Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

Study Overview
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Brief Summary
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Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study

Detailed Description
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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.

Official Title
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Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During Endovascular Abdominal Aortic Repair for Infrarenal Abdominal Aortic Aneurysm - Randomized Study

Conditions
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Abdominal Aortic Aneurysm Without Rupture

Intervention / Treatment
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* Device: EVAR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-emptive AAA sac embolization<br> | Device: EVAR<br>* EVAR stent graft and embolization material CE marked.<br>|
| Sham Comparator: No pre-emtive AAA sac embolization<br> | Device: EVAR<br>* EVAR stent graft and embolization material CE marked.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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. 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). | 3 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | Incidence of endoleak type 2 and other endoleak will be noted and analysed. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AAA, Embolization, Endoleak, sac regression