abdominal aortic aneurysms
Conditions
Interventions
Experimental group:AegisTM II Abdominal Aortic Overlay Stent System
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Males or non-pregnant females between the ages of 18 and 80 years. 2. Subjects with a diagnosis of subrenal abdominal aortic aneurysm. 3. Subjects with a subrenal aneurysm neck length >= 15 mm and an angle of <= 60 degrees between the aneurysm and the neck of the aneurysm 4. Subjects who, in the judgment of the investigator, are suitable for endoluminal treatment. 5. Subjects who can understand the purpose of the trial, voluntarily participate and sign an informed consent form, and are willing to undergo follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with severe stenosis in the stent anchorage area, or calcification that tends to make it difficult for the overlapping stent to fit the wall; 2. Subjects with ruptured aneurysms; 3. Subjects with infected aneurysms; 4. Subjects with a diagnosis of suprarenal and perirenal aneurysms; 5. Subjects with a clear diagnosis of aortic-related connective tissue disease (e.g., marfan syndrome); 6. Subjects with a clear history of allergy to nickel-titanium alloy materials, contrast agents, etc.; 7. Severe abnormal liver and kidney function (alanine aminotransferase or aspartate aminotransferase 2.5 times above the upper limit of normal and serum creatinine 2 times above the upper limit of normal); 8. Uncontrollable infections, such as bacteremia or toxemia; 9. Subjects with malignancy and a life expectancy of less than 12 months; 10. Subjects who are enrolled in another drug or medical device clinical trial and have not completed the primary study endpoint for that study; 11. Subjects with poor patient compliance who are not expected to be followed up on time; 12. Other circumstances judged by the investigator to be inappropriate for endoluminal therapy, such as lack of suitable vascular access and inability to cooperate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month aneurysm treatment success rate;30-day major adverse event (MAE) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate technology success rate;Aneurysm treatment success rate (year 2-5);Aneurysm diameter and diameter change (30 days, 6 months, years 1-5);All-cause mortality;Aortic aneurysm-related mortality;Incidence of secondary interventions (intraluminal, open);Incidence of aneurysm rupture;Incidence of aneurysm rupture;Incidence of endoleaks;Incidence of device-related adverse events; | — |
Countries
China
Contacts
Public ContactDai Xiangchen
Tianjin Medical University General Hospital
Outcome results
None listed