Comparison of Clinical Outcomes of Intravascular Ultrasound (IVUS) -Guided and Angiography-Guided Primary Percutaneous Intervention (PCI) in Patients With Acute ST Segment Elevated Myocardial Infarction (STEMI)
Conditions: ST Elevation Myocardial Infarction
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Comparison of Long-term Clinical Efficacy of IVUS and Angram Guided PCI in Acute STEMI
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Compare IVUS with angiography ographic Guidance PCI
Long-term clinical efficacy of acute STEMI
Applsor:
The Second Affiliated Hospital
of Zhejiang University Medical
College
Principal
investigator (PI):
Wang Jian ' an
Key
participants:
Jiang Jun, Li Changling, Dong
Center
Laboratory:
The Second Affiliated Hospital
of Zhejiang University Medical
College
Version Number:
Version 1.0
Version Date:
April 15th, 2020
Investigator'ssignature:
________________________

Comparison of Long-term Clinical Efficacy of IVUS and Angram Guided PCI in Acute STEMI
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Directents
COVERFOR........................................................................................................................................... 1
DIRECTORY........................................................................................................................................... 2
SCHEMESUMMARY.............................................................................................................................. 4
RESEARCH FLOWCHART........................................................................................................................7
1、RESEARCH
BACKGROUND..................................................................................................................................... 8
2、RESEARCH
PURPOSE:............................................................................................................................................ 8
3、STUDY
ENDPOINT:.......................................................................................................................................... 8
3.1MAINENDPOINT ..................................................................................................................... 8
3.2SECONDARYENDPOINT ........................................................................................................... 8
4、RESEARCH AND DESIGN................................................................................................................ 8
5、SUBJECT SELECT............................................................................................................................ 9
5.1INCLUSION CRITERIA ............................................................................................................... 9
5.2 ELIMINATION CRITERIA .......................................................................................................... 9
6、RESEARCH METHODS...................................................................................................................10
6.1 TREATMENT ALLOCATION METHOD OF SUBJECTS ...................................................................10
6.2 VISIT PLAN .............................................................................................................................10
6.3 THE DATA COLLECTION PLAN..................................................................................................11
6.4 DRUG TREATMENT ................................................................................................................15
6.5 INTRAVASCULAR ULTRASOUND EXAMINATION ......................................................................15
7, DATA MANAGEMENT......................................................................................................................15
7.1 DATA RECORDS......................................................................................................................16
8, ETHICS AND REGULATORY REQUIREMENTS....................................................................................16
8.1 ETHICAL CONSIDERATIONS............................................................................................................16

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8.2. ETHICS REVIEW...................................................................................................................16
8.3 INFORMED CONSENT FORM.................................................................................................16
8.4 REVISION PLAN....................................................................................................................17
8.5 SCHEME DEVIATION UNDER EMERGENCY CONDITIONS.........................................................17
9、RESEARCH MANAGEMENT
9.1 PROGRAMME COMPLIANCE.................................................................................................17
9.2 SCHEME MODIFICATION.......................................................................................................17
10、DATA
MANAGEMENT.................................................................................................................................17
10.1 DATA COLLECTION AND PROCESSING..................................................................................17
10.2 DATA QUALITY ASSURANCE.................................................................................................17
10.3 RAW DATA MANAGEMENT..................................................................................................18
10.4 DEFLECTION AND SYSTEM ERROR CONTROL........................................................................18
11、STATISTICAL ANALYSIS OF...........................................................................................................18
11.1 STATISTICAL SOFTWARE.......................................................................................................18
11.2 STATISTICAL METHODS........................................................................................................18
11.3 SAMPLE SIZE CALCULATION..................................................................................................19
12、RESULTS RELEASED.....................................................................................................................19

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Scheme Summary
Clinical ison of Intravascular Ultrasound (IVUS) Guided and Angiography
(angiographe) for PCI Acute ST Section Elevated Myocardial infarction (STEMI)
Research
Objective
Comparing the long-term clinical efficacy of IVUS-guided and angiography-
guided PCI in patients with acute STEMI
Test device
IVUS (OpticrossTM catheter)
Control device
NA
Research and
Design
Prospective, randomized, and multi-center observational trials
Number
of
planned subjects
200 Cases
Planned number
of locations
Ten clinical sites
Main endpoint
The primary endpoint was major cardiac adverse events (MACE),
defined as cardiac death, recurrent myocardial infarction (MI, q and
non-q waves), and target vasascularization (TVR) at 12 months.
Secondary
endpoint
The
following
indicators
will
be
evaluated
annually
for
3
years.

MACE(2-3 assessed annually)

Target lesion blood revascularization (TLR)

Target lesion failure (TLF)

Target vascular revascularization (TVR)

Target blood vessel failure (TVF)

Myocardial infarction (Q waves and non-Q waves)

Cardidiac death

Noncardiac death

All-cause of death (cardiac and noncardiac)

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
In-stent
thrombosis
(ARC
classification:
determining
/
possible intrastent thrombosis)
Subsequent
arrangements
Clinical follow-up for 30 days, 6 months, 12 months, 24
months, 36 months
Study duration
At 36 months, the
Antiplatelet
therapy
Guidance according to current guide
Clinical inclusion
criteria

C1. Age> 18

C2. STEMI Attack> 30 min, but <12 h

ST segment elevation of at least 2 consecutive guided ≥1 mm or new
LBBB on the C3. ECG

C4. is willing and able to provide informed consent form
Angiographic
inclusion criteria
The AI1. has at least one coronary artery associated with the
infarction, in which the

Criminal lesion and suitable for stent placement

The reference diameter of criminal vessels is ≥2.5 mm but ≤4 mm

TIMI blood flow score ≤1 in the criminal lesion segment before
guiding the lead to pass
AI2. does not have excessive twists and calcification in criminal lesion
segments that allow stents
Clinical Exclusion
Standards
Patients with CE1. have contraindications to the drugs to be used
during the study
CE2. cardiogenic shock associated with hemodynamic instability
CE3. has bleeding or known coagulation disease
CE4. has a history of cerebrovascular accident (CVA) or transient
ischemic attack (TIA) in the past 6 months, or intracranial tumor,
aneurysm or arteriovenous malformation; or active peptic ulcer or
active
gastrointestinal
(GI)
bleeding
in
the
past
2
months;
or

Comparison of Long-term Clinical Efficacy of IVUS and Angram Guided PCI in Acute STEMI
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scheduled major surgery within 6 weeks; or known platelet count
<100,000 / mm3Or Hb <10g/dL
Planned CE5. surgery that cause deactivation of ADP receptor
antagonist
Other serious CE6. diseases such as cancer may reduce life
expectancy to below 1 year
CE7.
recurrent
myocardial
infarction
within
7
days
after
acute
myocardial infarction
Contrast exclusion
criteria
The AE1. bifurcation lesion does not identify it as a criminal lesion
The AE2. criminal lesion is located in the left aorta
AE3. diffuse lesions associated with unidentifiable criminal lesions
AE4. or stent implantation due to stent thrombosis
AE5. may plan CABG bypass surgery within 30 days
AE6. patients develop renal failure during dialysis
Statistical Methods
Major statistical
assumptions
The IVUS guidance group may have better results than the
angiography guidance, especially in TVR or TLR.
Statistical
analysis
Descriptive statistics (e. g., mean, standard deviation, n, minimum,
maximum), or median (95% CI) (continuous variable), or frequency
tables
(classification
variables),
are
used
to
summarize
their
demographic characteristics, clinical history, laboratory examination,
and risk factors.
We will use Logistic regression to analyze the correlation of plaque
morphology with clinical results both 12 and 36 months after STEMI.
Sample
parameter size
To support the objectives, the sample size of this test will be at least
200 subjects.
Core Laboratory
Core Laboratory data Analysis

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1. Research Background
Intravascular ultrasound (IVUS) has been increasingly used for selective and
emergency
percutaneous
coronary
intervention.
Recent
randomized
controlled
studies, large-scale registration studies, and meta-analysis have demonstrated
significant
advantages
in
reducing
mortality,
myocardial
infarction,
and
target
revascularization
compared
with
separate
angiographic-guided
angiography.
As shown in previous studies [1-5), fewer clinical results on clinical studies
of IVUS guided PCI in acute myocardial infarction (AMI) exist and the results
remain controversial. This study will explore the effects of IVUS-guided PCI
on clinical outcomes in patients with acute ST-segment elevation myocardial
infarction (STEMI).
2. Research Objective
Comparing the long-term clinical efficacy of IVUS and angiography-guided PCI
in dealing with acute STEMI.
3. study endpoint
.13. Main endpoint
The primary endpoint
was major
cardiac
adverse
events (MACE),
defined as
cardiac death at 12 months, recurrent myocardial infarction (MI, Q and non-Q
waves), and target vascular revascularization (TVR).
.23. Secondary endpoint
The following indicators will be evaluated annually for 3 years.

MACE(2-3 assessed annually)

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
Target lesion blood revascularization (TLR)

Target lesion failure (TLF)

Target vascular revascularization (TVR)

Target blood vessel failure (TVF)

Myocardial infarction (Q waves and non-Q waves)

Cardidiac death

Noncardiac death

All-cause of death (cardiac and noncardiac)

In-stent thrombosis (ARC classification: determining / possible intrastent
thrombosis)
4. Research and Design
This study is a prospective, single-center, randomized controlled trial to be
conducted at the Second Affiliated Hospital of Zhejiang University School of
Medicine, with plans to recruit 200 STEMI subjects.
Subjects were randomly assigned to 2 treatment groups in a 1: 1 ratio.
5. Subject Selection
Ten centers plan to include 200 male and female patients over 18 to treat
subjects
according
to
the
Intervention
Guidelines
of
the
American
Heart
Association and the American College of Heart Disease.
The number of subjects recruited each center does not exceed 40% of the total
planned enrollment.
5.1 Inclusion criteria
The 200 subjects who met the inclusion / exclusion criteria will undergo emergency
angiography and the following
Clinical inclusion criteria

C1. Age> 18

C2. STEMI Attack> 30 min, but <12 h

ST segment elevation of at least 2 consecutive guided ≥1 mm or new LBBB on the C3.
ECG

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
C4. is willing and able to provide informed consent form
Angiographic inclusion criteria
The AI1. has at least one coronary artery associated with the infarction, in which the

Criminal lesion and suitable for stent placement

The reference diameter of criminal vessels is ≥2.5 mm but ≤4 mm

TIMI blood flow score ≤1 in the criminal lesion segment before guiding the lead
through
AI2. does not have excessive twists and calcification in criminal lesion segments that
allow stents
5.2 Elimination criteria
Clinical Exclusion Standards
Patients with CE1. have contraindications to the drugs to be used during the study
CE2. cardiogenic shock associated with hemodynamic instability
CE3. has bleeding or known coagulation disease
CE4. has a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
over the past 6 months, or intracranial tumor, aneurysm or arteriovenous malformation;
or active peptic ulcer or active gastrointestinal (GI) bleeding in the past 2 months; or
scheduled major surgery within 6 weeks; or known platelet count <100,000 / mm3Or Hb
<10g/dL
Planned CE5. surgery that cause deactivation of ADP receptor antagonist
Other serious CE6. diseases such as cancer may reduce life expectancy to below 1
year
CE7. recurrent myocardial infarction within 7 days after acute myocardial infarction
Contrast exclusion criteria
The AE1. bifurcation lesion does not identify it as a criminal lesion
The AE2. criminal lesion is located in the left aorta
AE3. diffuse lesions associated with unidentifiable criminal lesions
AE4. or stent implantation due to stent thrombosis

