Clinical Application of a New Technique of Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.
• Patients aged greater than 18 years old and less than 80 years old;
• Patients diagnosed with thoraco-abdominal aortic dissecting aneurysm and at least one of the following conditions should be met:
• a)Maximum aneurysm diameter \>50 mm; b)Increase in diameter by more than 5 mm in recent 6 months c)Symptoms such as abdominal pain and back pain associated with thoracic and abdominal aortic dissecting aneurysm were identified.
• d)Poor morphology of thoracic and abdominal aortic dissecting aneurysm; e)Aortic dissection tears to iliac artery resulting in common iliac artery dissection tumor diameter \>40 mm;
• Anatomic criteria
• a)The diameter of the proximal anchoring area (aorta or implanted graft) ranged from 17\
⁃ 36 mm to ≥25 mm in length; b)Distal anchoring area (aorta or implanted graft): If distal anchoring area is in iliac artery, anchoring area diameter range 7\
⁃ 25 mm, length ≥15 mm; If the distal anchoring area is in the abdominal aorta, the anchoring area has a diameter of 12\
⁃ 36 mm and a length of ≥20 mm; c)There is a normal anchoring area at the distal end of the visceral branch vessel. The diameter range of the anchoring area is 6\
⁃ 13 mm and the length is ≥15 mm.
• d)Normal anchoring zone at distal renal artery, anchoring zone diameter 4.5\
⁃ 9 mm, length ≥15 mm; e)Suitable iliac, femoral, and upper limb arterial access.
• 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;