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AI-enhanced Imaging Analysis to Predict Post-EVAR

Key facts

Who runs it
Centre Hospitalier Universitaire de Nice
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
500 people, planned
Started
1 Jan 2025
Expected to end
1 Jan 2028
Type of study
Observational
Treatments tested
  • Endovascular aortic aneurysm repair (EVAR)
Record updated
19 September 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Pre-operative CTA should be performed maximum 6 months before the intervention,
  • At least one post-operative CTA should be performed between 1 month and 12 months following the intervention,
  • CTA needs to be contrast-enhanced with at least injection at arterial and/or portal time,
  • CTA should have a spacing no more than 1 mm

Who cannot take part

  • previous history of AAA repair,
  • age \< 18 years, - patients with syndromic AAA,
  • patients who underwent open repair or complex EVAR (adjunctive sac embolization procedure, chimney/snorkel or fenestrated-branched endografts),
  • ruptured AAA,
  • patients for whom one pre-operative and at least one post-operative CTA (within 1-year) are not available

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Abdominal aortic aneurysm (AAA), defined as a focal dilatation of the aorta, is a life-threatening condition and has become a serious public health challenge worldwide, associated with high rates of mortality and hospitalization. Endovascular aortic repair (EVAR) requires long-term surveillance by a multidisciplinary team to detect and treat post-operative complications.This international, multicentre, retrospective, observational study aims to use Artificial Intelligence-enhanced imaging analysis for the prediction of post-operative outcomes following EVAR. The primary aim is to identify predictive factors and build prediction models of post-operative outcomes following eligible EVAR. The secondary objective is to investigate morphological aortic changes and remodelling following EVAR .

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Screening for eligible patients will be done by a vascular specialist at each participating centers. Only subjects fulfilling all the inclusion and none of the exclusion criteria will be accepted in the study.

Inclusion criteria from clinical characteristics may encompass the following: - patients who underwent elective EVAR for non-ruptured AAA for the first time, - patients who underwent non-complex EVAR procedure with commercially available endografts with CE mark, - patients with non-syndromic AAA or with non-infective AAA, - patients aged more than 18 years old. Inclusion criteria from CTA characteristics may encompass the following: - patients for whom one pre-operative and at least one post-operative CTA (within 1-year) can be collected in DICOM format. Detailed criteria for eligibility include the following: - Pre-operative CTA should be performed maximum 6 months before the intervention, - At least one post-operative CTA should be performed between 1 month and 12 months following the intervention, - CTA needs to be contrast-enhanced with at least injection at arterial and/or portal time, - CTA should have a spacing no more than 1 mm.Primary outcome will be EVAR-related complications including endoleaks, limb-occlusion and stent-graft migration. Secondary outcomes will include in-hospital length of stay post-intervention, re-interventions (with indication for re-intervention), and deaths (all-cause and aneurysm-related deaths). Outcomes will be investigated within 1 year and at the last follow-up of patients. Morphological changes following EVAR will be analyzed and compared based on pre-operative and post-operative CTA images. Images will be collected and analysed, using the PRAEVAorta 2 software (Nurea). Anatomic features measured include the measurement of aneurysm volume diameters and diameters (including AAA maximum diameter), measurement of intraluminal thrombus and calcifications, proximal and distal aneurysm neck lengths and diameters, suprarenal and infrarenal angulation, distal iliac landing zone length and diameter, and iliac tortuosity index. Based on the measurements, aneurysm sac will be classified into three categories: stable/ shrinkage/ expansion.The study will allow to identify predictive factors and develop predictive models of outcomes following eligible EVAR. By leveraging two approaches (traditional statistical analysis and AI-driven algorithms) and providing AI-enhanced detailed imaging analysis of the morphological characteristics of AAA, this study will allow a better understanding of pre-operative features predictive of the patients' outcomes.

The group in the trial

  • EVAR patient

    Treatment: Endovascular aortic aneurysm repair (EVAR)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
AI-enhanced Imaging Analysis for the Prediction of Post-operative Outcomes Following EVAR
Record updated
19 September 2024