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Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study
In all 124 patients will be included, 62 in each group.
The first group (62 patients) with pre-emptive AAA sac embolization during EVAR and the control group consisted of 62 patients without pre-emptive AAA sac embolization.
The primary goal is to investigate AAA shrinkage/diameter changes in the pre-emptive embolization group compared with the non-embolization group. Further, to investigate all endoleaks and secondary interventions during the follow-up and any difference between groups and correlation if any with pre-emptive embolization.
Demographic, comorbidities, antiplatelet and anticoagulation drugs, AAA characteristics, patent lumbal and inferior mesenteric artery, intervention characteristics and follow-up data will be recorded and analysed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-emptive AAA sac embolization | Active Comparator |
| |
| No pre-emtive AAA sac embolization | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVAR | Device | EVAR stent graft and embolization material CE marked. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AAA diameter and volume changes/sac regression during follow-up, measurement on control CT and/or ultrasound after EVAR. | Sac regression uses the centerline reconstruction to compare the baseline CT aorta scanning and AAA diameter measurement - maximal AAA diameter in millimetres (mm). Further, total volume measurement in (ml) of AAA and sac changes during the follow-up comparing the index CT scan with control CT or ultrasound scanning. | 5 years |
| AAA diameter and volume changes/sac regression during follow-up, measurement on control CT with automatic volume software program |
| 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc) | The type of secondary interventions, incidence, time to secondary intervention, and the outcome will be recorded and analysed. | 5 years |
| Endoleak type 2 incidence, on control CT and ultrasound scanning |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D057867 | Endoleak |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019106 | Postoperative Hemorrhage |
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Incidence of endoleak type 2 and other endoleak will be noted and analysed. |
| 5 years |
| D006470 |
| Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |