end of the catheter, which are used to determine the position of 
the dilatation catheter relative to the front end of the guiding catheter in femoral 
artery puncture or brachial puncture. The guidewire exit port located at the front 
end of the catheter is about 24 cm away from the distal end. The Coronary Scoring 
Balloon Catheter can be used in combination with a guiding catheter with a 
minimum inner diameter of 1.68 mm (6Fr/0.066 inch); all the products can be 
used in combination with a guidewire with a maximum outer diameter of 0.36 
mm (0.014 inch). 
2) 
Operating Principle 
The Coronary Scoring Balloon Catheter is a rapid exchange scoring balloon 
catheter. In interventional procedure, the Coronary Scoring Balloon Catheter is 
punctured percutaneously and travels along the blood vessel to the lesion site. 
The scoring element wound on the balloon in a spiral way can reduce the slippage 
of the balloon during dilation. 
3.3 Intended Use and Related Information 
(1) 
Intended Use (Indications, Intended Population, Application Site) 
The Coronary Scoring Balloon Catheter is intended for the treatment of coronary 
artery stenosis, including in-stent restenosis (ISR) and complex type C lesions, to 
improve myocardial perfusion. 
(2) 
Use Conditions and Method 
This study product is intended for lesion localization and dilation under coronary 
angiography conditions and cannot be reused. The use method and steps of the 
product include pre-use inspection, unpacking, pre-procedure preparation, 
balloon catheter preparation, balloon catheter placement, balloon dilation process 
and balloon catheter withdrawal process. See the instructions for use (IFU) for 
details. 

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(3) 
Contraindications 
 All contraindications to angioplasty are contraindications to this product; 
 Coronary artery spasm without organic stenosis; 
 Left main lesion without bypass grafting or collateral circulation protection; 
 Bifurcated lesions covered by stents; 
 Stent fracture lesions; 
 Patients with allergic reaction to the contrast agent; 
 Patients with obvious abnormal coagulation function or hemorrhagic 
tendency; 
 Patients who are contraindicated for antiplatelet or anticoagulant therapy; 
 Other lesions that are not conducive to balloon dilation; 
 Patients with severe infection or organ dysfunction; 
 Patients who are not suitable for coronary artery bypass grafting (CABG); 
 Except for the above matters, patients diagnosed by physicians as unsuitable 
for the use of relevant medical devices.  
(4) 
Warnings 
 Please read the IFU carefully prior to use. Please pay special attention to all 
warnings and precautions so as to avoid accidents. 
 Please carefully select the patients with indications. Using this product has 
the same risks as the general angioplasty, including acute vascular occlusion, 
acute and sub-acute thrombosis, vascular dissection, vascular hemorrhage, 
etc. 
 The Coronary Scoring Balloon Catheter has been sterilized before release 
from the factory, and it is sterile, non-pyrogenic, and intended for single-use 
only. Re-use, re-processing or re-sterilization may result in product structure 
deformation, failure and contamination, and may cause patient infection or 
cross infection, and evenly patient injury, illness or death. 
 The procedure shall be performed by qualified professionals who have 
received professional training in coronary angioplasty, and the product 
should be used in the clean interventional operating room of a hospital. 
 Check the product packaging carefully before use. If the carton package is 
opened, damaged, or the primary packaging is broken, Do Not use the 
product. 
 Before use, please pay attention to the shelf life of the product and do not use 
an expired product. 

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 Intravascular procedures should be performed under high-resolution X-ray 
fluoroscopy, and if resistances encounter or abnormalities occur, please 
terminate the procedure immediately and confirm the cause. 
 When using multiple devices in the body, Do Not let the Coronary Scoring 
Balloon Catheter wind with other devices. If resistances encounter or 
abnormalities occur, please terminate the procedure immediately and confirm 
the cause. 
 To prevent vascular injury, the inflated diameter of the balloon should be 
similar to the diameter of the coronary artery at the proximal or distal 
stenosis. When using this product, pre-dilate the lesion appropriately 
according to its characteristics. 
 Caution should be exercised when dealing with distal lesions with newly 
implanted drug-eluting stents (drug-eluting stents may delay intimal repair). 
 The maximum inflation pressure of the balloon cannot exceed the labeled 
rated burst pressure (RBP). 
 This product is not intended for power injection. 
 In the process of a procedure, patients should be given appropriate 
anticoagulants and vasodilators. 
4. Study Objective 
To evaluate the safety and effectiveness of Coronary Scoring Balloon Catheter 
manufactured by Sino Medical Sciences Technology Inc. in the treatment of 
coronary artery stenosis. 
5. Study Design 
5.1 Overall Design and Its Determination Basis 
This clinical trial is a prospective, multicenter, randomized, parallel controlled, 
non-inferiority design. 
Multicenter clinical trial: refers to the clinical study conducted in two (inclusive) 
or more medical device clinical trial institutions under the same clinical trial 
protocol. 
Parallel controlled design: Based on the Guidance for the Design of Medical 
Device Clinical Trials, the controlled clinical trial is conducted using the 
marketed devices with recognized efficacy/safety. The Coronary Scoring Balloon 
Catheter is a class Ⅲ medical device, and there are few similar products on the 
market. In order to evaluate the effectiveness and safety of Coronary Scoring 
Balloon Catheter, the NSE Coronary Dilatation Catheter (NMPA (I) 
20163035067), which is similar in structure and operating principle, relatively 
widely used in clinical practice and has positive efficacy in China and abroad, is 

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selected as the control device after investigation. 
Randomization: Randomization is the basic principle to be followed by parallel 
controlled clinical trials. Each subject in a clinical trial has the same opportunity 
(the ratio of cases in test group to control group is 1:1) to be assigned to test group 
or control group, without affection of subjective wishes of the investigator and/or 
subject, to ensure the subjects in test group and control group comparable in 
various known and unknown baseline variables that may affect the trial result. 
Blinding: Due to the different inherent characteristics (appearance, marking, etc.) 
of the investigational medical device and the control device, the subjects and 
investigators cannot be blinded in the trial, so an open-label design is adopted. 
Non-inferiority test: The non-inferiority test is selected to confirm the 
efficacy/safety of the investigational medical device, which if lower than that of 
the control device but the difference between them is less than the pre-set non-
inferiority margin, the difference is clinically acceptable. 
5.2 Subject Enrollment 
5.2.1 Inclusion Criteria 
(1) Patients are at least 18 to 75 years of age, male or not pregnant female; 
(2) Patients with asymptomatic ischemic evidence, stable or unstable angina 
pectoris or old myocardial infarction; 
(3) In situ or restenotic lesion(s) in coronary arteries, including in-stent 
restenosis (ISR); 
(4) Target lesion(s) must have a diameter of 2.0 mm ~ 3.5 mm and a length of ≤ 
30 mm; 
(5) Target lesion(s) must have a percent diameter stenosis of ≥70%% or ≥50% 
with evidence of ischemia; 
(6) Patients have a planned intervention at no more than two lesions, in different 
target vessels; 
(7) Investigators believe that target lesion atherosclerotic plaques require the 
scoring balloon treatment, in which the balloon can be passed through by 
pre-dilation. 
(8) Able to understand the purpose of the trial, voluntarily participate and sign 
the ICF. 
5.2.2 Exclusion Criteria 
(1) Evidence of ongoing acute myocardial infarction within a week. 
(2) Chronic total occlusion (TIMI 0 pre-procedure), left main lesion, 
intervention-required three-vessel lesions, and bypass lesion. 

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(3) Severe calcification and target lesion in a severe angulation (≥ 45 degrees). 
(4) Patients with severe heart failure (NYHA Class III or above) or left 
ventricular ejection fraction <40% (ultrasound or left ventricular 
angiography). 
(5) Patients with severe liver and renal dysfunction, as Cr >176.82 umol/L or 
Cr >2.0 mg/dl. 
(6) Patients with history of active digestive tract ulcer, history of cerebral 
hemorrhage or subarachnoid hemorrhage, history of ischemic stroke 6 
months before procedure, as well as patients with bleeding tendency, 
antiplatelet preparation and anticoagulant therapy contraindications that 
cannot be treated with anticoagulant therapy. 
(7) Patients with allergies to heparin and contrast agent. 
(8) Target lesion demonstrating severe dissection prior to planned deployment 
of the study balloon. 
(9) Visible thrombus at the target lesion. 
(10) Patients to receive heart transplantation. 
(11) Patients who participated in other clinical trials of drugs or medical devices, 
but did not reach the primary endpoint. 
(12) Patients who are judged by the investigators to have poor compliance, are 
unable to complete the study as required, or are judged by the investigators 
to be unsuitable for participation in the study. 
(13) Patients who are not suitable for coronary artery bypass grafting (CABG). 
5.2.3 Criteria and Procedures for Subject Withdrawal 
Subjects who have signed the ICF and have been screened and enrolled into the 
trial but withdraw before the end of the observation period as required by the 
protocol, regardless when and why they withdraw, should be deemed as dropout 
cases. 
(1) Withdrawal at the investigator's discretion 
1) Those who experience SAEs that, in the judgment of the investigators, warrant 
discontinuation of the trial. 
2) During the trial, the subjects suffer from complications and special 
physiological changes, and thus are not suitable to continue the trial. 
3) Poor compliance of subjects. 
(2) Self-withdrawal of subjects 
1) Subjects who, for whatever reason, are unwilling or unable to continue the 
clinical trial, propose withdrawal from the trial to the investigators and 

