Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.
18 years old ≤ age ≤ 80 years old;
Diagnosed as thoracoabdominal aortic aneurysm (based on modified Crawford classification and 2019 European Guidelines for the Treatment of Aortic aneurysm) and should meet at least one of the following conditions;
Maximum diameter of thoracoabdominal aortic aneurysm>50mm;
The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;
Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;
Thoracoabdominal aortic dissection;
Mycotic or infectious thoracoabdominal aortic aneurysm;
Patients whose systemic or local infection may increase the risk of intravascular graft infection;
Single group
Multi-Branched Thoracoabdominal Stent Graft System
DevicePatients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .
Primary safety endpoint: The incidence of Major Adverse events (MAE) within 30 days after procedure.
Major Adverse Event (MAE) was defined as all-cause death, liver failure, intestinal necrosis, kidney failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.
Primary efficacy endpoint: Success rate of thoracoabdominal aortic aneurysm treatment 12 months after procedure.
Successful treatment of thoracoabdominal aortic aneurysm is a composite index that needs to meet the following indicators at the same time: Immediate technical success (immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body and no type I/III endoleak), no secondary surgical intervention related to thoracoabdominal aortic aneurysms 12 months after procedure (due to aneurysm rupture, continuous enlargement, stent displacement, type I/III endoleak, branch stenosis/ Second surgery caused by occlusion) .
aneurysmal enlargement at 6 and 12 months postoperatively
aneurysmal enlargement defined as a maximum aortic diameter increase of \> 5 mm relative to preoperative computed tomography angiography (CTA)
type I/III endoleak at 6 and 12 months postoperatively
stent graft migration at 6 and 12 months postoperatively
renovisceral artery patency rate at 6 and 12 months postoperatively
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