Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451315
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-31
Brief Title:
REGISTRY on the Implementation of Artificial Intelligence in the Automatic Analysis of Vascular Network Segmentation
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
REGISTRY on the Implementation of Artificial Intelligence in the Automatic Analysis of Vascular Network Segmentation
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IAVASC
Brief Summary:
The team hypothesizes that fully automatic analysis of AAA could provide increased performance decreased duration of segmentation with increased reproducibility and decreased inter and intraobserver variability to detect aortic aneurysmal sac enlargement volumes and diameters and predict the risk of complications during the procedure and during follow-up MAE MACE MALE Stroke compared to standard methods of measurement relying on approximate maximum sac diameter
Detailed Description:
An abdominal aortic aneurysm AAA is an abnormal dilation of the abdominal aortic wall The most catastrophic consequence of AAA increase evolution is aortic rupture which still results in high morbidity and mortality Accurate measurement of AAAs is necessary to predict the risk of rupture during evolution to take adequate decisions to treat or not the patient as well as detect general and technical risk factors and to follow aneurysm sac behavior after endovascular aortic repair EVAR
Despite the widespread use of diameter measurements in clinical trials and its ease of ascertainment in clinical practice for monitoring of AAAs clinical decision-making regarding the timing of aneurysm repair and even surveillance of sac expansion after EVAR several studies have concluded that the diameter may not be reliable as a rupture risk criterion and that it should be replaced by more specifics criteria
Volumetric assessment of the aneurysm is bound to be a better predictor of AAA expansion and risk of rupture Recently there has been considerable progress in segmentation software allowing a semi-automatic calculation of accurate volumes from CTAs However despite ample evidence volumetry has largely remained in the research domain and is still not carried out in most institutions The major reason is that segmentation methods are time-consuming they do not allow co-registration of interval studies and they require dedicated software and skilled technicians which may be difficult to organize
Innovative software PREAVAorta of Nurea company using artificial intelligence with deep learning approaches is able to reconstruct automatically the vascular structures from CT scans As current solutions only reconstruct the lumen Nureas software also segments automatically aneurysms and associated thrombus With this reconstruction the software is able to provide diameters and in particular maximum diameters but also aneurysmal sac volume It is the first solution providing automatic AAA volume and comparative evolution during follow-up In addition the software provides distances between anatomic points calcification volume and measurement evolutions between different time points The software also automatically detects and quantifies calcifications and stenosis on peripheral arteries which is currently evaluated on the same or independent CT scans for predictive factor analysis especially with regard to stroke risk for carotid stenosis and accesses technical difficulties and predictors or MACE Major Adverse Coronary Event or MALE Major Adverse Limb Event for iliac and femoral arteries
Despite the widespread use of diameter measurements in clinical trials and its ease of ascertainment in clinical practice for monitoring of AAAs clinical decision-making regarding the timing of aneurysm repair and even surveillance of sac expansion after EVAR several studies have concluded that the diameter may not be reliable as a rupture risk criterion and that it should be replaced by more specifics criteria
Volumetric assessment of the aneurysm is bound to be a better predictor of AAA expansion and risk of rupture Recently there has been considerable progress in segmentation software allowing a semi-automatic calculation of accurate volumes from CTAs However despite ample evidence volumetry has largely remained in the research domain and is still not carried out in most institutions The major reason is that segmentation methods are time-consuming they do not allow co-registration of interval studies and they require dedicated software and skilled technicians which may be difficult to organize
Innovative software PREAVAorta of Nurea company using artificial intelligence with deep learning approaches is able to reconstruct automatically the vascular structures from CT scans As current solutions only reconstruct the lumen Nureas software also segments automatically aneurysms and associated thrombus With this reconstruction the software is able to provide diameters and in particular maximum diameters but also aneurysmal sac volume It is the first solution providing automatic AAA volume and comparative evolution during follow-up In addition the software provides distances between anatomic points calcification volume and measurement evolutions between different time points The software also automatically detects and quantifies calcifications and stenosis on peripheral arteries which is currently evaluated on the same or independent CT scans for predictive factor analysis especially with regard to stroke risk for carotid stenosis and accesses technical difficulties and predictors or MACE Major Adverse Coronary Event or MALE Major Adverse Limb Event for iliac and femoral arteries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None