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Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System

Primary Purpose

Abdominal Aortic Aneurysm

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Abdominal Aortic Aneurysm Stent Graft System
Sponsored by
Lifetech Scientific (Shenzhen) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Abdominal Aortic Aneurysm Stent Graft System

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Patients aged greater than 18 years old and less than 85 years old, regardless of gender.

    2. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol.

    3. Patients diagnosed with Infrarenal Abdominal Aortic Aneurysm and should meet at least one of the following conditions:

    1. The maximum diameter of abdominal aortic aneurysm ≥50mm in male patients, or the maximum diameter of abdominal aortic aneurysm ≥45mm in female patients.
    2. The maximum diameter of abdominal aortic aneurysm ≥40mm and the diameter increased by more than 5mm in the last 6 months (In this case, the diameter data of abdominal aortic aneurysm should be traceable within 6 months).

    3. The abdominal aortic aneurysm compresses vital organs and causes symptoms (such as abdominal pain, lower back pain, etc.) 4. The range of proximal aneurysm neck diameter of the abdominal aortic aneurysm is between 17mm to 32mm.

      5. The length of the proximal aneurysm neck of abdominal aortic aneurysm≥10mm, and the angle of the proximal aneurysm neck ≤75 °.

      6. The range of the diameter of the iliac artery anchoring area is between 8mm to 22mm.

      7.The length of the iliac artery anchoring area≥15mm.

      8. The patient has a suitable iliac and femoral artery approach.

      Exclusion Criteria:

  • 1. Patients with severe stenosis, calcification, or mural thrombus in the anchoring area of the stent and easily lead to incomplete stent apposition.

    2. Patients with rupture of an abdominal aortic aneurysm or threatened rupture.

    3. Patients with abdominal aortic dissection.

    4. Patients with mycotic or infectious abdominal aortic aneurysms.

    5. Patients with a history of myocardial infarction or unstable angina pectoris for 6 months. Characteristics of unstable angina pectoris: angina symptoms gradually increased, new onset of rest or night angina pectoris or occurrence of angina prolonged.

    6. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months.

    7. Patients with a history of allergy to contrast media, stents and conveyor materials (including nickel and titanium, polyester, PTFE, and nylon polymer materials).

    8. A patient with connective tissue diseases such as Marfan syndrome, Eaton syndrome, or Bessel's disease.

    9. Patients with liver dysfunction: Alanine transaminase (ALT) or Aspartate transaminase (AST) were five times higher than the normal upper limit；serum total bilirubin (STB) was two times higher than the normal upper limit.

    10. Patients with renal dysfunction: Serum creatinine (Cr) was two times higher than the normal upper limit.

    11. Life expectancy is less than one year.

    12. Patients with major organ failure or other serious diseases;

    13. Patients who were not suitable for endovascular treatment, judged by the investigator.

    14. Pregnant or lactating women or women who plan to get pregnant.

    15. The patients participated in other clinical trials and did not come out of the group or withdraw within the first 3 months of the screening period of this trial.

Sites / Locations

  • Chinese PLA General Hospita
  • The First Affiliated Hospital of Fujian Medical University
  • The Frist Hospital of Lanzhou University
  • Liuzhou General Hospital
  • The First Affiliated Hospital of Guangxi Medical University
  • The Second Hospital of Heibei Medical University
  • Renming Hospital of Wuhan University
  • The Second Xiangya Hospital of Central South University
  • Xiangya Hospital Central South University
  • Jiangsu Province Hospital
  • General Hospital of Ningxia Medical University
  • Qilu Hospital of Shandong University
  • Shandong Provincial Hospital
  • Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
  • Xijing Hospital, The Fourth Military Medical University
  • The Affiliated Hospital of Southwest Medical University
  • Tianjing Medical University General Hospital
  • The First Affiliated Hospital of Xinjiang Medical University
  • Frist Affiliated Hospital of Kunming Medical University
  • Yan'an Hospital of Kunming City
  • The Frist Affiliated Hospital, Zhejiang University
  • The Second Affiliated Hospital of Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

Participants will be treated with Abdominal Aortic Aneurysm Stent Graft System

Outcomes

Primary Outcome Measures

The success rate of abdominal aortic aneurysm treatment
A successful abdominal aortic aneurysm treatment is a composite index and refers to the following criteria simultaneously: the immediate technical success (the immediate technical success refers to the delivery system is successfully delivered to a predetermined location, the abdominal aortic stent is successfully deployed, and the transporter can be safely withdrawn from the body). the increase of maximum diameter of abdominal aortic aneurysm at the 12th month after surgery ≤5mm, compared with that before surgery. The displacement of anterior abdominal aortic stent was no more than 10mm at the 12th month after the operation from the location before discharge. No type I or type III leakage requiring additional intervention occurred 12 months after surgery。 No abdominal aortic aneurysm rupture within 12 months after surgery.

Secondary Outcome Measures

The incidence of Major Adverse Event (MAE)
Major Adverse Event (MAE) is defined as all-cause death, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
Incidence of type I or III leakage
Type I leakage is also known as peripheral leakage or graft related leakage, which refers to internal leakage resulting from the inability of stent-type blood vessels to adhere closely to an autologous blood vessel, and the blood flow continues to flow into the aneurysm cavity, including proximal type I and distal type I leakage. Type III leakage refers to leakage caused by the failure of stent-type vessels to bind themselves tightly or the rupture of artificial vessels, and the blood flow continues to flow into the aneurysm cavity.
The incidence of abdominal aortic stent displacement
The displacement refers to the position of abdominal aorta stents of postoperative follow-up are displaced more than 10 mm from the before discharge position.
Operation efficacy - incidence of conversion from abdominal aortic aneurysm treatment to open surgery or secondary surgery
The incidence of conversion from abdominal aortic aneurysm treatment to open surgery or secondary surgery intervention.
The incidence rate of perioperative delivery related complications
Perioperative period refers to intraoperative time to 30 days postoperative. Delivery related complications incidence including he transabdominal surgery caused by intraoperative conveyors, the hemorrhage in the middle iliac artery, the hemorrhage in the femoral artery at the puncture site, the hematoma and the pseudoaneurysm.
The incidence of Acute lower limb ischemia.
The incidence of acute lower limb ischemia.
All-cause mortality
All-cause mortality evaluates at 6 months, 12 months and 2-5 years after surgery
Disease related mortality
Abdominal aortic aneurysm-related mortality evaluates at 6 months, 12 months and 2-5 years after surgery.
Severe adverse events (SAE)
The incidence of severe adverse events (SAE). According to the ISO 14155 SAE refers to led to death, led to serious deterioration in the health of the subject, that either resulted in a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, led to foetal distress, foetal death or a congenital abnormality or birth defect
Device-related adverse effects (AE)
The incidence of the device-related adverse effects (AE), according to the ISO14155, adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.

Full Information

First Posted
September 25, 2018
Last Updated
December 27, 2019
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03687489
Brief Title
Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System
Official Title
Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System for Infrarenal Abdominal Aortic Aneurysm: A Prospective, Multi-center, Objective Performance Criteria Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the infrarenal abdominal aortic aneurysm.
Detailed Description
This clinical trial was conducted in a qualified clinical trial institution. Investigators will use Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. to treat patients with Infrarenal Abdominal Aortic Aneurysm. This is a Prospective, Multi-center, Objective Performance Criteria Clinical Trial. It is expected to submit to the ethics committee of the lead unit for review in March 2018, and complete the implantation of 156 patients in 22 centres nationwide within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively. This trial will evaluate whether the device reached the primary safety endpoint and primary efficacy endpoint through two primary endpoint indicators: the incidence of major adverse events (MAE) within 30 days and the success rate of abdominal aortic aneurysm treatment 12 months after surgery. This trail will evaluate whether the device reached the secondary safety endpoint and primary efficacy endpoint through several secondary endpoint indicators: Perioperative (intraoperative to postoperative 30 days) delivery related complications incidence rate (including the transabdominal surgery caused by intraoperative conveyors, the hemorrhage in the middle iliac artery, the hemorrhage in the femoral artery at the puncture site, the hematoma and the pseudoaneurysm), the incidence of acute lower limb ischemia before discharge and 30 days after surgery, all-cause mortality at 6 months, 12 months and 2-5 years after surgery, abdominal aortic aneurysm-related mortality at 6 months, 12 months and 2-5 years after surgery, the incidence of severe adverse events (SAE) at 6 months, 12 months and 2-5 years after surgery, the incidence of the device-related adverse events (AE) at 6 months, 12 months and 2-5 years after surgery, the incidence of type I or type III leakage at 6 months, 12 months after surgery, the incidence of displacement of Abdominal Aortic Aneurysm Stent at 6 months, 12 months after surgery and the incidence of conversion from abdominal aortic aneurysm treatment to open surgery or secondary surgery intervention at 6 months, 12 months and 2-5 years after surgery. According to the guidelines for clinical trials of aortic stent system, the sponsor will apply for CFDA listing registration after completing a 12-month primary endpoint assessment. According to the guidelines for clinical trials of aortic covered stent system, the sponsor will apply for CFDA listing registration after completing a 12-month primary endpoint assessment, and annually follow-up will be conducted until the fifth year for the long-term efficacy observation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
Abdominal Aortic Aneurysm Stent Graft System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Participants will be treated with Abdominal Aortic Aneurysm Stent Graft System
Intervention Type
Device
Intervention Name(s)
Abdominal Aortic Aneurysm Stent Graft System
Intervention Description
Abdominal aortic bifurcation stent and iliac artery extension stent were preloaded into abdominal aortic bifurcation stent transporter and iliac artery extension stent transporter, respectively. In the operation, the abdominal aorta bifurcation stent and the iliac artery extension stent will be delivered to the corresponding lesion position of the abdominal iliac artery and release. The abdominal aortic bifurcation stent and the iliac artery extension stent will form a whole through docking and thereby reducing the risk of rupture of an infrarenal abdominal aortic aneurysm due to the shock of blood flow.
Primary Outcome Measure Information:
Title
The success rate of abdominal aortic aneurysm treatment
Description
A successful abdominal aortic aneurysm treatment is a composite index and refers to the following criteria simultaneously: the immediate technical success (the immediate technical success refers to the delivery system is successfully delivered to a predetermined location, the abdominal aortic stent is successfully deployed, and the transporter can be safely withdrawn from the body). the increase of maximum diameter of abdominal aortic aneurysm at the 12th month after surgery ≤5mm, compared with that before surgery. The displacement of anterior abdominal aortic stent was no more than 10mm at the 12th month after the operation from the location before discharge. No type I or type III leakage requiring additional intervention occurred 12 months after surgery。 No abdominal aortic aneurysm rupture within 12 months after surgery.
Time Frame
12 months after operation
Secondary Outcome Measure Information:
Title
The incidence of Major Adverse Event (MAE)
Description
Major Adverse Event (MAE) is defined as all-cause death, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
Time Frame
30 days after surgery
Title
Incidence of type I or III leakage
Description
Type I leakage is also known as peripheral leakage or graft related leakage, which refers to internal leakage resulting from the inability of stent-type blood vessels to adhere closely to an autologous blood vessel, and the blood flow continues to flow into the aneurysm cavity, including proximal type I and distal type I leakage. Type III leakage refers to leakage caused by the failure of stent-type vessels to bind themselves tightly or the rupture of artificial vessels, and the blood flow continues to flow into the aneurysm cavity.
Time Frame
6 months, 12 months after surgery
Title
The incidence of abdominal aortic stent displacement
Description
The displacement refers to the position of abdominal aorta stents of postoperative follow-up are displaced more than 10 mm from the before discharge position.
Time Frame
6 months, 12 months after surgery
Title
Operation efficacy - incidence of conversion from abdominal aortic aneurysm treatment to open surgery or secondary surgery
Description
The incidence of conversion from abdominal aortic aneurysm treatment to open surgery or secondary surgery intervention.
Time Frame
6 months, 12 months and 2-5 years after surgery.
Title
The incidence rate of perioperative delivery related complications
Description
Perioperative period refers to intraoperative time to 30 days postoperative. Delivery related complications incidence including he transabdominal surgery caused by intraoperative conveyors, the hemorrhage in the middle iliac artery, the hemorrhage in the femoral artery at the puncture site, the hematoma and the pseudoaneurysm.
Time Frame
intraoperative and postoperative 30 days.
Title
The incidence of Acute lower limb ischemia.
Description
The incidence of acute lower limb ischemia.
Time Frame
Before discharge and 30 days after surgery
Title
All-cause mortality
Description
All-cause mortality evaluates at 6 months, 12 months and 2-5 years after surgery
Time Frame
6 months, 12 months and 2-5 years after surgery
Title
Disease related mortality
Description
Abdominal aortic aneurysm-related mortality evaluates at 6 months, 12 months and 2-5 years after surgery.
Time Frame
6 months, 12 months and 2-5 years after surgery
Title
Severe adverse events (SAE)
Description
The incidence of severe adverse events (SAE). According to the ISO 14155 SAE refers to led to death, led to serious deterioration in the health of the subject, that either resulted in a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, led to foetal distress, foetal death or a congenital abnormality or birth defect
Time Frame
6 months, 12 months and 2-5 years after surgery
Title
Device-related adverse effects (AE)
Description
The incidence of the device-related adverse effects (AE), according to the ISO14155, adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.
Time Frame
6 months, 12 months and 2-5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patients aged greater than 18 years old and less than 85 years old, regardless of gender. 2. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol. 3. Patients diagnosed with Infrarenal Abdominal Aortic Aneurysm and should meet at least one of the following conditions: The maximum diameter of abdominal aortic aneurysm ≥50mm in male patients, or the maximum diameter of abdominal aortic aneurysm ≥45mm in female patients. The maximum diameter of abdominal aortic aneurysm ≥40mm and the diameter increased by more than 5mm in the last 6 months (In this case, the diameter data of abdominal aortic aneurysm should be traceable within 6 months). The abdominal aortic aneurysm compresses vital organs and causes symptoms (such as abdominal pain, lower back pain, etc.) 4. The range of proximal aneurysm neck diameter of the abdominal aortic aneurysm is between 17mm to 32mm. 5. The length of the proximal aneurysm neck of abdominal aortic aneurysm≥10mm, and the angle of the proximal aneurysm neck ≤75 °. 6. The range of the diameter of the iliac artery anchoring area is between 8mm to 22mm. 7.The length of the iliac artery anchoring area≥15mm. 8. The patient has a suitable iliac and femoral artery approach. Exclusion Criteria: 1. Patients with severe stenosis, calcification, or mural thrombus in the anchoring area of the stent and easily lead to incomplete stent apposition. 2. Patients with rupture of an abdominal aortic aneurysm or threatened rupture. 3. Patients with abdominal aortic dissection. 4. Patients with mycotic or infectious abdominal aortic aneurysms. 5. Patients with a history of myocardial infarction or unstable angina pectoris for 6 months. Characteristics of unstable angina pectoris: angina symptoms gradually increased, new onset of rest or night angina pectoris or occurrence of angina prolonged. 6. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months. 7. Patients with a history of allergy to contrast media, stents and conveyor materials (including nickel and titanium, polyester, PTFE, and nylon polymer materials). 8. A patient with connective tissue diseases such as Marfan syndrome, Eaton syndrome, or Bessel's disease. 9. Patients with liver dysfunction: Alanine transaminase (ALT) or Aspartate transaminase (AST) were five times higher than the normal upper limit；serum total bilirubin (STB) was two times higher than the normal upper limit. 10. Patients with renal dysfunction: Serum creatinine (Cr) was two times higher than the normal upper limit. 11. Life expectancy is less than one year. 12. Patients with major organ failure or other serious diseases; 13. Patients who were not suitable for endovascular treatment, judged by the investigator. 14. Pregnant or lactating women or women who plan to get pregnant. 15. The patients participated in other clinical trials and did not come out of the group or withdraw within the first 3 months of the screening period of this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Guo, Professor
Organizational Affiliation
Chinese PLA General Hospita
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospita
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
The Frist Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
Liuzhou General Hospital
City
Liuzhou
State/Province
Guangxi
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
The Second Hospital of Heibei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Renming Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Xijing Hospital, The Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
The Affiliated Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
Country
China
Facility Name
Tianjing Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
Frist Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Yan'an Hospital of Kunming City
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
The Frist Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

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Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System

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