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terminate the trial. 
2) Subjects who are lost to follow-up since they refuse the further treatment and 
follow-up despite not specifically proposing withdrawal from the trial. 
(3) Management of drop-out 
1) All drop-out subjects should be recorded in the original medical records with 
study conclusions and reasons for drop-out. 
2) After the subjects are dropped out, the investigators should communicate with 
the subjects as much as possible, ask them the reasons for drop-out, and make 
the evaluation items as complete as possible. 
3) In the event of withdrawal, the investigators should take appropriate treatment 
measures for alternative therapy according to the subjects’ actual conditions. 
5.2.4 Criteria and Procedures for Discontinuation or Termination of the 
Trial 
(1) Criteria for Discontinuation or Termination of the Trial 
Discontinuation of the trial means that the clinical trial has not been completed as 
per its protocol, but discontinued prematurely. Discontinuation of the trial is to 
protect the rights and interests of subjects, ensure the quality of the trial and avoid 
unnecessary economic losses. Criteria for Discontinuation of the Trial: 
1) If serious safety issues occur during the trial, the trial should be discontinued 
immediately. 
2) Major defects are found in the clinical trial protocol during the trial, making 
it difficult to evaluate the effect of the investigational medical device; Or 
although there are no obvious defects in the trial protocol, significant 
deviations occur during implementation, making it difficult to evaluate the 
effectiveness and safety of the investigational medical device if continued. 
3) The sponsor requests the discontinuation of the trial for funding reasons, 
management reasons, etc.; 
4) The EC finds that the rights and interests of subjects cannot be guaranteed and 
asks for the discontinuation of the trial. 
5) The medical products regulatory authority orders the discontinuation of the 
trial for some reasons. 
(2) Procedures for Discontinuation or Termination of the Trial 
The sponsor, if decides to discontinue or terminate the clinical trial, should report 
to all management departments of the medical device clinical trial institutions, 
ECs and PIs, and report to the medical products regulatory authority of the 
province, autonomous region or municipality directly under the central 
government where the sponsor is located, report to the medical products 

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regulatory authorities and health administrations of the provinces, autonomous 
regions or municipalities directly under the central government where the medical 
device clinical trial institutions are located within the time specified in the Good 
Clinical Practice for Medical Devices ([2022] Announcement No. 28). If the 
medical products regulatory authority or the EC requests suspension or 
termination of the trial, the trial shall be suspended or terminated within the 
prescribed time limit. When suspended or terminated, the trial is ended only after 
the enrolled subjects have completed the treatment and the post-treatment visits 
have been made according to the protocol, ensuring that the subjects receive 
appropriate treatment and follow-up. 
5.3 Evaluation Methods 
5.3.1 Effectiveness Evaluation 
(1) 
Description on Effectiveness Endpoint 
1) Primary efficacy endpoint: Device success rate (lesion level) 
To achieve device success (lesion level), the following conditions should be met 
simultaneously: 
a. The whole balloon dilatation procedure, including delivery, passing through 
the lesion, inflation and dilatation, deflation and retraction and withdrawal of 
the balloon, is successfully completed. 
b. ≤30% residual stenosis of target lesion immediately after PCI (For ISR and 
drug balloon-related restenosis, residual stenosis <50% post-procedure) 
2) Secondary efficacy endpoints: Procedural success rate (subject level) 
To achieve procedural success (subject level), the following conditions should be 
met simultaneously: 
a. ≤30% residual stenosis of at least one target lesion immediately after PCI (For 
ISR and drug balloon-related restenosis, residual stenosis <50% post-
procedure) 
b. No major adverse cardiac events (MACE) during post-procedure 
hospitalization: all-cause death, myocardial infarction (MI) and target lesion 
revascularisation (TLR). 
(2) 
Basis for Determination 
PTCA technique is relatively mature in clinical application. In its clinical studies 
published, especially pre-marketing registry studies, the use effect of PTCA in 
coronary artery in situ lesions or restenosis lesions (including ISR) is evaluated 
at the same time, with device success rate and procedural success rate as the 
endpoints. Regarding the definition of device success rate, on the one hand, it 
focuses on the successful use of the product itself, for example, the FDA-
registered clinical trials such as Scoreflex NC PTCA Scoring Catheter (P200041) 

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[7] and Lacrosse PTCA Scoring Catheter (NCT04985773) [8], and the study of 
Auer et al. [9] defined the device success rate as the smooth delivery, inflation and 
dilation, deflation and retraction and withdrawal of the product throughout the 
balloon dilation procedure; on the other hand, it focuses on the immediate post-
procedure residual stenosis following completion of the procedure, for example, 
the FDA-registered clinical trials such as Scoreflex NC PTCA Scoring Catheter 
(P200041) [7], Lacrosse PTCA Scoring Catheter (NCT04985773) [8] and 
AngioSculpt PTCA Scoring Catheter (P050018) [10] reported the device success 
rate as that at least one target lesion has achieved < 50% residual stenosis 
immediately after procedure and no MACE-related events occur during post-
procedure hospitalization, which is also a criterion to be met as defined in the 
procedural success rate. At the same time, the provisions for residual stenosis 
after PCI in relevant clinical studies and clinical practice are taken into account, 
for example, the studies such as by Auer et al. [9] defined the balloon procedure 
success as residual stenosis of lesion < 30%, and the studies such as by Lee SH 
et al. [11] defined the procedural success as at least residual stenosis of < 30% post-
procedure, and freedom of major AEs (death, MI, or emergency coronary artery 
bypass grafting) during post-procedure hospitalization. 
In summary, referring to clinical study design literature of similar PTCA balloons 
in China and at abroad, the PIs decide that the device success rate (lesion level) 
is set as the primary efficacy endpoint, and the procedural success rate is set as 
the secondary efficacy endpoints in combination with the indications for use of 
the test devices and the previous clinical procedure experience of the 
investigators. 
5.3.2 Safety Evaluation 
(1) 
Description on Safety Evaluation Endpoints 
1) Incidence of target lesion failure (TLF) composite endpoint 
Any of the following events is considered as a TLF: 
a. Cardiac death (the death with uncertain cause is also considered cardiac 
death); 
b. Target vessel myocardial infarction (TV-MI); 
c. Clinically indicated target lesion revascularisation (CI-TLR). 
Evaluation method: The observation time range is from the start of procedure to 
pre-discharge. The incidences of single and composite events are counted, 
respectively, by lesions. 
2) Incidence of patient-oriented composite endpoint (PoCE) 
Any of the following events is considered as a PoCE: 
a. All-cause death; 

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b. All myocardial infarction; 
c. All revascularisation events, including target lesion revascularisation (TLR), 
target vessel non-target-lesion revascularisation (TVR), and non-target vessel 
revascularisation. 
Evaluation method: The observation time range is from the start of procedure to 
pre-discharge. The incidences of single and composite events are counted, 
respectively, by subjects. 
3) Occurrence of single AE and SAE 
Evaluation method: The observation time range is from the start of procedure to 
pre-discharge. Other possible AEs such as balloon rupture, vessel perforation, 
dissection, acute occlusion, vasospasm, thrombosis (including in-stent 
thrombosis), arrhythmia requiring intervention. The incidences of single events 
are counted, respectively. 
4) Incidence of Device Defects 
(2) 
Basis for Determination 
By referring to study design literature on PTCA balloons with equivalent 
functions and similar structures in China and at abroad, the target lesion failure 
(TLF) composite endpoint and patient-oriented composite endpoint (PoCE) are 
set as the primary safety endpoints based on the decision of the PIs, taking into 
account the safety endpoints of relevant interventional procedures and clinical 
experience of the investigators, and the definitions of guidelines such as 
AHA/ACC [12] and ARC-2 [13] are used to more comprehensively and fully 
evaluate the safety of the study product. 
5.4 Investigational Medical Device and Control Device 
(1) Investigational Medical Device 
Product Name 
Coronary Scoring Balloon Catheter 
Manufacturer 
Sino Medical Sciences Technology Inc. 
Model/specification 2.0-3.5 mm in diameter, 10-15 mm in length (see Table 1) 
Table 1 Model/specification of investigational Medical device 
Diameter 
(mm) 
Length (mm) 
10 
15 
2.00 
● 
● 
2.50 
● 
● 
2.75 
● 
● 
3.00 
● 
● 
3.50 
● 
● 
Table 2 Relationship between balloon diameter and inflation pressure 

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Balloon 
diameter/m
m 
Pressure/atm 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
2.00 
1.90 
1.95 
2.00 
2.05 
2.08 
2.12 
2.15 
2.17 
2.19 
2.21 
2.22 
2.50 
2.42 
2.49 
2.50 
2.60 
2.64 
2.68 
2.72 
2.75 
2.78 
2.80 
2.84 
2.75 
2.62 
2.70 
2.75 
2.82 
2.87 
2.90 
2.93 
2.96 
2.99 
3.03 
3.05 
3.00 
2.85 
2.93 
3.00 
3.06 
3.11 
3.17 
3.21 
3.26 
3.31 
3.36 
3.41 
3.50 
3.29 
3.39 
3.50 
3.56 
3.61 
3.66 
3.71 
3.75 
3.79 
3.83 
3.87 
 
 
Nominal balloon pressure 
Rated burst pressure of balloon 
*The rated burst pressure of balloon is obtained according to the test results of in vitro tests. At least 99.9% 
of balloons will not burst at the rated burst pressure or below (95%CI). During the balloon inflation, it is 
recommended that a pressure detection device should be used to prevent the excessive inflation of the 
balloon. The size of actual dilation in vivo should be determined by angiography. 
(2) 
Control Device 
Product Name 
NSE Coronary Dilatation Catheter 
Manufacturer 
Goodman Co., Ltd. 
Medical Device Registration 
Certificate No. 
NMPA (I) 20163035067 
Model/specification 
2.0-4.0 mm in diameter and 13 mm in length (see 
Table 3) 
Table 3 Model/specification of control device 
Specification 
Balloon diameter (mm) 
Length (mm) 
NS20013 
2.00 
13 
NS22513 
2.25 
13 
NS25013 
2.50 
13 
NS27513 
2.75 
13 
NS30013 
3.00 
13 
NS32513 
3.25 
13 
NS35013 
3.50 
13 
NS37513 
3.75 
13 
NS40013 
4.00 
13 
Table 4 Relationship between balloon diameter and inflation pressure 
Balloon diameter/mm 
Pressure/atm 
4 
6 
8 
10 
12 
14 
2.00 
1.93 
2.00 
2.06 
2.10 
2.14 
2.18 
2.25 
2.16 
2.25 
2.31 
2.36 
2.40 
2.45 
2.50 
2.38 
2.50 
2.59 
2.66 
2.70 
2.74 
2.75 
2.65 
2.75 
2.81 
2.86 
2.90 
2.94 
3.00 
2.89 
3.00 
3.07 
3.12 
3.16 
3.20 
3.25 
3.13 
3.25 
3.32 
3.38 
3.43 
3.48 
3.50 
3.37 
3.50 
3.57 
3.64 
3.69 
3.73 

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3.75 
3.61 
3.75 
3.85 
3.91 
3.96 
4.00 
4.00 
3.86 
4.00 
4.10 
4.17 
4.22 
4.26 
 
5.5 Study Process 
5.5.1 Study Flowchart 
 
Note: * According to pre- and post-procedure conditions of the target lesion for the study balloon, pre-
dilation of common balloon and stent implantation or post-dilation balloon can be selected for further 
treatment. 
5.5.2 Conduct of Clinical Trial 
(1) Screening Assessment (-14 d to 0 d) 
Before the trial, all patients planning to be enrolled in this study must pass the 
screening assessment after voluntarily signing the ICF by themselves or their 
legally acceptable representatives. The following items shall be tested and 
evaluated before procedure: 
1) Collection of demographic data (age, gender, BMI), clinical diagnosis, and 
comorbidities of patients. 
2) Pregnancy test and blood/urine HCG test for women of childbearing potential 
when necessary; 
3) Pre-procedure examination of vital signs (systolic blood pressure, diastolic 
blood pressure and heart rate); 
4) Pre-procedure examination or review of blood routine, blood biochemistry 
and coagulation function test results within one month before procedure (the 
recent results shall prevail for those who have undergone examinations for 
many times): ① Blood routine: white blood cell count (WBC), red blood cell 
count (RBC), platelet count (PLT) and hemoglobin (HB); ② Renal function: 
serum creatinine (SCr); ③ Liver function: alanine aminotransferase (ALT) 
and aspartate aminotransferase (AST); ④ Blood lipids: triglyceride (TG), 
Nominal pressure 
(NP) 
Rated burst pressure (RBP)* 
Patients with coronary artery stenosis 
Sign the ICF and screen successfully based on enrollment criteria 
Log into the electronic system to obtain the grouping result 
Perform the procedure with investigational 
medical device 
Perform the procedure with control device 
Follow-up for the study balloon immediately post-procedure* 
Follow-up before discharge 
Record and report AE/SAE 

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total cholesterol (TC), high density lipoprotein cholesterol (HDL-C) and low 
density lipoprotein cholesterol (LDL-C); ⑤ Prothrombin time (PT), activated 
partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen 
(FIB). 
5) Pre-procedure examination of myocardial enzyme spectrum: creatine kinase 
(CK), 
creatine kinase 
isoenzyme 
(CK-MB), 
cardiac 
troponin 
T 
(cTnT)/cardiac troponin I (cTnI) (choose one, not all are mandatory) 
6) Pre-procedure examination of 12-lead ECG; 
7) Verification of inclusion and exclusion criteria. 
(2) Procedure details (0d) 
According to the routine procedure of the hospital, no special operation 
requirements are added. During this period, the following visit contents need to 
be completed: 
1) Vital signs (systolic blood pressure, diastolic blood pressure and heart rate); 
2) Coronary angiography (patient's lesions, residual stenosis after PCI, etc.); 
3) Clinical evaluation (study balloon operation, including balloon pushability, 
passing ability, withdrawal ability, dilation frequency, dilation pressure, etc.; 
device defects; balloon and stent usage); 
4) AEs (such as procedure-related complications, including puncture hematoma, 
vascular dissection, vessel perforation, acute occlusion, etc.); 
5) Cardiovascular adverse events (including major adverse cardiac events - 
MACE, target lesion failure - TLF, patient-oriented composite endpoint - 
PoCE); 
6) Cardiovascular concomitant medications (anticoagulants, antiplatelets, and 
statins). 
(3) Follow-up period (from post-procedure to pre-discharge) 
1) Vital signs (systolic blood pressure, diastolic blood pressure and heart rate); 
2) Post-procedure reexamination of blood routine and blood biochemistry: ① 
Blood routine: white blood cell count (WBC), red blood cell count (RBC), 
platelet count (PLT) and hemoglobin (HB); ② Renal function: serum 
creatinine (SCr); ③ Liver function: alanine aminotransferase (ALT) and 
aspartate aminotransferase (AST); ④ Blood lipids: triglyceride (TG), total 
cholesterol (TC), high density lipoprotein cholesterol (HDL-C) and low 
density lipoprotein cholesterol (LDL-C); 
3) Myocardial enzyme test 48 hours post-procedure. If the results are abnormal 
and clinically significant, re-examination should be performed before 

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discharge (the highest test value is recorded for those with multiple 
examinations); 
4) 12-lead ECG examination 48 hours post-procedure. 
5) AEs (such as procedure-related complications, including puncture hematoma, 
vascular dissection, vessel perforation, acute occlusion, etc.); 
6) Cardiovascular adverse events (including major adverse cardiac events - 
MACE, target lesion failure - TLF, patient-oriented composite endpoint - 
PoCE); 
7) Cardiovascular concomitant medications (anticoagulants, antiplatelets, and 
statins). 
5.5.3 Norms for Using Device 
Before using the test devices, the investigators should carefully read the relevant 
product IFU or materials and perform the procedures in strict accordance with 
IFU. (The following are recommended operations, and the operator may make 
slight modification according to the actual situations) 
 The diameter, length, and number of balloons are selected, and the dilation 
pressure is determined by the operator according to the lesion condition. 
 In use, the balloon should be dilated according to the nominal pressure 
specified in the IFU. A pressure monitoring device is recommended during 
the procedure to prevent excessive pressure. 
 According to pre- and post-procedure conditions of the target lesion for the 
study balloon, pre-dilation of common balloon and stent implantation or post-
dilation balloon can be selected for further treatment. 
 Patients have a planned intervention at no more than two lesions, in different 
target vessels. 
 When treated at the same time, the target and non-target lesions must be 
located in different vascular branches. 
 If the target lesion and non-target lesion are treated at the same time, the target 
lesion can only be treated after the non-target lesion has been treated 
successfully. 
 If a study balloon fails to dilate the target lesion, the operator will decide the 
follow-up treatment measures according to the lesion condition. 
 In the event of a flow-limiting dissection or rupture during dilation, the 
operator will decide what treatment measures will be taken. 
5.5.4 Specifications for Concomitant Therapy (e.g., Medication) 
Based on interventional guidelines in China and at abroad, dual antiplatelet 

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therapy is recommended to minimize the risk of thrombosis. The initial oral 
loading dose for all patients without contraindications to aspirin is 100~300 mg, 
which will be maintained for a long time at 100 mg/d. A P2Y12 receptor 
antagonist is added in addition to aspirin and maintained for at least 12 months, 
unless there are contraindications (e.g. higher risk of hemorrhage). Options 
include: 
 Ticagrelor: Loading dose of 180 mg, maintenance dose of 90 mg, bid; 
 Clopidogrel: loading dose of 300~600 mg, maintenance dose of 75mg, 
qd. 
Investigators can make decisions on the use of dual-antiplatelet drugs in patients 
according to clinical conditions, including whether pre-procedure loading dose is 
required. 
Low-density lipoprotein control with an optimal lipid-lowering regimen is 
recommended, with an LDL target of ≤ 1.8 mmol/L (≤ 70 mg/dL), moderate-
intensity statins recommended, and a combination with non-statins recommended 
if the OPC is not reached. 
5.6 Measures to Control Bias 
(1) In terms of trial design, the randomized, parallel-controlled clinical trial 
design is used, which can make the distribution of clinical trial influencing 
factors between the test group and control group tend to be balanced, 
reducing the selection bias and implementation bias. The objective 
judgment endpoints are adopted to avoid measurement bias. 
(2) In terms of trial implementation, the investigators in various sites use the 
same methods, follow the same standard operating procedures (SOPs), and 
receive uniform trainings before the trial to reduce observer bias. Subjects 
will be screened in strict accordance with the inclusion and exclusion criteria 
in the clinical trial protocol to reduce selection bias. The clinical research 
associate (CRA) appointed by the Sponsor shall regularly conduct 
monitoring on the study sites, making sure that all contents in the trial 
protocol are strictly followed. The raw materials are inspected to ensure 
consistent contents with the Case Report Form (CRF). 
(3) In terms of independent imaging evaluation, the addition of independent 
imaging analysis is not excluded in this trial. 
(4) To minimize bias, blinded data review may be considered. For possible 
confounding bias, appropriate control may be considered in the data analysis 
phase. 
6. Statistical Considerations 
6.1 Estimation of Sample Size 

