Exploratory Study of Thoracoabdominal Artery Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysms
This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of Thoracoabdominal aortic aneurysms (TAAA).
• Age: 18 to 80 years old;
• Patients diagnosed with a Thoracoabdominal aortic aneurysm (based on the modified Crawford classification and European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms), and should meet at least ONE of the following conditions:
‣ Maximum diameter of TAAA is \>50 mm;
⁃ TAAA diameter increases by more than 5 mm in the past 6 months or by more than 10 mm in the past 1 year;
⁃ Definite symptoms associated with TAAA, such as abdominal pain and back pain.
• Anatomical Criteria
‣ Proximal landing zone (aorta or implanted graft): the diameter ranges from 17 to 36 mm, and length should be ≥25 mm;
⁃ Distal landing zone (aorta or implanted graft): If distal landing zone is in iliac artery, distal landing zone diameter ranges from 7 to 25 mm, and length should be ≥15 mm; If the distal landing zone is in the abdominal aorta, distal landing zone diameter ranges from 12 to 36 mm, and length should be ≥20 mm.
⁃ Visceral branch landing zone: the diameter ranges from 6 to 13 mm, and the length should be ≥15 mm;
⁃ Renal artery landing zone: the diameter ranges from 4.5 to 9 mm, and the length should be ≥15 mm;
⁃ Appropriate iliac, femoral, and upper limb arterial access.
• Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;
• Patients do not want to or cannot wait for the approved alternative