Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, France
Location status: Recruiting
NCT Number: NCT06884397
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.
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Request Info18 year and older
All sexes
Observational
La Rochelle, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An endoprosthesis consisting of a metal spring covered with an impermeable fabric is inserted through an artery and deployed inside the aorta.
Time frame: From AAE placement to the end of the two-year follow-up
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
Minimally invasive treatment that blocks one or more blood vessels or abnormal vascular channels
Time frame: Two-year follow-up
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: From AAE placement to the end of the two-year follow-up
deaths, ruptures, endoleaks, limb occlusions, and reinterventions
Contact information is provided by the study sponsor or research team.
Groupe Hospitalier de la Rochelle Ré Aunis
Other
Implantation of an Endovascular Prosthesis for the Treatment of Abdominal Aortic Aneurysms: Use of a Machine Learning Model From CT Images to Predict Complications
Acronym: AORTAPREDICT
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