Abdominal Aortic Aneurysm Without Rupture
Conditions
Keywords
AAA, Embolization, Endoleak, sac regression
Brief summary
Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study
Detailed description
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.
Interventions
DEVICEEVAR
EVAR stent graft and embolization material CE marked.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient with 55mm (male) or 50 mm (female) AAA, available for EVAR * \> 18 year old
Exclusion criteria
* Not accept to participate * Ruptured AAA * Outside for instruction for the use EVAR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AAA diameter and volume changes/sac regression during follow-up, measurement on control CT and/or ultrasound after EVAR. | 5 years | 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. |
| AAA diameter and volume changes/sac regression during follow-up, measurement on control CT with automatic volume software program | 3 years | 1. Automatic software measured the maximal AAA diameter in millimetres (mm) on index CT and follow-up control scanning. The same technique and measurement points will be used. Specialised software dedicated to AAA maximal diameter will be used. 2. Automatic software measurement of total volume of AAA in millilitres (ml) on index CT scanning and on control CT scanning. Specialised software will perform measurement and volumetry expressed in millilitres (ml). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc) | 5 years | The type of secondary interventions, incidence, time to secondary intervention, and the outcome will be recorded and analysed. |
| Endoleak type 2 incidence, on control CT and ultrasound scanning | 5 years | Incidence of endoleak type 2 and other endoleak will be noted and analysed. |
Outcome results
None listed