Guo's Visceral Arteries Reconstruction :The First in Man Study of G-Branch Multiple Branch Stent Graft System.
Phase: NA
Conditions: Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

New Technology Clinical Application Protocol
Clinical Application of New Technique of Thoracoabdominal Aortic
Stent Graft System
Protocol
NCT Number: 04731636 
Document date: September 11, 2020
Version：V2.1
Protocol ID: TAAA-FIM-001

New Technology Clinical Application Protocol
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Table of Contents
1. Study Background ................................................................... 1
2. Study Design ........................................................................ 2
2.1 Study Purpose ......................................................................2
2.2. Method Selection and Reasons ........................................................2
2.3
Inclusion and Exclusion Criteria ..................................................... 2
2.3
Study Endpoints .................................................................. 4
2.5
Study process ..................................................................... 8
3. Statistical analysis .................................................................. 10
3.1 Sample size calculation...................................................................................................................................................................... 10
3.2 Statistical analysis plan.......................................................................................................................................................................10
4.
Ethical issues and informed consent of clinical trial ..................................... 11

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1. Study Background
Thoracic abdominal aortic aneurysm (thoracoabdominal aortic aneurysm, TAAA)
is an aneurysm-like lesion involving the descending and abdominal aorta. Thoracic
abdominal aortic aneurysm incidence rate accounts for approximately 7-15% of all
aortic aneurysm-like dilated lesions. One epidemiological investigation result showed
an incidence rate of approximately 6-10/100,000 patients per year for thoracic and
abdominal aortic aneurysms and an annual rupture rate of 3.5/100,000 patients[1].
With the increasing surgical treatment of abdominal aortic aneurysms, reports of
perirenal abdominal aortic aneurysms are also growing over the years, accounting for
roughly 8 -20% of abdominal aortic aneurysms.
Thoracic abdominal aortic aneurysms and perirenal abdominal aortic aneurysms
currently face difficulties in clinical treatment methods due to the involvement of
multiple veisceral branching vessels. Traditional treatments include open and hybrid
surgery. Open surgery includes the Etheredge, Debakey, and Debakey-Schumacker
methods,have risks of peroperative bleeding, shock, multiple organ failure etc. due to
its
thoraco-abdorminal
combined
incision,
sizabale
wound,
and
complex
reconstraction of visceral artery.The prognoss of patients undergoing open surgeries is
heavily dependent on the proficiency of surgical technique among operating
surgeons.In order to prevent the potential risks of open surgery and reduce the size of
the incision wound caused by traditional thoracotomy and laparotomy procedures,
many scholars have made corresponding attempts. In 1999, Quiñones-Baldrich et al[3]
first used hybrid surgery for the treatment of TAAA[3]. Even though hybrid surgery
generates less surgical trauma than open surgery, the issues of high mortality and
complications remain unsolved. Simultaneously, due to the increased exposure of
complicated anatomical posterior peritoneal regions, hybridization techniques need to
be performed by experienced vascular surgeons and high level treatment center,
further limiting its clinical application.
In recent years, with the rapid development of endovascular therapy technology,
current major endovaslcular treatments include fenestrated endograft, branched

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endograft, and octopus stents[4-8]. The results of a crossestional study of 2,607 patients
showed perioperative mortality rate of 23.9%, 30.9%, and 10.6%, respectively, and
found that postoperative complications of endovascular therapy (10.5%) were
significantly lower than those of open surgery (33.5%) and hybrid surgery (31.6%). In
Comparison with open surgery and hybrid surgery, endovascular therapy has the
following advantages: (1) minimally invasive surgery, no chest or abdominal incision;
(2) There is no need to block aorta during operation, therefore reduce the occurrence
of complications of visceral ischemia; (3) Reduce blood loss and hospitalization time;
(4) Reduce spinal cord complications and the mid-stent patency rate is good.
Endovascular therapy is being used in the treatment of thoracic abdominal aortic
aneurysms due to its advantages such as small incision wound and low complication
rate. However, the technique of interventional operation and the design of
standardized branch stents are still the focus of the research, and further research is
needed.
2. Study Design
2.1 Study Purpose
To evaluate the feasibility of the thoracic-abdominal aortic stent-graft system for
endovascular treatment of thoracic-abdominal aortic aneurysms and pararenal
abdominal aortic aneurysm.
2.2. Method Selection and Reasons
There are no commercially available stent-graft systems for the effective
endovascular treatment for thoracoabdominal aortic aneurysms and pararenal
abdominal aortic aneurysm in China, so a prospective, single-group feasibility study
is proposed for this study.
2.3
Inclusion and Exclusion Criteria
2.3.1
Inclusion criteria
(1)
Age ≥18 and ≤80 years;
(2)
Patients diagnosed with type Crawford I-V thoracoabdominal aortic
aneurysmsa and pararenal abdominal aortic aneurysm, and should meet at
least one of the following conditions:
a）The maximum diameter of thoracoabdominal aortic aneurysms and

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pararenal abdorminal aortic aneurysm > 50 mm;
b）Rapid growth of sac >5 mm in diameter in the most recent 6 months;
c）Definite symptoms of abdominal pain and low back pain associated with
thoracicabdominal aortic aneurysms.
(3) Patients with four indispensable reno-visceral arteries including superior
mesenteric artery, celiac trunk and bilaterial renal arteries.
(4) Proximal landing zone 20–36 mm in diameter;
(5) Proximal landing zone ≥25 mm in length;
(6) If distal landing zone in abdominal aorta, distal landing zone should be
12-36mm in diameter and ≥15 mm in length.
(7) The visceral vascular branches landing zone 6~13 mm in diameter and ≥15
mm in length;
(8) The renal artery landing zone 4.5~9 mm in diameter and ≥15 mm in length;
(9) Patients who using the abdominal aortic bifurcation stent graft system should
also meet the following criteria:
a. The iliac artery landing zone 7 ~25 mm in diameter;
b. The iliac artery landing zone ≥15 mm in length;
(10) Patients with appropriate iliacofemoral access and at least one patent upper
extremity access;
(11) Patients who can understand the purpose of the trial, volunntarily participate
and sign the informed consent form, and are willing to complete the
follow-up according to the requirements of the protocol;
2.3.2 Exclusion criteria
(1) Ruptured aortic aneurysm in unstable haemodynamic condition;
(2) Aneurysmal aortic dissection;
(3) Infected or mycotic aortic aneurysm;
(4) Requiring simultaneous coverage or embolisation for bilateral internal iliac
arteries;
(5) Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
(6) Diagnosis of acute coronary syndrome within 6 months;
(7) Patients with any transient ischemic attack (TIA) or ischemic stroke within 3
months;
(8) An allergic history for contrast agents, anticoagulants, antiplatelet drugs,
stent graft or materials of delivery system#
(9) Patients with connective tissue diseases;

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(10) Patients with takayasu arteritis;
(11) Patients with serious vital organ dysfunction or other serious disease;
(12) Preoperative liver renal function abnormalities (ALT or AST ≥5 times the
upper limit of normal value), or serum creatinine ≥150 μmol/L;
(13) Severe pulmonary insufficiency who cannot tolerate general anaesthesia;
(14) Severe coagulation dysfunction;
(15) Undergone major surgical or interventionic surgery within 30 days before
surgery;
(16) Patients whose systemic or local infection may increase the risk of
intravascular graft infection;
(17) Planning pregnancy, pregnancy, or breastfeeding;
(18) The patient participated in other clinical trials or not completed or
withdrawn from other clinical trials within the last 3 months at the time of
screening period ;
(19) Life expectancy less than 1 year;
(20) Patients not appropriate for endovascular repair based on the investigators’
clinical judgement.
2.3.3
Exit criteria
All patients should participate in the study voluntarily, and may withdraw
from the study at any time without penalty, and the rights and interests will not be
affected thereby, and the reasons for discontinuing the study may include, but are not
limited to:

Patient voluntary withdrawal

For therapeutic reasons, the investigator may allow the patient to withdraw
from the study without patient’s consent

Patient lost to follow-up

Study Terminated
If the patient meets the above criteria and discontinues participation in the study,
the study completion page of the patient’s case report form should be completed.
2.3
Study Endpoints

