Unruptured proximal and perirenal abdominal aortic aneurysms
Conditions
Interventions
Experimental group:Implant test device
Sponsors
The First Medical Center of the Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years, gender is not limited; 2. Subjects who are diagnosed with proximal and perirenal abdominal aortic aneurysms and need to reconstruct the blood supply of the superior mesenteric artery and both renal arteries; 3. Have suitable vascular conditions, mainly including: (1) The distance between the upper edge of the tumor and the lower edge of the opening of the superior mesenteric artery is >=4 mm; (2) The angle between the proximal aneurysm neck and the long axis of the aorta proximal to the opening of the superior mesenteric artery is =10 mm; (7) The diameter of the blood vessel at the bifurcation of the abdominal aorta is >=16 mm; (8) The length of the distal anchoring area of the iliac artery is >=15mm; (9) The diameter range of the distal iliac artery anchoring zone is: 8-24mm; (10) Subjects with appropriate femoral artery, iliac artery, and upper extremity artery access can be treated with endoluminal aorta; 4. Subjects who can understand the purpose of the trial, voluntarily participate in this study, the subjects themselves or legal representatives sign the informed consent form, and are willing to complete the follow-up according to the requirements of the program.
Exclusion criteria
Exclusion criteria: 1. Subjects with hemodynamically unstable ruptured abdominal aortic aneurysm, pseudo-aortic aneurysm and dissecting aortic aneurysm; 2. Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue disease); 3. The subject has severe stenosis, calcification and mural thrombus in the proximal anchoring area of the stent; 4. The subject needs to intervene in other vascular lesions (such as coronary artery and carotid artery) during the same operation, and the postoperative drug treatment plan is therefore affected; 5. History of myocardial infarction, TIA or cerebral infarction within the past 3 months; 6. The subject has a history of abdominal aortic surgery or endovascular repair surgery; 7. Subjects with severe liver, kidney, lung, and cardiac dysfunction before surgery [Subjects whose serum creatinine level exceeds 150umol/L; subjects whose alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; subjects with serum total bilirubin (STB) more than 2 times the upper limit of normal; subjects with left ventricular ejection fraction less than 50% indicated by echocardiography]; 8. Subjects with acute systemic infection; 9. Subjects with contraindications to antiplatelet agents and anticoagulants; 10. The subject is allergic to contrast agents, anesthetics, stents and delivery device materials; 11. The subject cannot tolerate anesthesia; 12. The subjects are women who are pregnant or breastfeeding or who cannot contracept during the trial; 13. Subjects with a life expectancy of less than 12 months (such as advanced malignant tumors); 14. The subjects have participated in clinical trials of other drugs or devices during the same period; 15. The investigator determines that the subject's vascular condition affects the revascularization of branch arteries or is combined with other diseases and is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal aortic aneurysm treatment success rate 12 months after surgery; | — |
Countries
China
Contacts
Public ContactGuo Wei
The First Medical Center of the Chinese People's Liberation Army General Hospital
Outcome results
None listed