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NCT Number: NCT05575570

Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study

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Key information

Conditions

Abdominal Aortic Aneurysm Without Rupture Aneurysm Cardiovascular Diseases Endoleak Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVAR

Device

EVAR stent graft and embolization material CE marked.

Primary outcomes

  1. 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.

  2. AAA diameter and volume changes/sac regression during follow-up, measurement on control CT with automatic volume software program

    Time frame: 3 years

    • 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).

Secondary outcomes

  1. Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc)

    Time frame: 5 years

    The type of secondary interventions, incidence, time to secondary intervention, and the outcome will be recorded and analysed.

  2. Endoleak type 2 incidence, on control CT and ultrasound scanning

    Time frame: 5 years

    Incidence of endoleak type 2 and other endoleak will be noted and analysed.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Oct 12, 2022
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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