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2.4.1
Primary Endpoint
Incidence
rates
of
Major
Adverse
Events
(MAE)
within
30
days
postoperative
Evaluation time: Within 30 days postoperative
Precautions: Major adverse events are defined as all-cause death, liver failure,
intestinal necrosis, splenic infarction, renal infarction, renal failure, cerebral infarction,
paraplegia,
myocardial
infarction,
and
respiratory
failure
within
30
Days
Postoperative. Among them, liver failure is defined as severe liver damage, leading to
serious dysfunction or decompensation of its synthesis, detoxification, excretion and
biotransformation.
Renal
failure
is
defined
as
prolonged
dialysis,
kidney
transplantation, or other fatal outcome. Guidance for respiratory failure significantly
prolongs intubation, tracheotomy, worsening lung function, oxygen dependence, or
other fatal outcome.
2.4.2 Secondary Endpoint
（1）Immediate intraoperative success rate [Intraoperative]
Definitions of Immediate Technical Success: The delivery system is
successfully delivered to the intended location, the thoracoabdominal
aortic stent graft system is successfully deployed, the branch vessels are
successfully reconstructed, and the delivery system can safely withdraw
from the body; No type I or III endoleaks requiring intervention; No
conversion surgery.
（2）Perioperative delivery-related complication rate [intraoperative and
pre-discharge]
Delivery-related complications refer to intraoperative conveyor-related
conversion to laparotomy, bleeding, hematoma, and pseudoaneurysm in the
delivery approach
（3）Aneurysm-related mortality rate [6, 12 months postoperation]
Aneurysm-related death is defined as death caused by a ruptured
aneurysm or by surgery to treat thoracic and abdominal aortic aneurysm,
pararenal abdominal aortic aneurysm.

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（4）Incidence rate of Serious Adverse Events (SAEs) [6, 12 months
postoperation]
Serious adverse events refers to death or serious deterioration of patient
health condition during the clinical trial, including fatal illness or injury,
permanent
impairment
of
body
structure
or
function,hospitalization
or
prolonged hospital stay, and medical or surgical intervention to avoid
permanent impairment of body structure or function; Events that cause to fetal
distress, fetal death, or congenital abnormalities, congenital defects, etc.
（5）Incidence rate of device-related adverse events [6, 12 months
postoperation]
Adverse events refers to adverse medical events that occur during
clinical trial, whether or not related to the investigational medical device.
However,postoperative stress responses, such as fever,constipation, etc., should
be distinguished by the investigator judgment as normal postoperative stress
responses and therefore do not need to be recorded as adverse events.
Device-related adverse events refers to those that are judged by the investigator
to
be
positively
related,
possibly
related,
or
undeterminable
to
the
investigational medical device.
（6）Incidence rate of Type I or Type III endoleaks [6 and 12 months
postoperation]
Type I endoleaks, also known as peri-graft endoleaks or graft-related
endoleaks, refers to
endoleaks formed by the inability of tight-fitting between
the stent blood vessels and autologous blood vessels, resulting in continuous
blood flowinto the aneurysm lumen, including proximal Type I endoleaks and
distal Type I endoleaks. Type III endoleaks refers to the continuous flow of
blood into the aneurysm cavity caused by the inablitiy of the stent blood vessel
to seal its own interface or the rupture of the artificial vessel.
（7）Incidence rate of Thoracic Abdominal Aortic Stent Graft System
Displacement [6, 12 months postoperation]
Stent migration requiring intervention.

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（8）Incidence
rate
of
branch
stent
occlusion
[6,
12
months
postoperation]
The main stent and branch stent were structurally intact, the blood flow in
branch stent was unobstructed, and there was no branch stent occlusion
caused by thrombus.
（9）Incidence rate of conversion of thoracic and abdominal aortic
aneurysms to open surgery or secondary interventional surgery [6, 12
months postoperation]

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2.5
Study process
2.5.1
Flow chart
Flow Chart
Discharge
longer
than
30days
Discharge
within
30days postoperation
Patients with thoracoabdominal aortic aneurysm
Continues
with
V3
V4
V5
V6
Visits
Continues
with
V5 V6 Visits
V5
6-months
postoperation
follow-up
(liver
and
kidney
function, CTA)
Implant Success
Applicable
Implant Failure
Not Applicable
V1
Sign
Inform
Consent
V1
Pre-operative
Screeing
(Incusion/Exclusion,
lab
test,
CTA, ECG)
Screening Failure
V2 Device implantation during
operation
Conversion
to
open
surgery,
remedy
with
other
medical
devices
V3
Pre-discharge/within
30
days postoperation (lab test,
ECG, CTA)
V4
(AE,
concomitant
medications)
V6 12-months postoperation
follow-up
(liver and
kidney
function, CTA)
Study Complete

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2.5.2
Summary of Trial Data Collection
Summary of Trial Data Collection
1. Preoperative (Visit 1): Preoperative laboratory or imaging studies have been performed prior to the informed
consent form and can be used as baseline data
2. Patients requiring staged surgery: 1) Only follow-up visit 3 at the last surgery; 2) Visit 4,5,6 follow-up date
calculated from the date of last procedure
3. If discharged within 30 days after surgery, Visit 4 (telephone follow-up) should be completed within 30 days
after surgery;
Visit Time
Visit
Items
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit6
Pre-operation1
(-30~0d)
Intra-operat
ive
( 0d)
Before
discharge2
30d
Post-operation
2,3
(±3d)
6M±30d
Post-operation
2
12M±30d
Post-operati
on2
Informed Consent
▲
Inclusion
Exclusion Criteria
▲
Demographic Data
▲
Vital Signs
▲
▲
▲
Current Medical
History
▲
Past Medical
History
▲
Family Medical
History
▲
Chest and
abdomen
Examination
▲
Blood routine
4
▲
▲
Urine routine
5
▲
▲
Liver and kidney
function
6
▲
▲
▲
▲
Enzyme tests
7
▲
▲
Pregnancy test
8
▲
12-lead ECG
▲
▲
CTA/MRI
9
▲
▲
▲
▲
DSA
▲
Surgical Record
▲
Adverse Events
▲
▲
▲
▲
▲
▲
Concomitant
Medications
10
▲
▲
▲
▲
▲
▲
Device Defect
▲
▲
▲
▲
▲

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Blood routine test: Hemoglobin content (Hgb), red blood cell count (RBC), white blood cell count (WBC),
neutrophil count (NEUT), platelet count (PLT)
Urine routine test: Urine glucose (GLU), urine protein (PRO), urine red blood cell count (ERY), urine white
blood cell count (LEU)
6.Liver and kidney function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin
(STB), albumin (ALB), creatinine (SCR), urea (Urea), glucose (GLU) (if glucose values are not included in the
liver and kidney function test sheet, the investigator needs to issue a separate test sheet to meet the glucose data
collection)
7.Enzymatic tests: Lactate dehydrogenase (LDH), creatine kinase (CK), creatine kinase isoenzyme (CK-MB)
8. Pregnancy test: Only for unmenopausal women
9.1) Patients with abnormal renal function before discharge, 6 months after operation and 12 months after
operation were examined by MRI; 2) When collecting the image data of this center, the electronic format is
required to be DICOM format, and the distance between each plain scan is recommended to be less than 2 mm.
10. Concomitant medications: Anticoagulants, antiplatelet drugs, antihypertensive drugs, lipid-lowering drugs,
glucose-lowering drugs, antibiotics
3. Statistical analysis
3.1 Sample size calculation
This study is a feasibility study and the total sample size expected to be 15.
3.2 Statistical analysis plan
3.2.1 Enrollment Analysis
(1) Calculate the number of enrolled and completed cases.
(2) List cases and causes of protocol violations.
3.2.2 Baseline data analysis
Descriptive statistics demography and other baseline data.
3.2.3 Primary endpoint analysis
Incidence rate of major adverse events within 30 days postoperative
3.2.4 Secondary endpoint analysis
Immediate
intraoperative
success
rate,
incidence
rate
of
perioperative
delivery-related complications, aneurysm-related mortality rate, incidence rate of
device-related AEs, SAEs, incidence rate of type I or III endoleaks, incidence rate of
stent migration, incidence rate of branch stent occlusion, and incidence rate of open or
secondary interventional procedures were calculated, and trial discontinued due to
adverse events and cases of SAEs were specifically noted.

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4.
Ethical issues and informed consent of clinical trial
Prior to the clinical trial, the investigator needs to submit the study protocol,
informed consent form and other relevant documents to the Medical Ethics
Committee. Clinical trials may not be started until Ethics Committee approval has
been obtained. Any changes to the protocol must be approved by the Ethics
Committee before they can be implemented.
Before each subject is enrolled in this study, it is the responsibility of the
investigator to provide a complete and comprehensive description of the informed
consent form in writing to the subject or the subject’s guardian.
The investigator
should give sufficient time for the subjects to understand the details of the study
before signing. The informed consent form was signed by the investigator and the
subject or the subject’s legal representative. The informed consent form is made in
duplicate, and each party keeps one copy.
Subjects participating in this study will have free access to the Thoracic and
Abdominal Aortic Stent Graft System and study-related examinations during
postoperative
follow-up,
as
well
as
medical
guidance
from
physicians
and
device-related insurance coverage during follow-up.