NCT03686189

Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Aortoiliac Aneurysm
• Iliac Aneurysm

Interventions

Type	Name	Description
DEVICE	Iliac Bifurcation Stent Graft System	Device placement after preoperative preparation. For patients with the aortoiliac aneurysm, the placement of short-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft, or the placement of long-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft are recommended.

Timeline

• Start date: 2015-07-02
• Primary completion: 2018-11-30
• Completion: 2019-01-31
• First posted: 2018-09-26
• Last updated: 2018-09-28

Locations

8 sites across 1 country: China