Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System
NCT ID: NCT03687489
Last Updated: 2019-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
156 participants
INTERVENTIONAL
2018-09-30
2025-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention arm
Participants will be treated with Abdominal Aortic Aneurysm Stent Graft System
Abdominal Aortic Aneurysm Stent Graft System
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.
Interventions
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Abdominal Aortic Aneurysm Stent Graft System
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Lifetech Scientific (Shenzhen) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Guo, Professor
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospita
Locations
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Chinese PLA General Hospita
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The Frist Hospital of Lanzhou University
Lanzhou, Gansu, China
Liuzhou General Hospital
Liuzhou, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Second Hospital of Heibei Medical University
Shijiazhuang, Hebei, China
Renming Hospital of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Xijing Hospital, The Fourth Military Medical University
Xi’an, Shanxi, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Tianjing Medical University General Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Frist Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Yan'an Hospital of Kunming City
Kunming, Yunnan, China
The Frist Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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LTAAA-01
Identifier Type: -
Identifier Source: org_study_id