Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

April 8, 2024 updated by: Stevo Duvnjak, Rigshospitalet, Denmark

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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.
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.
5 years
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).
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 8, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-22000209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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