Using artificial intelligence to predict abdominal aortic aneurysm shrinkage after stent placement
Prediction of Abdominal Aortic Aneurysm Shrinkage After Endovascular Repair With Artificial Intelligence
This study is testing whether artificial intelligence can help predict how much an abdominal aortic aneurysm will shrink after patients have a stent placed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rijnstate Hospital Academic / other |
| Locations | 5 sites (Arnhem, Non US/Canada and 4 other locations) |
| Trial ID | NCT06250998 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify factors that contribute to successful treatment outcomes in patients who have undergone elective endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA). The primary objective is to develop a predictive model for the shrinkage of AAA one year post-treatment using artificial intelligence. Eligible patients must have received specific types of endografts and have follow-up imaging available for analysis. The study will analyze preoperative imaging data to enhance understanding of aneurysm remodeling.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone technically successful elective EVAR for unruptured infrarenal AAA.
Not a fit: Patients with ruptured or symptomatic AAA, or those treated with specific types of endografts not included in the study, will not benefit from this research.
Why it matters
Potential benefit: If successful, this study could lead to improved predictions of aneurysm shrinkage, allowing for better patient management and outcomes.
How similar studies have performed: While the use of artificial intelligence in predicting treatment outcomes is a growing field, this specific approach to AAA shrinkage prediction is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years; * Elective, initially technically successful (as described by the ESVS guidelines11), infrarenal EVAR for unruptured infrarenal AAA; * Implanted endograft is a Gore Excluder, Medtronic Endurant, Cook Zenith, Cordis Incraft, Endologix AFX, Jotec E-Tegra, or Vascutek Anaconda endograft; * Follow-up of the AAA of at least one year with imaging of the same modality as the preoperative imaging; * Axial reconstructions of preoperative CT angiography available, preferably in the arterial phase and with 3 mm or smaller slice thickness. Exclusion Criteria: * Patients with ruptured or symptomatic AAA; * Patients that were treated with fenestrated or branched endografts, iliac branched devices, non-CE marked devices within trial setting, other endografts (EVAS cases) or chimney procedures; * Acute procedures; * Reintervention before one year follow-up; * Revision cases after previous open or endovascular aneurysm repair of an AAA;
Where this trial is running
Arnhem, Non US/Canada and 4 other locations
- Rijnstate Hospital — Arnhem, Non US/Canada, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (Recruiting)
- Karolinksa Institutet — Stockholm, Sweden (Not_yet_recruiting)
Study contacts
- Study coordinator: Rianne E van Rijswijk, MSc
- Email: contact@radarconsortium.com
- Phone: 0031880057282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.