The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)
Age ≥18 and ≤80 years;
Maximum diameter of TAAA >50 mm,
Rapid growth of sac >5 mm in diameter in the most recent 6 months, or rapid growth >10 mm in diameter within 1 year
Symptoms related to thoracoabdominal aortic aneurysm, such as clear abdominal pain and back pain.
Ruptured aortic aneurysm in unstable haemodynamic condition;
Aneurysmal aortic dissection;
Infected or mycotic aortic aneurysm;
Patients whose systemic or local infection may increase the risk of intravascular graft infection;
Single group
multibranched stent graft system
DeviceTo evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)
The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative
Major Adverse Event (MAE) was defined as all-cause death, liver failure, intestinal necrosis, kidney failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure
The success rate of thoracic and abdominal aortic aneurysm treatment after 12 months of surgery
Successful treatment of thoracoabdominal aortic aneurysm is a composite endpoint that requires meeting the following indicators at the same time: immediate technical success (immediate technical success refers to the successful delivery of the delivery system to the predetermined position, successful deployment of the system, safe withdrawal of the delivery system from the body, and no type I/III endoleak), and no secondary surgical intervention related to thoracoabdominal aortic aneurysm within 12 months after surgery (secondary surgery caused by aneurysm rupture, continuous enlargement, stent migration, type I/III endoleak, branch vessel stenosis/occlusion).
Delivery system-related complications during perioperative period (from surgery to 30 days after surgery)
The incidence rate of related complications during the perioperative period (from surgery to 30 days after surgery), including intraoperative transition surgeries caused by delivery devices, bleeding, hematoma, and pseudoaneurysm during the delivery access route.
All-cause mortality at 6 months and 12 months postoperatively
All-cause mortality refers to death from any cause that occurs within the follow-up time period.
Mortality Rate Related to Thoracoabdominal Aortic Aneurysm at 6 months and 12 months postoperatively
Mortality related to thoracoabdominal aortic aneurysm refers to death caused by the rupture of the thoracoabdominal aortic aneurysm or surgery for the treatment of the thoracoabdominal aortic aneurysm.
Incidence of severe adverse events at 6 and 12 months postoperatively
A serious adverse event refers to any occurrence during a clinical trial that leads to death or a serious deterioration in health status, including fatal illnesses or injuries, permanent defects in physical structure or function, the need for hospitalization or prolongation of hospital stay, the need for medical or surgical intervention to prevent permanent defects in physical structure or function, or events leading to fetal distress, fetal death, or congenital abnormalities or defects.
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