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Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

Iliac Aneurysm Clinical Trial

Official title:
Safety and Efficacy Study of Iliac Bifurcation Stent Graft System, A Prospective, Multi-centre, Single-Arm Clinical Trial

Clinical Trial Summary

A prospective, multi-centre, single-arm clinical trial to evaluate the safety and efficacy of Iliac Bifurcation Stent Graft System.

Clinical Trial Description

A prospective, multi-center, Single-Arm clinical trial to evaluate the safety and efficacy of endovascular treatment of the aortoiliac aneurysm or the iliac aneurysm by using Iliac Bifurcation Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. According to the requirements of the study, 64 patients preoperatively diagnosed with the aortoiliac aneurysm or the iliac aneurysm will be recruited and be treated by Iliac Bifurcation Stent Graft System under the guidance of aortic aortography. The safety of operations, stability of releasing stent and the accuracy of positioning will be evaluated intraoperatively. The safety and efficacy of aortic endovascular treatment of Iliac Bifurcation Stent Graft System will be observed by postoperative follow up scheduled 30 days and 180 days after the operation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03686189
Study type Interventional
Source Lifetech Scientific (Shenzhen) Co., Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date July 2, 2015
Completion date January 31, 2019
View Details
See also
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