Abdominal Aortic Aneurysm Clinical Trial
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
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.
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.
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