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AE5. may plan CABG bypass surgery within 30 days
AE6. patients develop renal failure during dialysis
6. Research Methods
6.1 Treatment allocation method of subjects
Once the subject has signed a research informed Consent (ICF) approved by the
Ethics Committee (EC), meets all clinical and contrast inclusion criteria and
does not meet the clinical or contrast exclusion criteria, the subject is
considered qualified and may participate in this test. Qualified subjects were
randomized
to
1
of
the
two
treatment groups
at
1:
1:
test
groups
(IVUS
guidance group) or control groups (contrast guidance group).
6.2 Visit Plan
The study visits included subject visits during hospitalization (Visit 1),
during
which
the
subjects
were
enrolled
and
randomized
for
subsequent
treatment. All subjects randomized to trial treatment will be part of the
safety set and will receive clinical evaluation on days 30,6,12,2 and 3 years
after the surgery. Follow-up requires the collection of data required by the
protocol, including accompanying medication, recording any adverse events and
collecting original documents.
The number of visits and duration of the subject may be treated depending on:
(a) When patients are included in the study;
(b) When a clear or possible injury occurs, a decision needs to terminate the
study early;
(C) End the study.
Subject follow-up Program:
· Visit 1 inpatient visit;
· Follow-up for 30 days after Visit 2 surgery;

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· Follow-up for 6 months after Visit 3 surgery;
· Follow-up for 12 months after Visit 4 surgery;
· Follow-up for 2 years after Visit 5 surgery;
· Follow-up for 3 years after Visit 6 surgery;
6.3 The Data Collection Plan
The following page is the observation and evaluation time during the study
(Table 1)
Note:
1.
The vital signs include: body temperature, pulse, breathing, and blood pressure.
2.
Blood routine and biochemical activities include: white blood cells, red blood cells,
platelet count, hemoglobin, liver function (ALT, AST), renal function (urea nitrogen,
creatinine), blood lipid (total cholesterol, LDL cholesterol, high density lipoprotein
cholesterol, triglyceride), blood sugar, etc.
3.
Myocardial injury markers include: CK, CK-MB, TnT/TnI.

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Table 1. Observation and Evaluation Schedule during the Study
Visit:
Visit: #
1
Visit 2:
Visit 3: 3
Visit 4: 4
Visit: 5
Visit 6: 6
Evaluation
Entering
the
Group
Random:
Discharg
e:
30 Days ± 7
Days
6 months ±
30 Days
12 months ±
30 Days
2 Year ±
30 Days
3 years ±
30 Days
Sign an informed
consent form
√
Inclusion and
exclusion
criteria
√
Demographic Data
√
Related medical
history and
surgical history,
coronary heart
disease risk
factors
√
vital signs,
physical
examination,
weight, height
√
Myocardial injury
markers
√
√
12-Guided ECG
√
√
Blood
biochemistry and
blood routine
√
√

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Aditant
medication
√
√
√
√
√
√
√
Coronary
angiography
√
√
Ststent
implantation
√
Adverse events,
serious Aevent
end point related
events
√
√
√
√
√
√
√
√
Postoperative
antiplatelet
therapy
√
√
√
√
√
√

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Visit 1: entry (in hospital)
Written informed consent must be obtained only to determine the eligibility of
the patient's participation in the study. The researchers should inform the
subject that even if the subject agreed to attend the study and signed the
informed consent form, cardiac catheterization may not warrant the study. The
screening records are used to record information about candidates who do not
meet the test selection criteria, including, but not limited to, the screening
failure.
The subject was hospitalized for a planned coronary surgery (CAG or PCI). The
selected CAG shall register and randomly as soon as possible to determine
meeting the entry criteria and before any planned or emergency PCI.
Prior to stenting, the following assessment must be completed to confirm the
clinical qualification criteria: demographic (date of birth, gender), relevant
medical / surgical history, history of smoking, history of family history of
coronary
heart
disease,
targeted
physical
examination,
weight,
height,
medication,
vital
signs
(heart
rate,
supine
blood
pressure),
and
NYHA
classification. Laboratory examination (biochemical and blood routine) and
myocardial biomarkers (creponin I, creponin T and creatine kinase), ECG, etc.
All subjects were required to undergo cardiac catheterization to evaluate the
angiography
inclusion
and
exclusion
criteria.
Only
subjects
who
met
the
clinical and angiography qualification criteria were eligible for the trial.
· Record the antiplatelet and anticoagulant agents.
· Record adverse events and endpoint-related events.
Visit 1: from random post to discharge (in the hospital)
Each subject was assigned a strict sequential registration code by a random
number table, subsequently receiving a research intervention.
Random tasks must be completed before patients receive PCI and require whether
all inclusion / exclusion criteria are met while evaluating patients

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· Compliance and drug use.
· Take a 12-guided ECG at 4 days after surgery or before discharge.
· Record the antiplatelet and anticoagulant agents.
· Record adverse events and endpoint-related events.
Visit 1: discharge (in the hospital)
· Record the antiplatelet and anticoagulant agents.
· Record adverse events and endpoint-related events.
30 Days after Visit2 (Surgery)
All subjects in the group must be evaluated 30 days after stenting. Follow-up
assessments can be conducted either by telephone or at the research center.
The following assessment must be completed at 30-day follow.
·
Adverse events and endpoint-related events to evaluate and collect the
original documents.
· Current antiplatelet drugs. Information on dose changes, interruptions, and
cessation of medication must be recorded.
· Laboratory examination that DSMB considers necessary
6 months after Visit3 ()
All subjects in the group must be evaluated within 6 months after stenting.
Follow-up assessments can be conducted either by telephone or at the research
center.
The
following
assessment
must
be
completed
at
6
months
of
postoperative follow-up.
·
Adverse events and endpoint-related events to evaluate and collect the
original documents.
· Current antiplatelet drugs. Information on dose changes, interruptions, and
cessation of medication must be recorded.
12 months after Visit4 ()
All subjects in the group must receive an angiography evaluation at 12 months
after stenting.

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· Photoast Data
·
Adverse events and endpoint-related events to evaluate and collect the
original documents.
· In addition, the researchers will decide which antiplatelet drugs patients
should receive at the end of their research treatment as part of their ongoing
clinical treatment, and this transition information will be recorded.
· NYHA cardiac function rating
· Under treatment principles, if the patient did not terminate participation
in the study, the 12 months or at the end of the follow-up plan to record the
end point or serious adverse events.
2 years after Visit 5()
All subjects in the group must be evaluated 2 years after stenting. Follow-up
assessments can be conducted either by telephone or at the research center.
The
following
assessment
must
be
completed
at
6
months
of
postoperative
follow-up.
·
Adverse events and endpoint-related events to evaluate and collect the
original documents.
· Current antiplatelet drugs. Information on dose changes, interruptions, and
cessation of medication must be recorded.
Visit 6(, 3 years after surgery)
All subjects in the group must be evaluated 3 years after stenting. Follow-up
assessments can be conducted either by telephone or at the research center.
The
following
assessment
must
be
completed
at
6
months
of
postoperative
follow-up.
·
Adverse events and endpoint-related events to evaluate and collect the
original documents.
· Current antiplatelet drugs. Information on dose changes, interruptions, and
cessation of medication must be recorded.

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Unanticipated follow-up
Additional visits for subject safety, drug dose adjustment and need to be
recorded in the case report table.
Lost visit
Patients who do not follow-up by protocol and revoke informed consent will
repeatedly attempt to contact and determine their life status, the occurrence
of any type of myocardial infarction or stroke. If the subject misses any 2
consecutive
follow-up
and
fails
to
contact
(i.
e.
2
phone
calls,
later
approved letters), the subject will be deemed missed.
6.4 Drug Treatment
According to concurrent guidelines and local routine treatment of subjects.
All subjects recommended aspirin load dose (300 mg), clopidogrel load dose
(300
mg)
or
teago
load
dose
(180
mg)
before
stent
implantation,
and
recommended load dose for at least 6 hours prior to surgery. Perioperative
anticoagulant therapy in all subjects included: general heparin or alternative
anticoagulant (low molecular heparin, bialudine, enoxaparin) and ACT> for 250
seconds during interventional surgery. After stenting, the subject lifelong
aspirin for 75-150 mg per day. Biplex antiplatelet therapy should last for at
least 12 months, with the physician's determination that individual subjects
may require clopidogrel / teagrelo treatment for life.
6.5 Intravascular ultrasound examination
It is recommended that intraoperative intravascular ultrasound is recommended
with a 40 MHz mechanical rotating probe for intravascular ultrasound.
Inoperative IVUS Guidelines
Standardized use of intravascular ultrasound is recommended:
It is recommended to use endovascular ultrasound preoperative, during and
after surgery to guide PCI, with preoperative use of nitroglycerin to prevent
spasm. After full exhaust, fully pass the lesion, automatically retract with

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0.5mm/s speed and record the image to the vessel opening.
Refer to the ULTIMATE study results to optimize the PCI effect under IVUS
guidance:
The IVUS standard standards shall meet the following 3 requirements:
The lumen area of the distal reference vessel with the stent segment MLA
greater than 5.0 mm ², or 90% after 1,;
The patch load within the edge of 2, bracket is less than 50%;
3, has no edge mezzanine deep to mid level more than 3 mm
7. Data Management
The researchers must timely record the research data in accordance with the
instructions provided in the CRF specified in the study programme.
7.1 Data Records
The investigator ensures the accuracy, completeness, and timeliness of the
recorded data, and provides answers to the data queries. Trained researchers
enter the data in the specified CRF data bar directory. Data will be frozen
during audit, editing, and source data validation (SDV) to prevent further
editing. The principal investigator signed the CRF and copies of the CRF will
be archived at the Research Center.
All AE/SAEs s will be recorded in CRF and all subjects ' AEs/SAEs s occurring
after the group are reported until the final visit period.
8. Ethics and Regulatory Requirements
8.1 Ethical considerations
The
investigator
will
ensure
that
this
study
will
follow
the
ethical
principles outlined from the Helsinki Declaration of 1996; the National Ethics
Review (trials) in 2007; and the 2002 international ethical guidelines for

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biomedical research involving human subjects. It was conducted after obtaining
the approval of the Ethics Committee of Zhongshan Hospital Affiliated to Fudan
University.
8.2. Ethics Review
Copies of the test protocol, proposed informed consent, other written subjects
information, and any suggested advertising materials must be submitted to IEC
for written approval. A copy of the IEC written approval of the test protocol
and the informed consent form must be obtained before recruiting subjects to
enter the study and transport of research products.
Upon all subsequent revisions to the test protocol and all modifications to
the
informed
consent
form,
the
investigator
must
submit
and
obtain
IEC
approval
if
necessary.
The
investigator
must
notify
local
procedures
of
deviations or SAE, and intra-stent thrombosis, TVR, MI and death and other SAE
reports obtained from the sponsor.
The investigator is responsible for obtaining annual approval and renewal of
the TEC throughout the study period. Copies of the investigator report and the
IEC renewal documents must be sent to the sponsor.
8.3 Informed consent form
Samples of informed consent will be provided to the investigator for use at
the research center. The informed consent form used shall comply with the Good
Clinical Code (GCP) guidelines of the International Coordination Conference
(ICH),
the
ISO
14155,
Helsinki
Declaration,
and
current
guidelines
for
applicable local regulations / laws.
Before attending the clinical trial, each subject must give written consent
after the study content is fully explained to it in the easily understandable
language
of
the
subject.
The
subject
must
have
the
opportunity
to
raise

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questions and to have satisfactory answers to them. Written informed consent
must be properly recorded by signature and dated by the subject or his legal
representative. If the subject is illiterate, an impartial witness may be
required to sign on behalf of the patient. All subjects will receive a copy of
the
informed
consent
form.
The
consent
process
must
be
recorded
in
the
subject's medical record.
8.4 Revision plan
This Programme must be strictly followed and can be changed only by written
amendments.With
appropriate
approval,
the
revised
test
protocol
will
be
distributed to all program recipients.
8.5 Scheme deviation under emergency conditions
Exit when endovascular ultrasound guided PCI due to acute complications from
ultrasound.
9. Research Management
9.1 Programme Compliance
The study shall be conducted to the approved protocol and
any breach or
deviation shall be documented.
9.2 Scheme modification
After the protocol is approved by the Ethics Committee, if the clinical trial
plan needs to be modified, the revised protocol shall be submitted to ethical
approval,
and
if
the
group,
the
clinical
trial
can
be
continued
after
documents obtaining ethical approval.
10. Data management

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10.1 Data collection and processing
Subject data will be collected over the Internet in a secure electronic data
collection (EDC) system. The principal or associate investigator must ensure
the accuracy and integrity of the recorded data and then provide electronic
signatures on the corresponding eCRF.
10.2 Data quality assurance
Take the necessary control measures to ensure the accuracy and reliability of
the data, including reviewing the clinical programs together with the clinical
units,
and
making
regular
supervisory
visits
by
the
sponsor
or
other
designated supervisors. During the clinical site supervision visit, review the
accuracy and integrity of the case records and original data, and any errors
will be preserved by the clinical unit or supervisor. Beyond this:

Follow-up rate above 95%

The Data Administrator challenges the data

Important indicators for 100% verification

Monitor 100% data of input system SDV.

Review the data and give an audit report before the database is locked.
The case record table (Case Report Form,CRF) and the original research data
are kept by the researchers, and the data management and statistical unit are
responsible for the entry, cleaning, locking library and analysis report of
the data.
10.3 Raw Data management
The investigator will retain all the necessary test documents and original
data in the original form that support the data collected from the study
subjects consistent with the ICH/GCP and SFDA GCP guidelines. Documents must
be retained for at least 5 years after the completion of the clinical trial.
10.4 Deflection and system error control
All subjects who meet the inclusion / exclusion criteria and have signed an

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informed consent form will be eligible for the trial. Continuous compliant
subjects will be included in the study to minimize selection bias. Subjects
were randomly assigned to each treatment group.
11. Statistical analysis
11.1 Statistical software
The research statistical analysis was done using SPSS (version 18.0 or later
and Stata (version 12.0 or later).
11.2 Statistical Methods
Statistical description is given below:
Continuous variables: number of group description examples, number of
missing cases, average, median, standard difference, quartile range, minimum,
and maximum.
Classification variable: Number of missing cases, number of splitting
frequencies, and percentage of the group description.
Statistical
tests:
All
statistical
tests
are
bilateral
tests,
and
P
values less than or equal to 0.05 will be considered to be of statistical
significance. (Unless specifically specified).
Overview of s
tatistical methods: different
analysis methods will be
adopted according to the classification of groups and data characteristics,
see the statistical analysis plan for details. The main statistical analysis
methods include t test, card square test, Fisher accurate probability method,
ANOVA, covariance, Logistic regression, CMH card square and rank and test
methods to compare the differences among different groups.
11.3 Sample size calculation
This study belongs to the pilot study and has no design sample size
calculations.

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12. Research results were published
The
results
will
be
published
in
professional
academic
conferences
and
published in the cardiovascular journal. Publication and author issues will be
determined by the Steering Committee based on the overall participation in the
study (drafting programs, core laboratories, responsibilities, end committee
members, etc.) and the number of the patients included.

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References
1.
Catheterization and Cardiovascular Interventions. 2010;75:86–92.
2.
Am J Cardiol. 2011;108:8 –14.
3.
J Am Coll Cardiol Intv. 2014;7:244–54.
4.
Circ J 2016; 80: 477484
5.
Heart Vessels. 2019;34(4):564-571.