This study is the First in Man Study of WeFlow-JAAA Stent Graft System manufactured by EndoNom Medtech(Hangzhou) Co., Ltd.
This clinical trial was conducted in a qualified clinical trial institution. Investigators will use WeFlow-JAAA Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. to treat patients with juxta renal abdominal aortic aneurysms. This is a Prospective, single-center, first in man study to evaluate the safety and effectiveness of abdominal aorta stent graft system in the treatment of patients with juxta renal abdominal aortic aneurysms. Follow-up will be conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The abdominal aorta stent graft system consists of the abdominal aorta embedded stent system, the abdominal aorta bifurcation stent system and the extended stent system. The abdominal aorta embedded stent has two embedded branch stents and two fenestrations. It can be combined with a peripheral small stent system of appropriate specifications to reconstruct the superior mesenteric artery, bilateral renal arteries and keep the abdominal trunk unobstructed. At the same time, the combination of the abdominal aorta embedded stent, the abdominal aorta bifurcation stent and the extended stent can solve the proximal renal and transrenal abdominal aortic aneurysm lesions with the upper edge of the abdominal aortic aneurysm body and the lower edge of the superior mesenteric artery opening ≥ 5 mm.
Chinese PLA General Hospital
Beijing, China
RECRUITINGPrimary safety endpoint
No major adverse events related to device or surgery within 30 days after surgery : Major adverse events within 30 days after surgery are all-cause death, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe ischemia, or necrosis of lower limbs.
Time frame: 30 days
Primary effective endpoint
Treatment success rate of abdominal aortic aneurysm 12 months after operation.
Time frame: 12 months
Secondary safety endpoint
All-cause mortality, abdominal aortic aneurysm-related mortality, serious adverse events, device-related adverse events: 1. All-cause mortality 30 days, 6 months, 12 months after operation. 2. Abdominal aortic aneurysm related mortality 30 days, 6 months, 12 months after operation. 3. The incidence of serious adverse events 30 days, 6 months, 12 months after operation. 4. The incidence of device-related adverse events 30 days, 6 months, 12 months after operation.
Time frame: 30 days, 6 months, 12 months
Secondary effective endpoint
The incidence of type I or type III endoleak, the incidence of stent graft displacement, the patency rate of branch vessels, the incidence of conversion to open surgery or secondary interventional surgery.
Time frame: 30 days, 6 months, 12 months
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