Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During Endovascular Abdominal Aortic Repair for Infrarenal Abdominal Aortic Aneurysm - Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 124
- Primary Endpoint
- AAA diameter and volume changes/sac regression during follow-up, measurement on control CT with automatic volume software program
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Pre-emptive AAA sac embolization
Intervention: EVAR (Device)
No pre-emtive AAA sac embolization
Intervention: EVAR (Device)
Outcomes
Primary Outcomes
AAA diameter and volume changes/sac regression during follow-up, measurement on control CT with automatic volume software program
Time Frame: 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.
Time Frame: 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 Outcomes
- Endoleak type 2 incidence, on control CT and ultrasound scanning(5 years)
- Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc)(5 years)
Investigators
Stevo Duvnjak
Principal investigator
Rigshospitalet, Denmark