A prospective, multi-centre, single-arm clinical trial to evaluate the safety and efficacy of Iliac Bifurcation Stent Graft System.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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.
Beijing Anzhen Hospital, Capital Medical university
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The Second Xiangya Hospital of Central South University
Patency rate of internal iliac artery
Patency rate of internal iliac artery \>=89%
Time frame: 180days postoperative
Technical success rate
After implantation of the stent and observed under common iliac artery angiography, the stent was in the right position and adhered well to the vessel wall, with no leakage.
Time frame: immediate
Clinical success rate
The diameter of the common iliac artery aneurysm was not expanded or expanded less than 3mm.
Time frame: 30 days and 180days postoperative.
The incidence of major Adverse Device Effects (ADEs)
Major Adverse Device Effects including death, myocardial infarction, arterial thrombosis, renal function failure, respiratory failure, paraplegia, stroke, gluteus claudication, colon, spinal cord ischemia necrosis, perineum, iliac artery blockages, external iliac vein blockage, expand common iliac artery aneurysms (increased diameter 3 mm), common iliac artery aneurysms rupture, internal leakage (type I and type III), stent fracture, stent displacement.
Time frame: Before discharge, 30 days and 180 days postoperative。
Device related mortality
Deaths related to the device.
Time frame: Before discharge, 30 days and 180days postoperative.
Secondary interventional surgery
The rate of secondary interventional surgery for complications related to the device
Time frame: Before discharge, 30 days and 180days postoperative.
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Changsha, Hunan, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Frist Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Jiangsu Province Hospital
Nanjing, China