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Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

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ClinicalTrials.gov Identifier: NCT05575570
Recruitment Status : Not yet recruiting
First Posted : October 12, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Stevo Duvnjak, Rigshospitalet, Denmark

Study Description
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Brief Summary:
Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Without Rupture Device: EVAR Not Applicable

Detailed Description:

In all 100 patients will be included, 50 in each group. i The first group with pre-emptive AAA sac embolization during EVAR and the control group consisted of 50 patients without pre-emptive AAA sac embolization and EVAR.

The primary goal is to investigate if the pre-emptive embolization can reduce the endoleak incidence and AAA shrinkage. Further, to investigate all 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During Endovascular Abdominal Aortic Repair for Infrarenal Abdominal Aortic Aneurysm - Randomized Study
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Endoleak type 2 incidence, on control CT and ultrasound scanning. Further aneurysm sac regression [ Time Frame: 3 years ]
    Incidence of endoleak type 2 and other endoleak will be noted and analysed. Sac regression comparing the baseline CT aorta scanning and AAA diameter in mm, with control CT or ultrasound scanning.

  2. AAA diameter, measurement on control and/or ultrasound [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc) [ Time Frame: 3 years ]
    The type of secondary interventions, incidence, time to secondary intervention, and the outcome will be recorded and analysed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Stevo Duvnjak, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT05575570    
Other Study ID Numbers: H-22000209
First Posted: October 12, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Stevo Duvnjak, Rigshospitalet, Denmark:
AAA
Embolization
Endoleak
sac regression
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Rupture
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries