Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR
1 other identifier
interventional
124
0 countries
N/A
Brief Summary
Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2024
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
ExpectedApril 10, 2024
April 1, 2024
1.2 years
October 4, 2022
April 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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).
3 years
Secondary Outcomes (2)
Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc)
5 years
Endoleak type 2 incidence, on control CT and ultrasound scanning
5 years
Study Arms (2)
Pre-emptive AAA sac embolization
ACTIVE COMPARATORNo pre-emtive AAA sac embolization
SHAM COMPARATORInterventions
EVAR stent graft and embolization material CE marked.
Eligibility Criteria
You may qualify if:
- Patient with 55mm (male) or 50 mm (female) AAA, available for EVAR
- \> 18 year old
You may not qualify if:
- Not accept to participate
- Ruptured AAA
- Outside for instruction for the use EVAR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 4, 2022
First Posted
October 12, 2022
Study Start
November 1, 2024
Primary Completion
January 1, 2026
Study Completion (Estimated)
January 1, 2028
Last Updated
April 10, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share