An observational study in Abdominal Aortic Aneurysms (AAA), sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Observational
Abdominal aortic aneurysm, a condition characterised by an increase in the diameter of the aorta, can be treated either surgically or endovascularly. In the latter, an endoprosthesis consisting of a metal spring covered with an impermeable fabric is inserted through an artery and deployed inside the aorta. This new method appears to be less invasive than surgery, but its long-term results are not yet fully understood. As a result, patients who have undergone this treatment are monitored by their surgeon to ensure that there is no endoleak. Several research teams have proposed analysing medical images to predict this risk of endoleak. Doctors are now trying to use artificial intelligence to automate the analysis of these images.
The use of endoprostheses has revolutionized the therapeutic management of patients with thoracic and/or abdominal aortic aneurysms.
In France, the placement of abdominal aortic endoprosthesis (AAE) for treating infrarenal abdominal aortic aneurysm (AAA) follows the recommendations of the French National Authority for Health (HAS) from 2001, updated in 2009 in light of medical device developments and subsequent literature data (2000-2006). It specifically states that: "endovascular treatment is less invasive than surgical treatment, allowing for reduced 30-day morbidity rates for patients eligible for both surgery and endovascular treatment." Endovascular treatment can thus be offered to patients with normal surgical risk and favorable anatomical criteria, alongside surgical treatment, after informing the patient about the benefits and risks of both methods. The vast majority of patients with AAE require regular long-term follow-up, focusing on sac dimension and volume analysis and complication management. All patients must simultaneously receive optimal treatment for their vascular risk factors and comorbidities.
The updated recommendations can be summarized as follows:
Since 2009, the number of endoprosthetic treatments has steadily increased at the expense of open procedures, although a medical-economic evaluation has questioned the efficiency of endovascular technique in patients eligible for both techniques. The long-term benefit in preventing mortality from AAA rupture remains unestablished (the mortality benefit difference is not maintained at 4 years), and even though most patients die from their comorbidities rather than their aneurysm, the first deaths from late rupture (beyond the fifth year of implantation) have appeared in long-term follow-up studies.
Concurrently, these studies have shown that nearly half of treated patients will require one or more additional procedures in subsequent years, and among treated patients:
Endoleak is the most common complication after AAE placement, with incidence varying greatly depending on type and time elapsed since endoprosthesis placement. It is defined by blood circulation between the AAE and the arterial wall of the AAA. Five types of endoleak have been described according to anatomical, chronological, or physiological characteristics:
Several teams have proposed preoperative criteria to predict endoleak risk (preoperative inferior mesenteric artery patency, sac size), but without real evidence. Some teams propose preventive embolizations based on these criteria (pre- or during procedure).
The investigators propose to evaluate whether a machine learning algorithm can predict endoleak risk from initial CT scan images.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 300 is above the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient treated at La Rochelle Hospital Centre for an abdominal aortic aneurysm through endovascular prosthesis implantation
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Exclusion Criteria:
Indications for infrarenal abdominal aortic aneurysm (AAA) treatment with abdominal aortic endoprosthesis (AAE) were : * AAAs with greatest diameter \> 50 mm for women and \> 55 mm for men, or diameter increase of more than 5 mm in six months and 10 mm in 1 year. * A symptomatic or complicated AAA is treated regardless of size. * Despite the absence of conclusive data, a saccular AAA is considered high-risk due to its particular morphology and is proposed for treatment even if its greatest diameter is \< 50 mm.
Procedure: Abdominal aortic endoprosthesis
An endoprosthesis consisting of a metal spring covered with an impermeable fabric is inserted through an artery and deployed inside the aorta.
Number of endoleaks following endograft implantation
Endoleak is the most common complication after AAE placement, with incidence varying greatly depending on type and time elapsed since endoprosthesis placement. It is defined by blood circulation between the AAE and the arterial wall of the AAA. Five types of endoleak have been described according to anatomical, chronological, or physiological characteristics.
Time frame: From AAE placement to the end of the two-year follow-up
Number of embolizations
Minimally invasive treatment that blocks one or more blood vessels or abnormal vascular channels
Time frame: From AAE placement to the end of the two-year follow-up
Sac size
Normal aortic diameter varies with age, sex, and body habitus, but the average diameter of the adult human infrarenal aorta is approximately 2.0 cm. In most adults, an aortic diameter \>3.0 cm is generally considered aneurysmal.
Time frame: Two-year follow-up
Number of serious adverse events
deaths, ruptures, endoleaks, limb occlusions, and reinterventions
Time frame: From AAE placement to the end of the two-year follow-up
Plan to share: Yes — Data will be made available with publication. A Digital Object Identifier will be used and Data will be available at www.recherche.data.gouv.fr
Supporting information: Study protocol
Time frame: Data will be available immediately following publication.
Access criteria: Researchers who provide a methodologically sound proposal will have access to the data.
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