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6.1.1 Overall Sample Size 
After literature review, according to the results of relevant study literature and 
clinical experience of the scoring balloon catheter in the treatment of coronary 
artery disease, assuming that the SINOMED Coronary Scoring Balloon Catheter 
in the test group and Goodman NSE Coronary Dilatation Catheter in the control 
group can reach the equivalent level, then the device success rate is expected to 
reach 96% [10, 14-17]. Considering the influence of factors such as the procedure 
level of different investigators, the complexity of lesions, and the comorbidities 
and severity of illness of subjects, the sponsor, clinical experts, investigators and 
statistical experts jointly decide that the non-inferiority margin δ is taken as -10%, 
the one-sided test α is set to be 0.025, and the test power (1-β) is 0.8. The total 
sample number is calculated as 122 using the PASS software, with 61 each in test 
group and control group. In consideration of a 10% dropout rate, this study 
requires 136 subjects, 68 each in test group and control group. The formula for 
calculation of sample size is shown as follows: 
 
Note: nT and nC are the sample sizes of test group and control group, respectively, 
and Z1-α/2 and Z1-β are the quartiles of the standard normal distribution; when 
α=0.025, Z1-α/2 = 1.96, and when β=0.2, Z1-β=0.842; (Z1-α/2+Z1-β) 2=7.85; PT and 
PC are the predictive incidences of events in test group and control group, 
respectively, and |𝐷𝐷| is the absolute value of the expected rate difference between 
the two groups |𝐷𝐷| = |𝑃𝑃𝑇𝑇−𝑃𝑃𝐶𝐶|, and ∆ is the non-inferiority margin, being 
negative. 
6.1.2 Allocation of Sample Size 
The inclusion/exclusion criteria for the selected subjects are strictly restricted in 
this trial protocol, and all selected 136 subjects are diagnosed with coronary artery 
stenosis (including in situ or restenotic lesions). The subjects screened are 
randomized at 1:1 to receive the investigational medical device or the control 
device for treatment, and the device success rate is set as the primary endpoint. 
6.1.3 Minimum and Maximum Number of Subjects in Each Site and 
Justification 
This trial will be carried out at the same time in multiple study sites. In principle, 
the number of subjects enrolled in each site will be distributed as evenly as 
possible to ensure adequate site representation. However, considering the 
feasibility and progress of the selection, the number of subjects enrolled in each 
participating site will be adjusted according to the actual situation, so as to ensure 
that the enrollment scale at each site is relatively balanced, and that the final 
enrollment scale for a specific site should not exceed 50% of the total number of 

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cases. 
6.2 Analysis Data Sets 
Statistical analysis will be carried out on the basis of the following analysis 
populations. The analysis populations will be clearly defined before the start of 
statistical analysis. And the analysis populations in this study include: 
(1) Full Analysis Set (FAS): the set of subjects determined following the intent-
to-treat (ITT) principle refers to the data set constituted by all subjects who 
participate in the randomized study and receive the investigational product. 
The worst observation carried forward (WOCF) is used for imputation of the 
patients in whom the Primary efficacy endpoint is unable to be observed. 
(2) Per-Protocol Set (PPS): refers to the subgroups of treatment population 
where the study has been completed with the major protocol violations 
excluded (which means that the subjects violate the inclusion criteria or 
exclusion criteria, etc.). 
(3) Safety set (SS): refers to the subject dataset using investigational medical 
devices and having recorded safety endpoints. 
The efficacy analysis will be performed based on the FAS and PPS. All baseline 
demographic data analysis will be performed on the FAS while the safety 
evaluation will be on the SS. 
6.3 Subject Elimination Criteria 
(1) The subjects seriously violate the inclusion/exclusion criteria, affecting the 
evaluation of the primary endpoint. 
(2) The subjects do not use the test devices for treatment after inclusion, or have 
no any visit record although they meet the inclusion criteria. 
6.4 Statistical Methods 
6.4.1 Statistical Design 
This study is a prospective, multicenter and randomized controlled design, with 
comparison type of non-inferiority test. It is to demonstrate that the 
investigational medical device also meets the needs of clinical application 
through comparison with the similar products that have been marketed, with the 
primary endpoint set as device success rate (lesion level); the corresponding 
statistical hypothesis test is: 
 
Where, PT is the expected device success rate in the test group, PC is the expected 
device success rate in the control group, and ∆ is the non-inferiority margin. 

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6.4.2 Statistical Analysis Methods 
(1) General Principles for Statistical Analysis 
In this study, SAS software is used for data description and analysis. All statistical 
tests are conducted by two-sided test (unless otherwise specified). The 95% 
confidence is adopted for the confidence interval (CI). In addition to the statistical 
methods listed below, detailed and additional exploratory analyses may be 
required and confirmed in the Study Reports and Statistical Analysis Plan (SAP). 
1) Statistical description: For the description of quantitative indicators, the 
mean, standard deviation (SD), median, minimum, maximum, lower quartile 
(Q1) and upper quartile (Q3) will be calculated; for the categorical indicators, 
the number of cases and percentage for each category will be described. 
2) Statistical inference: The inter-group comparison in general condition will be 
conducted by using appropriate method according to the types of indicators. 
The inter-group comparison in quantitative data will be conducted by the 
group t-test (homogeneity of variance and normal distribution) or Wilcoxon 
rank sum test according to the data distribution. The categorical data will be 
analyzed by the Chi-squared Test or Exact Test (if the Chi-squared Test is not 
applicable), while the ranked data will be analyzed by the Wilcoxon rank sum 
test or CMH test. 
(2) Completion and Baseline Analysis 
The number of subjects enrolled and the completion status of enrollment of each 
site should be summarized, and the drop-out cases should be listed. Different data 
set sizes in each group, case distribution of each site, total drop-out rate 
comparison and reasons for discontinuation, should be tabulated in detail. The 
demographic characteristics (age and gender), the relevant medical history and 
the treatment history of the patients are described, and the comparison of age and 
gender, etc. between the two groups will be conducted to measure the 
comparability between the two groups. Demographic analysis is based on FAS. 
(3) Primary efficacy endpoint 
The Primary efficacy endpoint of this study is the device success rate (lesion 
level), and the hypothesis test is as follows: 
Null hypothesis: PT-PC ≤ -10% 
Alternative hypothesis: PT - PC > -10% 
Under α=0.025 (one-sided test) and ß=0.2, the device success rate (lesion level) 
is compared between the test group and control group, and the difference between 
the two groups and the 95%CI of such difference are calculated to determine 
whether the non-inferiority margin is met based on the lower limit of CI. Non-
inferiority is established if the lower limit of 95%CI is not lower than -10%. If 

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central effect is to be considered, CMH's chi-square test is used. 
(4) Secondary efficacy endpoints 
The secondary efficacy evaluation is based on FAS and PPS. For the statistical 
description and inference of the data, the applicable descriptive indicators and 
hypothesis test methods are selected based on the characteristics of the data. 
(5) Safety endpoints 
Descriptive analysis is performed on safety endpoints data, and the number, 
incidence and case-times of all AEs, related AEs and SAEs in the two groups are 
calculated. The cases who discontinue the study due to AEs and who experience 
SAEs are presented in a list. 
6.4.3 Significance Level and Power of Clinical Study 
In this trial, for the primary endpoint, the significance level of statistical test is 
0.025% one-sided, and the power of test is taken as 80%. For other indicators, the 
significance level of statistical test is taken as 0.05 two-sided. 
6.4.4 Expected Drop-out Rate 
In determining the sample size, the highest possible drop-out rate during the study 
is expected to be 10%, including all conditions that make the subjects ultimately 
excluded from the primary analysis, often referring to major deviation of trial 
protocol (affecting the primary efficacy evaluation and/or safety evaluation) 
adjudicated by the PIs. 
6.4.5 Pass/Fail Criteria for Clinical Trial Results 
Determining whether the study result is acceptable from a statistical perspective 
is equivalent to verifying the initial hypothesis testing. For this study, the primary 
evaluation indicator is the device success rate (lesion level). In comparison type, 
this is non-inferiority test. It is planned to prove through the study results that the 
test group had the same therapeutic effect as compared with the control group. 
In conclusion, the judgment of the study results will be based on the difference in 
device success rate between the test group and control group. If the results show 
that the lower limit of 95%CI for the difference in device success rate between 
test group and control group is greater than -10% (the pre-specified non-
inferiority margin), the non-inferiority is established. Otherwise, the non-
inferiority conclusion is not established. 
6.4.6 Criteria for Termination of Trial Based on Statistics and Justification 
The interim analysis and its corresponding early termination criteria are not pre-
established in this trial, so this section is not applicable. All statistical analyses 
are conducted after the completion of data collection, cleansing and final locking. 
6.4.7 Procedures for Reporting Deviation from Original Statistical Plan 

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The statistical analysis plan needs to be confirmed by the sponsor and the PIs, 
and finalized before database locking. Prior to finalization, the initial analysis 
plan should be modified according to the actual conditions in the trial process. In 
principle, the main analysis principles, methods and analysis sets should not be 
modified, and all the modifications will be recorded. 
6.5 Missing Data and Outliers 
Method for the treatment of missing data: The missing data will be processed 
according to the division of the data set; primary efficacy data will be imputed 
with the use of the WOCF (Worst Observation Carry Forward). 
Wrong data handling method: In the process of data management, the quality 
management will be performed for the data in the database, wrong data found will 
be questioned in the form of Query to investigators, and the wrong data will be 
adjusted according to the written reply of investigators until all wrong data is 
corrected before locking the database. 
Unreasonable data handling method: In the process of data management, the data 
in the database will be checked logically, unreasonable data found will be 
questioned in the form of Query to investigators, and the unreasonable data will 
be adjusted according to the written reply of investigators until all unreasonable 
data is solved before locking the database. 
7. Monitoring Plan 
The sponsor should assume the responsibility for the monitoring of the medical 
device clinical trial, establish the SOPs for monitoring and choose qualified CRA 
to perform the monitoring duties. The monitoring plan is as follows:  
(1) Monitoring visits include: before start-up visit, start-up visit, routine process 
visit, unconventional visit, and closing visit; 
(2) Monitoring frequency: The number of CRAs and the monitoring frequency 
should depend on the complexity of the medical device clinical trial and the 
number of study sites involved in the trial. 
(3) CRA qualification: The CRA should be trained accordingly, be familiar with 
the GCP and relevant laws and regulations, have relevant professional 
knowledge, be familiar with relevant study data of the investigational 
medical device, clinical information of the similar products, clinical trial 
protocol and related documents, and be able to effectively fulfill the 
monitoring duties; the CRA should abide by the SOPs for monitoring 
developed by the sponsor, and urge the medical device clinical trial to be 
carried out according to the clinical trial protocol. 
(4) Monitoring contents: compliance of medical device study sites and 
investigators with the clinical trial protocol, the GCP and relevant laws and 

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regulations in the implementation of clinical study; signing of ICF by 
subjects, screening of subjects, follow-up, rights and interests, and safety 
guarantee; the management and use of investigational medical devices and 
control devices (if applicable); the management and use of biological samples 
(if applicable); handling of adverse events and device defects; reporting of 
safety information; recording of clinical trial data and filling of CRFs. 
8. Data Management 
The Electronic Data Capture (EDC) system is used to collect the trial data. The 
EDC system has been strictly tested and fully complies with the requirements of 
Good Clinical Practice for Medical Devices and Technical Guidance for Data 
Management in Clinical Trials. Before the system is formally launched, the 
relevant users need to be trained and assessed to ensure that the system meets the 
trial requirements. After the official launch, relevant personnel will be provided 
with the account and password. The account is bound with the role and authority 
of the user who is required to properly keep and not to disclose the account 
information to others or exercise corresponding rights on behalf of others. 
8.1 Data Collection 
The EDC directly transmits data from the client to the server through the Internet. 
Investigators can directly enter the source data into the EDC system to complete 
data collection. Investigators should be responsible for the quality of the entered 
data and ensure the authenticity and integrity of the data. The EDC system 
provides an interface printing function that allows the investigators to print the 
electronic case report form (eCRF) as required. 
8.2 Data Verification and Modification 
The EDC system provides on-line and off-line verification methods. When 
investigators have entered abnormal data, the EDC system will issue real-time 
warnings to remind them to check; and the data administrator performs logical 
check on the data stored in the server and issues the wrong data through EDC in 
the form of manual query. Investigators need to answer all published queries. The 
CRA needs to periodically remind and assist the investigators in answering 
queries to ensure that each query is handled correctly. The system will record all 
queries and answers thereto. 
8.3 Database Locking 
When all data entry is completed and submitted, and all queries are answered, the 
system enters a soft locking status. The data administrator will generate a blinded 
review report based on the database. If it is confirmed that the data would not be 
modified, the sponsor, the person in charge of data administration and the person 
in charge of statistics will sign the database locking form, and the data 
administrator would complete the database locking operation according to the 

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form. The locked database cannot be modified again. If there is any wrong data 
that affects the primary efficacy endpoint or safety endpoints, the sponsor, the 
person in charge of data administration and the person in charge of statistics will 
confirm the unlocking for modification and sign the database unlocking form, and 
the data administrator will modify the wrong data according to the unlocking 
reason and carry out quality control. The sponsor, the person in charge of data 
administration and the person in charge of statistics will sign the database locking 
form again once the error has been corrected. 
9. Risk-Benefit Analysis 
9.1 Benefit Analysis 
PTCA, as the most basic method in the PCI of coronary artery stenosis lesions, 
has been widely used in patients with coronary artery in situ lesions or ISR. Based 
on data of its previous clinical applications, PTCA shows potential benefits in 
improving patients' symptoms and quality of life that outweigh possible risks 
associated with the use of such products. This also benefits from the design of the 
scoring balloon itself, with three wound Ni-Ti alloy elements to the outside of the 
common balloon. Therefore, compared with the risks such as late stent delivery 
failure and stent incomplete expansion caused by the blunt, disorderly dilated 
lesion with the common balloon, the scoring balloon dilates lesions in such a way 
that plaque cracks can be formed in an effective and relatively regular manner, 
thus obtaining ideal stent implantation, effectively reducing the restenosis and the 
risk of in-stent thrombosis, and ultimately affecting the whole procedure time and 
procedural success rate [18-20]. 
In addition, there is also a possibility that subjects do not directly benefit from 
enrollment in this trial, but the results of the trial will also help to improve existing 
treatment methods and benefit the patients with coronary artery stenosis requiring 
balloon dilation in the future. 
9.2 Potential Risk Analysis 
There may be some risks involved in participating in this trial, but the risks are 
not expected to be substantially different from those experienced by individuals 
receiving balloon dilation or PCI outside of the trial. Patient risks are managed 
and reduced by fully evaluating the potential risks and benefits of subjects, 
providing comprehensive trainings to the investigators, and conducting regular 
monitoring visits during the clinical trial process, and adhering to the 
recommended peri-procedural medication regimen. 
10. Quality Control of Clinical Trial 
(1) Quality Control Measures of the Laboratory 
The laboratories of the participating clinical trial institutions should have quality 

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control procedures for all observed indicators of this trial. 
(2) Training for Clinical Trial 
Before the initiation of the clinical trial, the relevant personnel of the clinical trial 
will be trained, and the investigators of each site will be trained by organizing the 
kick-off meeting, including the clinical protocol, informed process, device use, 
and document filling, etc. In the course of the trial, targeted training will be 
provided to the investigators and the relevant personnel of the trial according to 
the actual clinical situation. 
(3) Monitoring of Clinical Trial 
During the clinical trial, the CRA will conduct regular monitoring visits at the 
study site according to the monitoring plan, to ensure that all the contents in the 
study protocol are strictly observed, and will check the raw data to ensure that the 
filled contents of EDC are true, complete and correct. 
(4) Retention of Raw Data 
The raw data of this trial include the signed ICF, release records of test products, 
relevant laboratory test reports, case records and other related records, which 
should be retained at the clinical trial institute of the hospital where the study site 
is located. All raw data and printed CRF should be retained for 10 years after 
completion or termination of the clinical trial. 
11. Ethical Issues and Informed Consent in Clinical Trial 
11.1 Ethical Considerations 
This clinical trial is conducted in compliance with the Declaration of Helsinki of 
the World Medical Association and applicable laws and regulations of China. 
Before the clinical trial, the investigators need to submit the clinical trial protocol, 
ICF and other related documents to the Medical Ethics Committee of hospitals 
where the study sites are located. The clinical trial will be started only after 
obtaining the approval of the EC. Any amendment to the study protocol must be 
approved by the EC before it can be implemented. SAEs during the clinical trial 
shall be submitted to the EC in writing timely. 
11.2 Informed Consent Process 
The investigators should comply with the codes of ethics and relevant ethical 
requirements of the Declaration of Helsinki of the World Medical Association. 
Before subjects participate in the clinical trial, the investigators should inform the 
subjects of the details of the investigational medical device and clinical trial, as 
well as the possible benefits and known and foreseeable risks. After full and 
detailed explanation by the investigators, both the subjects and investigators 
should sign and date the ICF; where a subject is a person without or with limited 
capacity for civil conduct, the written informed consent should be obtained from 

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his/her guardian; if any subject lacks reading ability, an impartial witness should 
be present to witness the whole informed consent process, and sign and date the 
ICF. The investigators should not compel or otherwise improperly induce the 
subjects to participate in the clinical trial; 
The investigators should use the latest version of the ICF approved by the EC and 
other information provided to subjects. Where the ICF is revised in the course of 
the trial, the revised ICF should not be implemented until the written consent of 
the EC has been obtained again. When the ICF is updated and reviewed and 
approved by the EC, the investigators should ensure that all the subjects who have 
been affected and have not finished the trial procedures sign the newly revised 
ICF. 
12. Provisions for AE and Device Defect Reporting 
12.1 Definition of AE and Provisions for AE Reporting 
Adverse event (AE) refers to an adverse medical event that occurs during the 
medical device clinical trial, related or unrelated to the investigational medical 
device. 
AEs after treatment with the investigational product must be recorded truthfully 
in the Adverse Event Form. Record the duration of AEs (that is, from start to 
end), severity, and correlation with the clinical study as well as the corresponding 
treatment and other management measures. Follow-up shall be made to the end 
of the trial or the outcome of adverse events. 
In this clinical trial, the following conditions may not be recorded as an AE: 1) 
hematoma less than 6 cm or a small amount of bleeding at the puncture site; 2) 
common stress reactions post-procedure, such as fever and weak dorsalis pedis 
artery pulse; 3) abnormal laboratory indicators post-procedure are clinically 
significant, but the investigators do not take corresponding treatment measures, 
and the subjects resolve spontaneously. 
12.2 Device Defect 
The device defect refers to the unreasonable risk that may endanger the human 
health and life safety in the normal use of the medical device during the clinical 
trial, such as label errors, quality problems and failures. 
The investigators should record the device defects occurred or found during the 
clinical trial and analyze the cause of the event together with the sponsor, form a 
written analysis report, propose the opinions on continuing, suspending or 
terminating the trial and report to the EC through the management department of 
medical device clinical trials of the clinical study sites for review. 
The investigators and subjects can make complaints against the test devices at 
any phase of this clinical study. 

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12.3 Definition of SAE 
The SAE refers to the event that causes death or serious deterioration of health in 
the process of clinical trial, including: 
(1) Fatal disease or injury; 
(2) Permanent impairment of a body structure or a body function; 
(3) Requiring 
in-patient 
hospitalization 
or 
prolongation 
of 
existing 
hospitalization; 
(4) Requiring medical measures to prevent permanent impairment of the body 
structure or body function; 
(5) Leading to fetal distress, fetal death or congenital abnormality, or congenital 
defect, etc. 
Hospitalization or prolongation of hospitalization cannot be considered an SAE 
if at least one of the following exceptions is met: 
 
Pre-planned hospitalizations (e.g., scheduled elective or scheduled 
operations or examinations prior to study start) 
 
Hospitalization not related to an AE (e.g., community hospitalization for 
short-term or long-term care purposes) 
However, any interventional therapy performed during hospitalization may meet 
the criteria for an "Important Medical Event" and may be reported as a SAE based 
on clinical judgment. In addition, if local regulatory authorities specifically 
require stricter definitions, local regulations shall prevail. 
12.4 Reporting Procedures and Contact Information 
In case of SAEs in the medical device clinical trial, the investigators should 
immediately take appropriate treatment measures for subjects; at the same time, 
the investigators should report to the sponsor, the management department of 
medical device clinical study site and the EC within 24 hours after awareness of 
SAEs; follow up these SAEs according to the provisions of the clinical trial 
protocol, and submit the follow-up report of SAEs; 
The sponsor should, within 7 days after being aware of death or life-threatening 
SAEs related to the investigational medical device, or within 15 days after being 
aware of non-death or non-life-threatening SAEs related to the investigational 
medical device and other serious safety risk information, report to other medical 
device clinical trial institutions, ECs and PIs participating in the clinical trial, 
report to local medical products regulatory authority of the province, autonomous 
region or municipality directly under the central government where the sponsor 
is located, report to the medical products regulatory authorities and health 
administrations of the provinces, autonomous regions or municipalities directly 
under the central government where the medical device clinical trial institutions 

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are located, and take risk control measures. 
See Appendix 2 for the contact information. 
13. Deviation from Clinical Trial Protocol and Regulations for Protocol 
Amendment 
Before the start of the clinical verification, the trial protocol is discussed, revised, 
finalized and signed by each investigator and the sponsor, and then reported to 
the EC for approval, which the trial can be initiated then. 
If this protocol has problems in clinical verification and actual implementation 
that need to be revised, the investigators should be informed of. After the 
multicenter discussion, the protocol shall be revised by the leading site. 
During the clinical study, if the existing participating sites fail to obtain the 
approval of the clinical trial administrative department or the EC, resulting in the 
progress of the study significantly slower than the expected schedule, the sponsor 
should fully communicate and discuss with the coordinating investigator, and 
then make adjustments to the participating sites (abandonment or addition), and 
may update the list of clinical study sites in the Appendix without amending the 
text of the protocol. The final list of participating sites should be submitted to the 
clinical trial management departments and ECs of all participating sites for filling. 
If the important new information regarding the investigational medical device 
becomes available, the ICF must be revised in writing and re-approved by the EC 
before obtaining consent from subjects once again. 
In the event of deviation from the protocol during the course of the trial, the 
investigators should promptly notify the sponsor and the EC. 
14. Direct Access to the Source Data and Documents 
In this clinical study, the PIs and their authorized investigators can access and 
generate inpatient medical records, ICF of subjects, EDC and original medical 
records in HIS system. 
The laboratory inspection personnel and investigators can access and generate the 
inspection result report issued by them. The data administrator can access and 
generate the data of data management; the statistical analyst can access and 
generate the statistical analysis data. The access and editing permissions of the 
remaining source data shall, in accordance with the requirement of the relevant 
laws and regulations and technical specifications in China, be specified in detail 
by SOP of the corresponding department. 
15. Contents to be Covered in Clinical Trial Report 
The clinical trial report generally includes basic information on the medical 
device clinical trial, implementation, statistical analysis methods, trial results, 

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AEs and device defect reporting and handling, analysis and discussion of trial 
results, clinical trial conclusions, ethical situation, existing problems and 
suggestions for improvement, etc. 
16. Confidentiality Principle 
This Protocol and the contents of this clinical trial and all the attached data are 
confidential and proprietary information of the sponsor, and the investigators 
shall be held responsible for confidentiality, including the patent application, 
manufacturing process and unpublished data available to the investigators 
provided by the sponsor, which shall not be disclosed to any third party unless 
the consent of the sponsor is obtained and the obligation of confidentiality shall 
survive the termination or end of this trial. 
17. Responsibilities Assumed by All Parties 
All parties shall strictly implement the relevant provisions in accordance with the 
Good Clinical Practice for Medical Devices ([2022] Announcement No. 28, 
hereinafter referred to as "GCP"). 
17.1 Responsibilities of Investigators 
(1) The investigators should participate in the training related to the medical 
device clinical trial organized by the sponsor, and participate in the medical 
device clinical trial within the scope authorized by the PIs. 
(2) The investigators should be familiar with the principle, indications for use or 
intended use, product performance, operation methods, installation 
requirements and technical indicators etc. of the investigational medical 
device, and understand the pre-clinical study related data of the 
investigational medical device. 
(3) The investigators should fully understand and comply with the clinical trial 
protocol, the GCP and applicable laws and regulations, as well as 
responsibilities related to the medical device clinical trial. 
(4) The investigators should bear management responsibilities for the 
investigational medical device and control device (if applicable) provided by 
the sponsor, ensure that they are only used for subjects participating in the 
medical device clinical trial, store and keep them as required during the 
clinical trial, and handle them according to relevant laws and regulations as 
well as the contract with the sponsor after the completion or termination of 
the clinical trial. 
(5) The investigators should ensure that the collection, processing, storage, 
transportation, and destruction of biological samples comply with the 
clinical trial protocol and applicable laws and regulations during the medical 
device clinical trial. 

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(6) When receiving the SAE and other safety information related to the 
investigational medical device provided by the sponsor, the PIs should sign 
in and read it in a timely manner, consider whether to make corresponding 
adjustment to the treatment for subjects, and communicate with the subjects 
as soon as possible if necessary. 
(7) When receiving a notice from the sponsor or the EC that needs to suspend 
or terminate the medical device clinical trial, the PIs should inform the 
subjects timely and ensure that the subjects are properly treated and 
followed up. 
(8) The PIs should ensure that the medical device clinical trial follows the latest 
version of clinical trial protocol approved by the EC; and ensure that the 
medical device clinical trial is conducted in accordance with the GCP and 
applicable laws and regulations within the agreed time limit. 
(9) The PIs may authorize the investigators that have received clinical trial 
related trainings to organize the enrollment and informed consent of 
subjects, screening and follow-up, management and use of the 
investigational medical device and the control device (if applicable); 
management and use of biological samples (if applicable); handling of AEs 
and device defects, and recording of clinical trial data and filling of CRF 
according to the needs of the medical device clinical trial. 
(10) The PIs should inform the EC of the progress of the medical device clinical 
trial, events affecting the rights and interests as well as the safety of subjects, 
as well as the deviation from the clinical trial protocol on time. 
17.2 Responsibilities of Medical Device Clinical Trial Institutions 
(1) Medical device clinical trial institutions should meet the filing requirements, 
and establish the management organizational structure and management 
system for clinical trials. Medical device clinical trial institutions should 
have corresponding clinical trial management department to undertake the 
management of medical device clinical trials. 
(2) The management departments of medical device clinical trial institutions 
should be responsible for filling in, managing and changing the filing 
information of medical device clinical trial institutions in the filing 
management information system of medical device clinical trial institutions, 
including the information of clinical trial specialties and PIs; online 
submitting the summary report of medical device clinical trials of the 
previous year in the filing system; organizing the evaluation on the 
qualifications of the PIs of the clinical trial and completing the filing before 
the review of the medical device clinical trial by the EC. 
(3) Medical device clinical trial institutions should establish a quality 

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management system, covering the whole implementation process of medical 
device clinical trials, including such systems as training and assessment, 
implementation of clinical trials, management of medical devices, 
management of biological samples, handling of adverse events and device 
defects and reporting of safety information, recording, and quality control, 
so as to ensure that the PIs fulfill their responsibilities related to the clinical 
trials, guarantee that subjects can receive proper medical treatment and 
ensure the authenticity of data generated in the trial. 
(4) Before accepting a medical device clinical trial, medical device clinical trial 
institutions should evaluate relevant resources according to the 
characteristics of the investigational medical device to ensure that 
appropriate qualifications, personnel, facilities, and conditions are available. 
(5) Medical device clinical trial institutions and investigators should cooperate 
with the monitoring and audit organized by the sponsor and the inspection 
conducted by medical products regulatory authorities or health 
administrations. 
(6) Medical device clinical trial institutions should properly keep the clinical 
trial records and essential documents according to applicable laws and 
regulations and the contract with the sponsor. 
(7) Where the sponsor seriously or continuously violates the GCP and 
applicable laws and regulations, or requires changes in trial data and 
conclusion, medical device clinical trial institutions and investigators should 
report in writing to the medical products regulatory authority of the 
province, autonomous region or municipality directly under the central 
government where the sponsor is located. 
17.3 Responsibilities of Sponsor 
(1) 
The sponsor should be responsible for the authenticity and compliance of 
the medical device clinical trial. 
(2) 
The sponsor should have its quality management system cover the whole 
process of medical device clinical trials, including the selection of medical 
device clinical trial institutions and PIs, design of clinical trial protocol, and 
the implementation, recording, result reporting and document archiving of 
medical device clinical trials. Its quality management measures should 
accommodate to the risks of the clinical trial. 
(3) 
Before initiating a medical device clinical trial, the sponsor should ensure 
that the product design has been finalized, the pre-clinical study of the test 
medical devices has been completed and its results should be able to support 
the medical device clinical trial. 
(4) Before initiating a medical device clinical trial, the sponsor should, according 

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to the characteristics of the investigational medical device, select medical 
device clinical trial institutions, specialties and PIs that have completed the 
filing. 
(5) 
In a multicenter clinical trial, the sponsor should be responsible for selecting 
and determining the coordinating investigator for the medical device 
clinical trial, and the medical institution where the coordinating investigator 
works is the leading site. The coordinating investigator undertakes the 
coordination of various sites in the multicenter clinical trial, and ensure 
communication among PIs in various sites. 
(6) 
Before initiating a medical device clinical trial, the sponsor should be 
responsible for organizing the formulation of the investigator’s brochure 
(IB), clinical trial protocol, ICF, CRF, SOPs and other relevant documents, 
and provide them to medical device clinical trial institutions and PIs. 
(7) 
The sponsor should sign a contract with medical device clinical trial 
institutions and the PIs to specify their respective rights and obligations in 
the medical device clinical trial. 
(8) 
The sponsor should file the clinical trial at the medical products regulatory 
authority of the province, autonomous region and municipality directly 
under the central government where it is located after the medical device 
clinical trial has been approved in EC review and the contract with medical 
device clinical trial institutions has been signed. After a medical device 
clinical trial has been filed, the medical device clinical trial institution can 
start the informed consent and screening of the first subject. 
(9) 
Before the start of the medical device clinical trial, the sponsor should be 
responsible for organizing trainings related to the medical device clinical 
trial, such as trainings on the rationale, indications for use, product 
performance, operation methods, installation requirements and technical 
indicators of the investigational medical device, and the clinical trial 
protocol and SOPs as well as other relevant documents. 
(10) The sponsor should provide the investigational medical device free of 
charge, and should meet the requirements of Article 42 of the GCP. 
(11) The sponsor should pay the expenses related to the medical device clinical 
trial for subjects. 
(12) The sponsor should be responsible for the evaluation and reporting of the 
safety information during the medical device clinical trial. 
(13) The sponsor should assume the responsibility for the monitoring of the 
medical device clinical trial, establish SOPs for monitoring and choose 
qualified CRAs to perform the monitoring duties. 
(14) The sponsor should ensure that the medical device clinical trial is 

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implemented in strict accordance with the clinical trial protocol. The 
sponsor should promptly point out and rectify the noncompliance of 
medical device clinical trial institutions and investigators with the clinical 
trial protocol, the GCP and relevant laws and regulations; where the 
situation is serious or continued, the sponsor should terminate the 
participation of such clinical trial institutions and investigators in the 
clinical trial and report it to the medical products regulatory authorities of 
the provinces, autonomous regions or municipalities directly under the 
central government where such clinical trial institutions are located. 
(15) The sponsor should report to all the PIs, management departments of 
medical device clinical trial institutions and the ECs within 10 working days 
upon the suspension, termination or completion of the medical device 
clinical trial. The sponsor should report to the medical products regulatory 
authority of the province, autonomous region or municipality directly under 
the central government where it is located within 10 working days upon the 
termination or completion of the medical device clinical trial. 
18. Other Contents to Be Addressed 
None. 
19. References 
[1] An J, Li B, Wang JP, et al. Comparative study of cutting balloon and 
percutaneous transluminal coronary angioplasty in the treatment of small 
coronary vascular lesions. Shanxi Med J. 2009;38(11):1032-1033. 
[2] Huang ZY, Qian JY, Jun-Bo GE. Very late stent thrombosis due to multiple 
stent fracture and stent malapposition. Chinese Medical Journal. 
2013;126(001):186-189. 
[3] Barbato E CD, Dardas P, Fajadet J. European expert consensus on rotational 
atherectomy. Eurointervention Journal of Europcr in Collaboration with the 
Working Group on Interventional Cardiology of the European Society of 
Cardiology. 2015;11(1):30-36. 
[4] Ge JB. White paper on innovation of Chinese cardiovascular device industry 
(2021). Center for Cardiovascular Innovations.2021;201-204. 
[5] Kassimis G, Raina T, Kontogiannis N, et al. How Should We Treat Heavily 
Calcified Coronary Artery Disease in Contemporary Practice? From 
Atherectomy to Intravascular Lithotripsy. Cardiovasc Revasc Med. 
2019;20(12):1172-1183. 
[6] Mauri L, Bonan R, Weiner BH, et al. Cutting balloon angioplasty for the 
prevention of restenosis: results of the Cutting Balloon Global Randomized 
Trial. The American Journal of Cardiology. 2002;90(10):1079-1083. 

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[7] PMA P200041: FDA Summary of Safety and Effectiveness Data. 
[8] https://www.clinicaltrials.gov/ct2/show/NCT04985773?term=NCT049857
73&draw=2&ra nk=1 
[9] Auer J, Maurer E, Berent R, Mayr H, Punzengruber C, Weber T, Lassnig E, 
Eber B. Clinical and angiographic outcome after cutting balloon angioplasty. 
J Interv Cardiol. 2003 Feb;16(1):15-21. 
[10] PMA P050018: FDA Summary of Safety and Effectiveness Data. 
[11] Lee SH, Choi SH, Ko YG, Choi D, Jang Y, Shim WH. Self-expanding 
coronary stent (Radius) implantation with cutting balloon angioplasty. 
Cardiology. 2005;103(3):123-7. 
[12] Dehmer GJ, Badhwar V, Bermudez EA, Cleveland JC Jr, Cohen MG, 
D'Agostino RS, Ferguson TB Jr, Hendel RC, Isler ML, Jacobs JP, Jneid H, 
Katz AS, Maddox TM, Shahian DM. 2020 AHA/ACC Key Data Elements 
and Definitions for Coronary Revascularisation: A Report of the American 
College of Cardiology/American Heart Association Task Force on Clinical 
Data Standards (Writing Committee to Develop Clinical Data Standards for 
Coronary Revascularisation). Circ Cardiovasc Qual Outcomes. 2020 
Apr;13(4):e000059. 
[13] Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus 
J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, 
Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys 
PW; Academic Research Consortium. Standardized End Point Definitions 
for Coronary Intervention Trials: The Academic Research Consortium-2 
Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. 
[14] Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, López -Minguez 
JR, Angel J, Augé JM, Gómez -Recio M, Morís C, Seabra -Gomes R, Perez-
Vizcayno MJ, Macaya C; Restenosis Intra-stent: Balloon Angioplasty 
Versus Elective Stenting (RIBS) Investigators. A randomized comparison of 
repeat stenting with balloon angioplasty in patients with in-stent restenosis. 
J Am Coll Cardiol. 2003 Sep 3;42(5):796-805. 
[15] SJ Li，LM Pan，XK Hu, et al. Evaluation on efficacy and safety of 
Lacrosse non-slip element balloon.Chin J Clin Res.2021;34(2)：217-223. 
[16] Umeda H, Iwase M, Kanda H, Izawa H, Nagata K, Ishiki R, Sawada K, 
Murohara T, Yokota M. Promising efficacy of primary gradual and 
prolonged balloon angioplasty in small coronary arteries: a randomized 
comparison with cutting balloon angioplasty and conventional balloon 
angioplasty. Am Heart J. 2004 Jan;147(1):E4. 
[17] Karvouni E, Stankovic G, Albiero R, Takagi T, Corvaja N, Vaghetti M, Di 

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Mario C, Colombo A. Cutting balloon angioplasty for treatment of calcified 
coronary lesions. Catheter Cardiovasc Interv. 2001 Dec;54(4):473-81. 
[18] Park DW, Park SW, Park KH, Lee BK, Park SJ. Frequency of and Risk 
Factors for Stent Thrombosis After Drug-Eluting Stent Implantation During 
Long-Term Follow-Up. Digest of the World Core Medical Journals. 
2006;98(3):352-356. 
[19] Ashida K, Hayase T, Shinmura T. Efficacy of lacrosse NSE using the 
"leopard-crawl" technique on severely calcified lesions. journal of invasive 
cardiology. 2013;25(10):555-564. 
[20] Jr J, Mintz GS, Carlier SG, et al. Nonrandomized Comparison of Coronary 
Stenting Under Intravascular Ultrasound Guidance of Direct Stenting 
Without Predilation Versus Conventional Predilation With a Semi-
Compliant Balloon Versus Predilation With a New Scoring Balloon. 
American Journal of Cardiology. 2007;100(5):812-817. 
[21] Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, White HD. Fourth 
Universal Definition of Myocardial Infarction (2018). Circulation. 
2018;138(20): e618-e651. 
 
 

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Investigator's Statement 
I hereby agree that: 
1. I will carry out this clinical trial in strict compliance with the Declaration of 
Helsinki, current regulations of China and the requirements of this trial 
protocol. 
2. I will accurately record all data required in the CRF to complete the clinical 
trial report. 
3. I will make sure that the investigational medical device will be used only for 
the purpose of this clinical trial; and will completely and accurately record the 
receipt and use of the investigational medical device, with such records 
retained throughout the clinical trial. 
4. I will allow the CRA and auditors authorized or designated by the sponsor as 
well as regulatory authorities to conduct monitoring, audit and inspection on 
the clinical trial. 
5. I will strictly implement the terms in the clinical trial contract/agreement 
signed among parties. 
I have already read the clinical trial protocol entirely, including the above 
statement and I fully agree with all the above contents. Principal Investigator 
Principal Investigator 
 
Signature: <signed> 
July 08, 2022 
 
Medical Device Clinical Trial Institution 
 
Seal <stamped> 
July 11, 2022 
 
Sponsor 
 
Seal <stamped> 
July 5, 2022 
 
 

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Appendix 1 List of Study Sites and Principal Investigators 
Site name 
Principal Investigator 
Professional title 
Peking University First Hospital 
Li Jianping 
Chief Physician 
Peking University Third Hospital 
Tang Yida/Wang Guisong 
Chief Physician 
Chest Hospital of Tianjin City 
Cong Hongliang/Li Ximing 
Chief Physician 
Tianjin Fourth Center Hospital 
Wen Shangyu 
Chief Physician 
Xuzhou Cancer Hospital 
Zhang Yaojun 
Chief Physician 
The First People's Hospital of Lianyungang 
Yin Delu 
Chief Physician 
Wuxi People’s Hospital 
Wang Qiang 
Chief Physician 
Kaifeng Central Hospital 
Qin Lei 
Chief Physician 
Appendix 2 List of Contact Information for AE and Device Defect Reporting 
Site name 
Contact 
Tel. 
E-mail address 
Peking University First Hospital 
Yu Ronghui 
010-66119025 
bdyyec@163.com 
Peking University Third Hospital 
Hong Xue 
010-82265571 
bysygcp@163.com 
Chest Hospital of Tianjin City 
Pang Ruonan 
022-88185557 
xkyydb@126.com 
Tianjin Fourth Center Hospital 
Liu Haiyang 
022-26181877 
tjsszxjg@163.com 
Xuzhou Cancer Hospital 
Cao Shengya 
0516-85537719 
XZZLLL@126.com 
The First People's Hospital of 
Lianyungang 
Yang Jian 
0518-85767557 
irb_lygyyy@163.com 
Wuxi People’s Hospital 
Duan Ru 
0510-85351101 
wuxillwyh@163.com 
Kaifeng Central Hospital 
Qiu Yang 
0371-25672861 
kflcsyllwyh@126.com 
Note: Any increase or decrease of the site during the course of the trial will be documented separately as a 
separate document without amendment to the protocol. 
Appendix 3 Definition of Composite Endpoint 
Patient-oriented 
composite 
endpoint (PoCE) 
 
All-cause death; 
 
All myocardial infarction; 
 
All 
revascularisation 
events, 
including 
target 
lesion 
revascularisation (TLR), target vessel revascularisation (TVR), 
and target vessel non-target lesion revascularisation. 
Target lesion failure (TLF) 
 
Cardiac death (the death with uncertain cause is also considered 
cardiac death); 
 
Target vessel myocardial infarction (TV-MI); 
 
Clinically indicated target lesion revascularisation (CI-TLR). 
Appendix 4 Definition of Death 
Type of death 
Definition 
Cardiac death 
Refers to death due to cardiovascular causes, as detailed in the table below: 
1. 
Death due to acute myocardial infarction 
2. 
Death due to cardiac arrest, including deaths of unknown cause 
3. 
Death due to heart failure 
4. 
Death due to stroke 
5. 
Death due to cardiovascular procedure 
6. 
Death due to hemorrhage of cardiovascular system 
7. 
Death due to other cardiovascular diseases 

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Type of death 
Definition 
Non-cardiac death 
Refers to death due to non-cardiovascular causes, as detailed in the table below: 
1. 
Death due to malignancies 
2. 
Death due to pulmonary causes 
3. 
Death due to infection (including septicemia) 
4. 
Death due to digestive system 
5. 
Death due to accident/trauma 
6. 
Death due to organ failure other than the cardiovascular system 
7. 
Death due to other non-cardiovascular causes 
Death unexplained 
Death with undetermined cause or classification due to lack of relevant data will be 
considered cardiac death. 
Appendix 5 Myocardial Infarction (MI) (UD 2018) [21] 
Type 1 MI: thrombosis due to plaque disruption (rupture or erosion) 
Detection of a rise and/or fall of cTn values with at least one value above the 99th percentile upper 
reference limit (URL), and clinical evidence of acute myocardial ischemia, requiring at least one of the 
following: 
 
Symptoms of acute myocardial ischaemia; 
 
New ischemic ECG changes; 
 
Development of pathological Q waves; 
 
Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in 
a pattern consistent with an ischaemic aetiology; 
 
Identification of a coronary thrombus by angiography including intracoronary imaging or by 
autopsy a 
Note a: Post-mortem demonstration of an atherothrombus in the artery supplying the infarcted 
myocardium, or a macroscopically large circumscribed area of necrosis with or without intramyocardial 
haemorrhage, meets the type 1 MI criteria regardless of cTn values. 
Type 2 MI: MI secondary to ischemia or mismatch between oxygen supply and demand 
Detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL, and 
evidence of an imbalance between myocardial oxygen supply and demand unrelated to coronary 
thrombosis, requiring at least one of the following: 
 
Symptoms of acute myocardial ischaemia; 
 
New ischemic ECG changes; 
 
Development of pathological Q waves; 
 
Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in 
a pattern consistent with an ischaemic aetiology; 
Type 3 MI: MI that causes death and unable to provide the cardiac biomarker value 
Patients who suffer cardiac death, with symptoms suggestive of myocardial ischaemia accompanied by 
presumed new ischaemic ECG changes or ventricular fibrillation, but die before blood samples for 
biomarkers can be obtained, or before increases in cardiac biomarkers can be identified, or MI is detected 
by autopsy examination. 
Type 4a MI: PCI-related MI ≤ 48 h after the index procedure 
An elevation of cTn values > 5 times the 99th percentile URL in patients with normal baseline values; in 
patients with elevated pre-procedure cTn in whom the cTn level are stable (≤ 20% variation) or falling, 
the post-PCI cTn must rise by > 20%. However, the absolute post-procedural value must still be at least 
5 times the 99th percentile URL. In addition, one of the following elements is required: 
 
New ischemic ECG changes; 
 
Development of pathological Q waves; 
 
Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in 
a pattern consistent with an ischaemic aetiology; 
 
Angiographic findings consistent with a procedural flow-limiting complication such as coronary 

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dissection, occlusion of a major artery or a side branch occlusion/thrombus, or distal 
embolization. 
Type 4b MI: In-stent thrombosis-related MI 
A subcategory of PCl-related Ml is in-stent thrombosis, using the same criteria utilized for type 1 MI, and 
what is special about this type of MI is that it occurs after stent implantation. It is important to indicate 
the time of the occurrence of the stent thrombosis in relation to the timing of the PCI procedure. The 
following temporal categories are suggested: acute, 0-24 h; subacute, > 24 h to 30 days; late, > 30 days to 
1 year; and very late > 1 year after stent implantation. 
Type 4c MI: restenosis-related MI 
During angiography in some patients with suspected MI, it is found that ISR or balloon dilation-related 
restenosis is the only possible explanation for the occurrence of MI. This PCI-related MI type is designated 
as type 4c MI, associated with a rise and/or fall of cTn values with at least one value above the 99th 
percentile URL. 
Type 5 MI: CABG-related MI ≤ 48 hours after the index procedure 
An elevation of cTn values > 10 times the 99th percentile URL in patients with normal baseline values; 
in patients with elevated pre-procedure cTn in whom the cTn level are stable (≤ 20% variation) or falling, 
the post-CABG cTn must rise by > 20%. However, the absolute post-procedural value must still be > 10 
times the 99th percentile URL. In addition, one of the following elements is required: 
 Development of pathological Q waves; 
 Angiographic documented new graft occlusion or new native coronary artery occlusion; 
 Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a 
pattern consistent with an ischaemic aetiology; 
Appendix 6 Definition of Revascularisation 
Type 
Definition 
Target lesion 
Refers to the vascular segments within the lesion to be 
intervened, and within 5 mm in front and behind the lesion 
Target lesion revascularisation (TLR) 
PCI or CABG performed again at the lesion in order to 
treat target lesion restenosis or other complications 
Target vessel 
The main coronary artery in which the target lesion is 
located, containing its branches 
Target vessel revascularisation (TVR) 
Any, repeated PCI or CABG for any segment of target 
vessels (including target lesions) 
Target 
vessel 
non-target 
lesion 
revascularisation 
PCI or CABG intervention required again for target vessel 
non-target lesion (due to previous non-treatment, 
progression of stenosis, or other reasons, and this lesion is 
unrelated to the target lesion). 
 
Non-target lesion revascularisation (Non-
TLR) 
Revascularisation performed on lesions other than target 
lesions on target vessels 
Non-target vessel revascularisation (Non-
TVR) 
Revascularisation performed on non-target vessel lesions 
Clinically and physiologically indicated 
revascularisation (CPI-Resvasc) 
Revascularisation is considered a clinical indication if 
related to any of the following: 
 
Unplanned 
emergency 
revascularisation 
with 
positive troponin 
 
Positive assessment of invasive functional ischemia 
(e.g., FFR, iFR, Doppler flow velocity reserve) 
 
Positive 
assessment 
of 
ischemia 
based 
on 
angiography (QFR) 
 
Angiographic percent diameter stenosis ≥ 50%, and 

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positive assessment of non-invasive ischemia (e.g., 
dobutamine stress test, radionuclide myocardial 
imaging, exercise test, FFR-CT) 
 
Angiographic percent diameter stenosis ≥ 90%