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Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

ConditionAbdominal Aortic Aneurysm Without Rupture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorRigshospitalet, Denmark

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with 55mm (male) or 50 mm (female) AAA, available for EVAR

> 18 year old

Disqualifiers

Not accept to participate

Ruptured AAA

Outside for instruction for the use EVAR

Trial design

Design model

Parallel

Treatments tested in this trial

  • EVAR

    Device

    EVAR stent graft and embolization material CE marked.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Pre-emptive AAA sac embolizationActive comparator 1 intervention
Group B: No pre-emtive AAA sac embolizationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years
2

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).

Time frame
3 years

Secondary outcomes

1

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

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

Time frame
5 years
2

Endoleak type 2 incidence, on control CT and ultrasound scanning

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

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: