NCT05964348

Brief Summary

The objective of this registry is to find and validate a correlation between morphological indicators such as volume sac evolution, graft migration or length between anatomical landmarks with aneurysm rupture risk or complications such as endoleaks requiring re-intervention… Secondary objectives are the validation of the reproducibility and accuracy of a dedicated fully automated software enabling Abdominal Aortic Aneurysm (AAA) segmentation to measure AAA diameter, volume evolution and growth over time, proximal and distal sealing zones analyze as well as device migration and integrity after EVAR on computed tomography angiography (CTA). This validation is in comparison with semi-automated analyse controlled by physician.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

May 11, 2023

Last Update Submit

July 19, 2023

Conditions

Aneurysm Aortic

Keywords

Abdominal Aortic AneurysmCT scanSemi-automated analysesSoftware

Outcome Measures

Primary Outcomes (23)

  • Collection of the different events and complications of the aneurysm post EVAR

    Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study

    Month 1

  • Collection of the different events and complications of the aneurysm post EVAR

    Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study

    Month 3

  • Collection of the different events and complications of the aneurysm post EVAR

    Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study

    Month 6

  • Collection of the different events and complications of the aneurysm post EVAR

    Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study

    Month 12

  • Measurement of aneurysm sac volume evolution

    Measurement of the aneurysm sac volume in cc on the CT scans available

    Month 1

  • Measurement of aneurysm sac volume evolution

    Measurement of the aneurysm sac volume in cc on the CT scans available

    Month 3

  • Measurement of aneurysm sac volume evolution

    Measurement of the aneurysm sac volume in cc on the CT scans available

    Month 6

  • Measurement of aneurysm sac volume evolution

    Measurement of the aneurysm sac volume in cc on the CT scans available

    Month 12

  • Measurement of morphological neck characteristics

    Measurement of the morphological neck characteristics in mm on the CT scans available

    Month 6 before intervention

  • Measurement of morphological neck characteristics

    Measurement of the morphological neck characteristics in mm on the CT scans available

    Month 1

  • Measurement of morphological neck characteristics

    Measurement of the morphological neck characteristics in mm on the CT scans available

    Month 3

  • Measurement of morphological neck characteristics

    Measurement of the morphological neck characteristics in mm on the CT scans available

    Month 6

  • Measurement of morphological neck characteristics

    Measurement of the morphological neck characteristics in mm on the CT scans available

    Month 12

  • Measurement of graft migration

    Measurement of the graft migration if existing on the CT scans available

    6 months before intervention

  • Measurement of graft migration

    Measurement of the graft migration if existing on the CT scans available

    Month 1

  • Measurement of graft migration

    Measurement of the graft migration if existing on the CT scans available

    Month 3

  • Measurement of graft migration

    Measurement of the graft migration if existing on the CT scans available

    Month 6

  • Measurement of graft migration

    Measurement of the graft migration if existing on the CT scans available

    Month 12

  • Measurement of length between anatomical points evolution

    Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.

    6 months before intervention

  • Measurement of length between anatomical points evolution

    Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.

    Month 1

  • Measurement of length between anatomical points evolution

    Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.

    Month 3

  • Measurement of length between anatomical points evolution

    Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.

    Month 6

  • Measurement of length between anatomical points evolution

    Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.

    Month 12

Secondary Outcomes (26)

  • Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation

    Month

  • Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation

    6 months before intervention

  • Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation

    Month 1

  • Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation

    Month 3

  • Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation

    Month 6

  • +21 more secondary outcomes

Study Arms (1)

Patient with infrarenal abdominal aortic aneurysms

Patient with infrarenal abdominal aortic aneurysms treated with EVAR

Procedure: CT-Scan

Interventions

CT-ScanPROCEDURE

semi-automated analyse by anatomical landmarks with a dedicated fully automated software

Patient with infrarenal abdominal aortic aneurysms

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male or female ≥18 years of age with an Infra-renal Abdominal Aortic Aneurysm treated with endovascular treatment, ≥50mm, or ≥5mm increase in 6 months or surviving Ruptured AAA

You may qualify if:

  • Male or female ≥18 years of age
  • Infra-renal Abdominal Aortic Aneurysm (AAA) treated with EVAR
  • ≥50mm
  • or ≥5mm increase in 6 months
  • or surviving Ruptured AAA
  • legal capacity to make own decisions, informed of the nature of the registry, has signed non opposition form available for set-up and proper implementation of follow-up visits throughout the duration of the registry

You may not qualify if:

  • Advancing Alzheimer's disease or socially dependent patient
  • Opposition to the use of their data for this research
  • Life expectancy supposed to be inferior to 2 years Pregnant female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Aortic AneurysmAortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Eric Ducasse, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2023

First Posted

July 27, 2023

Study Start

April 5, 2023

Primary Completion

August 31, 2023

Study Completion

January 31, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

FR(1)