Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03687489
Study type Interventional
Source Lifetech Scientific (Shenzhen) Co., Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date September 30, 2018
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04227054 - Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks N/A
Active, not recruiting NCT03507413 - Metformin Therapy in Non-diabetic AAA Patients Phase 2/Phase 3
Not yet recruiting NCT05756283 - The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair N/A
Not yet recruiting NCT04089241 - Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair N/A
Active, not recruiting NCT02604303 - A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
Terminated NCT02469376 - Evaluation of a New Imagingtechnologie for Thrombosis Phase 1
Terminated NCT01843335 - Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair N/A
Completed NCT02229006 - Sodium Fluoride Imaging of Abdominal Aortic Aneurysms N/A
Completed NCT02224794 - LIFE Study: Least Invasive Fast-Track EVAR
Terminated NCT01425242 - Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension N/A
Completed NCT01118520 - AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK) Phase 2
Completed NCT00746122 - Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair N/A
Completed NCT03952780 - Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Completed NCT00583414 - Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients N/A
Recruiting NCT05864560 - Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
Completed NCT01683084 - Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms Phase 4
Active, not recruiting NCT03180996 - Global Fenestrated Anaconda Clinical sTudy
Completed NCT02493296 - The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
Completed NCT03320408 - Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers
Completed NCT03837704 - Comparison of Abdominal Aortic Aneurysm Growth in Adult Smoking Patients Who Either Switch to IQOS, Continue Smoking, or Quit Smoking. N/A