About this trial
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged greater than 18 years old and less than 80 years old;
Anatomic criteria
Patients who understand the purpose of the trial, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;
Disqualifiers
Patients with severe hematoma in aortic wall in proximal anchoring area of stent
Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
Patients with a history of acute coronary syndrome within 6 months; Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture of an unstable atherosclerotic plaque in the coronary artery or erosion secondary to the formation of new blood 4 thrombus, including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, and unstable angina.
Patients with a transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within 3 months;
Trial design
Single group
Treatments tested in this trial
Thoracoabdominal aortic stent system
DevicePatients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system.
Treatment groups
Trial outcomes
Primary outcomes
The 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.
Sponsors and contacts
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