Clinical trial NCT03687489: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal Aortic Aneurysm Stent Graft System
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:
  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.

Primary outcomes:
measure: The success rate of abdominal aortic aneurysm treatment
timeFrame: 12 months after operation
Secondary outcomes:
measure: The incidence of Major Adverse Event (MAE)
timeFrame: 30 days after surgery
measure: Incidence of type I or III leakage
timeFrame: 6 months, 12 months after surgery
measure: The incidence of abdominal aortic stent displacement
timeFrame: 6 months, 12 months after surgery
measure: Operation efficacy - incidence of conversion from abdominal aortic aneurysm treatment to open surgery or secondary surgery
timeFrame: 6 months, 12 months and 2-5 years after surgery.
measure: The incidence rate of perioperative delivery related complications
timeFrame: intraoperative and postoperative 30 days.
measure: The incidence of Acute lower limb ischemia.
timeFrame: Before discharge and 30 days after surgery
measure: All-cause mortality
timeFrame: 6 months, 12 months and 2-5 years after surgery
measure: Disease related mortality
timeFrame: 6 months, 12 months and 2-5 years after surgery
measure: Severe adverse events (SAE)
timeFrame: 6 months, 12 months and 2-5 years after surgery
measure: Device-related adverse effects (AE)
timeFrame: 6 months, 12 months and 2-5 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospita
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Lanzhou
country: China
facility: The Frist Hospital of Lanzhou University
state: Gansu
city: Liuzhou
country: China
facility: Liuzhou General Hospital
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: The Second Hospital of Heibei Medical University
state: Hebei
city: Wuhan
country: China
facility: Renming Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Xi'an
country: China
facility: Xijing Hospital, The Fourth Military Medical University
state: Shanxi
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Tianjin
country: China
facility: Tianjing Medical University General Hospital
state: Tianjin
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Frist Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: Yan'an Hospital of Kunming City
state: Yunnan
city: Hangzhou
country: China
facility: The Frist Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Chinese PLA General Hospita
name: Wei Guo, Professor
role: PRINCIPAL_INVESTIGATOR
References: