Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

Not Applicable

Not yet recruiting

• Conditions: Abdominal Aortic Aneurysm Without Rupture
• Interventions: Device: EVAR

• Registration Number: NCT05575570
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-08
• Study First Posted: 2022-10-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Study Start: 2024-11-01
• Primary Completion: 2026-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No pre-emtive AAA sac embolization	EVAR	-
Pre-emptive AAA sac embolization	EVAR	-

Primary Outcome Measures

Name	Time	Method
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).
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.