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

Status: Active, not recruiting
Location: See all (22) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: No
View:

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

⁃ 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.

⁃ 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.

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

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

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

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

Locations
Other Locations
China
Chinese PLA General Hospita
Beijing
The Second Xiangya Hospital of Central South University
Changsha
Xiangya Hospital Central South University
Changsha
The First Affiliated Hospital of Fujian Medical University
Fuzhou
The Frist Affiliated Hospital, Zhejiang University
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Qilu Hospital of Shandong University
Jinan
Shandong Provincial Hospital
Jinan
Frist Affiliated Hospital of Kunming Medical University
Kunming
Yan'an Hospital of Kunming City
Kunming
The Frist Hospital of Lanzhou University
Lanzhou
Liuzhou General Hospital
Liuzhou
The Affiliated Hospital of Southwest Medical University
Luzhou
Jiangsu Province Hospital
Nanjing
The First Affiliated Hospital of Guangxi Medical University
Nanning
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
The Second Hospital of Heibei Medical University
Shijiazhuang
Tianjing Medical University General Hospital
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Renming Hospital of Wuhan University
Wuhan
Xijing Hospital, The Fourth Military Medical University
Xi'an
General Hospital of Ningxia Medical University
Yinchuan
Time Frame
Start Date: September 30, 2018
Estimated Completion Date: March 31, 2025
Participants
Target number of participants: 156
Treatments
Experimental: Intervention arm
Participants will be treated with Abdominal Aortic Aneurysm Stent Graft System
Authors
Wei Guo
Sponsors
Leads: Lifetech Scientific (Shenzhen) Co., Ltd.

This content was sourced from clinicaltrials.gov

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