REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR (EndoVascular Aneurysm Repair) (AI-EVAR-FOLLOW)

July 19, 2023 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux cedex, France, 33076
        • Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient with infrarenal abdominal aortic aneurysms
Patient with infrarenal abdominal aortic aneurysms treated with EVAR
Procedure: CT-Scan
semi-automated analyse by anatomical landmarks with a dedicated fully automated software

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Collection of the different events and complications of the aneurysm post EVAR
Time Frame: Month 1
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
Time Frame: Month 3
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
Time Frame: Month 6
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
Time Frame: Month 12
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
Time Frame: Month 1
Measurement of the aneurysm sac volume in cc on the CT scans available
Month 1
Measurement of aneurysm sac volume evolution
Time Frame: Month 3
Measurement of the aneurysm sac volume in cc on the CT scans available
Month 3
Measurement of aneurysm sac volume evolution
Time Frame: Month 6
Measurement of the aneurysm sac volume in cc on the CT scans available
Month 6
Measurement of aneurysm sac volume evolution
Time Frame: Month 12
Measurement of the aneurysm sac volume in cc on the CT scans available
Month 12
Measurement of morphological neck characteristics
Time Frame: Month 6 before intervention
Measurement of the morphological neck characteristics in mm on the CT scans available
Month 6 before intervention
Measurement of morphological neck characteristics
Time Frame: Month 1
Measurement of the morphological neck characteristics in mm on the CT scans available
Month 1
Measurement of morphological neck characteristics
Time Frame: Month 3
Measurement of the morphological neck characteristics in mm on the CT scans available
Month 3
Measurement of morphological neck characteristics
Time Frame: Month 6
Measurement of the morphological neck characteristics in mm on the CT scans available
Month 6
Measurement of morphological neck characteristics
Time Frame: Month 12
Measurement of the morphological neck characteristics in mm on the CT scans available
Month 12
Measurement of graft migration
Time Frame: 6 months before intervention
Measurement of the graft migration if existing on the CT scans available
6 months before intervention
Measurement of graft migration
Time Frame: Month 1
Measurement of the graft migration if existing on the CT scans available
Month 1
Measurement of graft migration
Time Frame: Month 3
Measurement of the graft migration if existing on the CT scans available
Month 3
Measurement of graft migration
Time Frame: Month 6
Measurement of the graft migration if existing on the CT scans available
Month 6
Measurement of graft migration
Time Frame: Month 12
Measurement of the graft migration if existing on the CT scans available
Month 12
Measurement of length between anatomical points evolution
Time Frame: 6 months before intervention
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
Time Frame: Month 1
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
Time Frame: Month 3
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
Time Frame: Month 6
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
Time Frame: Month 12
Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.
Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time Frame: Month
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
Month
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time Frame: 6 months before intervention
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
6 months before intervention
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time Frame: Month 1
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
Month 1
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time Frame: Month 3
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
Month 3
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time Frame: Month 6
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
Month 6
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time Frame: Month 12
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
Month 12
Repeatability between measures (intra observer variability)
Time Frame: 6 months before intervention
Descriptive analysis of the different measurements by overlaps metric analysis
6 months before intervention
Repeatability between measures (intra observer variability)
Time Frame: Month 1
Descriptive analysis of the different measurements by overlaps metric analysis
Month 1
Repeatability between measures (intra observer variability)
Time Frame: Month 3
Descriptive analysis of the different measurements by overlaps metric analysis
Month 3
Repeatability between measures (intra observer variability)
Time Frame: Month 6
Descriptive analysis of the different measurements by overlaps metric analysis
Month 6
Repeatability between measures (intra observer variability)
Time Frame: Month 12
Descriptive analysis of the different measurements by overlaps metric analysis
Month 12
Average time for segmentation (sec)
Time Frame: 6 months before intervention
The time for segmentation by junior/senior surgeon and software is recorded
6 months before intervention
Average time for segmentation (sec)
Time Frame: Month 1
The time for segmentation by junior/senior surgeon and software is recorded
Month 1
Average time for segmentation (sec)
Time Frame: Month 3
The time for segmentation by junior/senior surgeon and software is recorded
Month 3
Average time for segmentation (sec)
Time Frame: Month 6
The time for segmentation by junior/senior surgeon and software is recorded
Month 6
Average time for segmentation (sec)
Time Frame: Month 12
The time for segmentation by junior/senior surgeon and software is recorded
Month 12
Average time for segmentation in comparison with semi-automated segmentation
Time Frame: 6 months before intervention
Description of the average time between the different techniques.
6 months before intervention
Average time for segmentation in comparison with semi-automated segmentation
Time Frame: Month 1
Description of the average time between the different techniques.
Month 1
Average time for segmentation in comparison with semi-automated segmentation
Time Frame: Month 3
Description of the average time between the different techniques.
Month 3
Average time for segmentation in comparison with semi-automated segmentation
Time Frame: Month 6
Description of the average time between the different techniques.
Month 6
Average time for segmentation in comparison with semi-automated segmentation
Time Frame: Month 12
Description of the average time between the different techniques.
Month 12
Total Volume measurement of AAA
Time Frame: 6 months before intervention

Description of the volume measurement of the AAA with the following items:

  • Volume circulating
  • Intraluminal thrombus volume
  • Calcification volume
6 months before intervention
Total Volume measurement of AAA
Time Frame: Month 1

Description of the volume measurement of the AAA with the following items:

  • Volume circulating
  • Intraluminal thrombus volume
  • Calcification volume
Month 1
Total Volume measurement of AAA
Time Frame: Month 3

Description of the volume measurement of the AAA with the following items:

  • Volume circulating
  • Intraluminal thrombus volume
  • Calcification volume
Month 3
Total Volume measurement of AAA
Time Frame: Month 6

Description of the volume measurement of the AAA with the following items:

  • Volume circulating
  • Intraluminal thrombus volume
  • Calcification volume
Month 6
Total Volume measurement of AAA
Time Frame: Month 12

Description of the volume measurement of the AAA with the following items:

  • Volume circulating
  • Intraluminal thrombus volume
  • Calcification volume
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nurea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric DUCASSE, MD, PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2022/66

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aneurysm Aortic

Clinical Trials on CT-Scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings