A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.
The study is mainly for patients with thoraco-abdominal aortic dissecting aneurysm, and all subjects who passed the screening and signed the informed consent will be enrolled. Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent 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
46
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system.
Chinese PLA General Hospita
Beijing, Beijing Municipality, China
RECRUITINGThe Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative
Major Adverse events (MAE) are defined as death related to thoracic and abdominal aortic dissecting aneurysms, stroke, permanent paraplegia, kidney failure, intestinal necrosis, myocardial infarction, respiratory failure, and liver failure.
Time frame: within 30 days postoperative
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