Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.
The study is mainly for patients with thoracoabdominal aortic aneurysms, and all subjects who signed the informed consent and passed the screening will be enrolled. Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system. Patients will be followed up at discharge, 1 month, 6 months, 12 months after the implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGPrimary 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.
Time frame: Within 30 days after procedure
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) .
Time frame: 12 months after procedure.
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)
Time frame: 6 and 12 months postoperatively
type I/III endoleak at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
stent graft migration at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
renovisceral artery patency rate at 6 and 12 months postoperatively
Time frame: 6 and 12 months postoperatively
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reintervention secondary to TAAA progression at 6 months, 12 months, and 2-5 years postoperatively.
Time frame: 6 months, 12 months, and 2-5 years postoperatively.
delivery system-related complications during the procedure and within 30 days postoperatively, including conversion to open surgery, and any hemorrhage, hematoma, or pseudoaneurysm of the arterial access
Time frame: during the procedure and within 30 days postoperatively
all-cause mortality at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
TAAA-related mortality at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
device-related adverse events at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively
severe adverse events resulting in death or serious deterioration of health at 6 months, 12 months, and 2-5 years postoperatively
Time frame: 6 months, 12 months, and 2-5 years postoperatively