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Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

Primary Purpose

Abdominal Aortic Aneurysm Without Rupture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EVAR
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm Without Rupture focused on measuring AAA, Embolization, Endoleak, sac regression

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Pre-emptive AAA sac embolization

    No pre-emtive AAA sac embolization

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    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.
    Endoleak type 2 incidence, on control CT and ultrasound scanning
    Incidence of endoleak type 2 and other endoleak will be noted and analysed.

    Full Information

    First Posted
    October 4, 2022
    Last Updated
    September 13, 2023
    Sponsor
    Rigshospitalet, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05575570
    Brief Title
    Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR
    Official Title
    Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During Endovascular Abdominal Aortic Repair for Infrarenal Abdominal Aortic Aneurysm - Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    January 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rigshospitalet, Denmark

    4. Oversight

    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

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Aortic Aneurysm Without Rupture
    Keywords
    AAA, Embolization, Endoleak, sac regression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    124 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pre-emptive AAA sac embolization
    Arm Type
    Active Comparator
    Arm Title
    No pre-emtive AAA sac embolization
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    EVAR
    Intervention Description
    EVAR stent graft and embolization material CE marked.
    Primary Outcome Measure Information:
    Title
    AAA diameter and volume changes/sac regression during follow-up, measurement on control CT and/or ultrasound after EVAR.
    Description
    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
    Title
    AAA diameter and volume changes/sac regression during follow-up, measurement on control CT with automatic volume software program
    Description
    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).
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc)
    Description
    The type of secondary interventions, incidence, time to secondary intervention, and the outcome will be recorded and analysed.
    Time Frame
    5 years
    Title
    Endoleak type 2 incidence, on control CT and ultrasound scanning
    Description
    Incidence of endoleak type 2 and other endoleak will be noted and analysed.
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

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