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Not yet recruiting NCT05575570

Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

No phase Interventional Abdominal Aortic Aneurysm Without Rupture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EVAR.
Who it may be relevant to
Registry conditions: Abdominal Aortic Aneurysm Without Rupture. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device EVAR
    EVAR stent graft and embolization material CE marked.

Primary outcome measures

  • AAA diameter and volume changes/sac regression during follow-up, measurement on control CT and/or ultrasound after EVAR. [Time frame: 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]
Secondary outcome measures (2)
  • Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc) [Time frame: 5 years]
  • Endoleak type 2 incidence, on control CT and ultrasound scanning [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05575570 · H-22000209

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