Aortic disease
Conditions
Interventions
Group 1:standard EVAR
Group 2:aneurysm sac embolization with a standard dose of coils and fibrin glue during EVAR
Sponsors
Department of Vascular Surgery, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects are males or non-pregnant females aged >=18 years, and the life expectancy is sufficient to complete all procedures of the study; 2. Diagnosed as infrarenal abdominal aortic aneurysm by CTA before operation; 3. Subjects underwent elective EVAR surgery; 4. Preoperative CTA indicates that the subject has a high risk of type II endoleak after EVAR: the diameter of the inferior mesenteric artery is >= 3mm, or at least 3 pairs of unobstructed lumbar arteries, or at least 2 pairs of unobstructed lumbar arteries and a median sacral artery, or the presence of The diameter of one unobstructed lumbar artery is more than 2mm, or the iliac branch stent needs to be anchored to the external iliac artery during the operation; 5. Informed consent approved by the ethics committee must be provided.
Exclusion criteria
Exclusion criteria: 1. The subject's aneurysm has ruptured; 2. Preoperative CTA indicates that the subject's aneurysm morphology is unconventional: the aneurysm neck length is less than 10mm, or the aneurysm neck is severely angled (the aneurysm neck length is greater than 15mm, the ß angle is greater than 75 degree; the a angle is greater than 60 degree; the aneurysm neck is greater than 60 degree; The length is greater than 10mm, the beta angle is greater than 60 degree or the alpha angle is greater than 45 degree), or the diameter of the tumor neck is greater than 30mm or the cone-shaped tumor neck; 3. Subjects need to perform non-standard EVAR: chimney, window or branch stent needs to be placed; 4. In EVAR, a non-bifurcated stent-graft is placed in the aorta, such as straight stent or main-unilateral iliac artery stent (AUI); 5. The subject is known to be allergic to contrast agents or fibrin glue; 6. Subjects have a history of myocardial infarction, thrombolytic therapy or angina pectoris 2 weeks before enrollment; 7. The subject has suffered a stroke or transient ischemic attack (TIA) within 3 months before surgery; 8. Subject life expectancy < 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence of type II endoleak;maximum aneurysmal diameter; | — |
Secondary
| Measure | Time frame |
|---|---|
| re-interventions rate;limb thrombosis;source of type II endoleak;Acute limb ischemia rate;colon ischemia;occurrence of type I endoleak;occurrence of type III endoleak;surgical related mortality;All-cause mortality;Creatinine;success rate of embolization;spinal cord ischemia;perioperative complications and adverse events;re-intervention due to T2EL;intraoperative allergic reaction; | — |
Countries
China
Contacts
Public ContactWang Tiehao
Sichuan Uniersity West China Hospital
Outcome results
None listed