Study on Multibranched Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysm
NCT Number: NCT06478576
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Thoracoabdominal Aortic Aneurysm
Interventions: DEVICE: multibranched stent graft system
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 73
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-06-01
Completion Date: 2028-05-30
Locations: Chinese PLA General Hospital, Beijing, China

Summary:
The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)

Primary Outcome Measures: 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, within 30 days postoperative|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)., Intraoperative and 12 months postoperatively
Secondary Outcome Measures: 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., perioperative period (from surgery to 30 days after surgery)|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., 6 months and 12 months postoperatively|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., 6 months and 12 months postoperatively|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., 6 months and 12 months postoperatively|Device-related adverse events at 6 months and 12 months postoperatively, Adverse events refers to an unfavorable medical event that occurs during a clinical trial, regardless of whether it is related to the medical device being tested. However, it should be distinguished from normal postoperative stress reactions, such as fever and constipation. If the researcher determines that they are normal postoperative stress reactions, they do not need to be recorded as adverse events. If the surgeon chooses staged reconstruction due to the subject's medical condition, it does not constitute an adverse event., 6 months and 12 months postoperatively|Incidence rate of aneurysmal enlargement at 6 and 12 months postoperatively, aneurysmal enlargement defined as a maximum aortic diameter increase of \> 5 mm, 6 and 12 months postoperatively|Incidence rate of Type I/III endoleak at 6 and 12 months postoperatively, Type I endoleak, also known as peri-graft endoleak or graft-related endoleak, refers to the leakage caused by the inability of the stent graft to tightly adhere to the autologous vessel, leading to continuous blood flow into the aneurysm sac. This includes proximal and distal Type I endoleaks. Type III endoleak refers to the leakage caused by the inability of the stent graft's own connectors to tightly adhere or the rupture of the artificial vessel, which results in continuous blood flow into the aneurysm sac., 6 and 12 months postoperatively|Incidence rate of Stent graft migration at 6 and 12 months postoperatively, The evaluation criteria are: at the postoperative follow-up nodes, the position shift of the thoracoabdominal aortic covered stent is greater than 10mm compared to before discharge, or the shift causes symptoms or requires intervention., 6 and 12 months postoperatively|The patency rate of the renovisceral artery at 6 and 12 months postoperatively, branch vessel patency is defined as stenosis of ≤50%, 6 and 12 months postoperatively|Incidence of secondary surgical interventions related to the Thoracoabdominal Aortic Aneurysm at 6 and 12 months postoperatively, Notes: Due to the patient's condition, the surgeon's choice of staged reconstruction does not constitute a secondary surgical intervention., 6 and 12 months postoperatively