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Type II EndoleakRADARNCT07783126

Deep-learning Predictors of Abdominal Aortic Aneurysm Enlargement in Type II Endoleaks After Endovascular Aortic Repair: The RADAR Study

An observational study of Type II Endoleak and Abdominal Aortic Aneurysm Enlargement, run by Ente Ospedaliero Cantonale, Bellinzona.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Background and rationale: Abdominal aortic aneurysm (AAA) is a weakening and enlargement of the main artery in the abdomen. Endovascular aneurysm repair (EVAR) is a minimally invasive treatment used to repair an AAA. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Artificial intelligence model analyzing preoperative CT angiography
How many people
1,250 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study includes a retrospective multicenter cohort of approximately 1,250 adult patients (≥18 years) who underwent elective standard EVAR for an intact fusiform infrarenal abdominal aortic aneurysm between 01.01.2015 and 31.12.2025. Patients must have available preoperative and postoperative CT angiography (CTA) scans of sufficient quality and adequate follow-up data. Patients will be excluded if they underwent emergency repair for ruptured aneurysm, had non-fusiform aneurysms, previous aortic interventions, complex EVAR procedures, non-diagnostic imaging, or refused the use of their health data for research where applicable. Patients will be classified according to follow-up findings into three outcome classes: Class 0, no type II endoleak; Class 1, type II endoleak without significant aneurysm sac growth; or Class 2, type II endoleak with significant sac growth or T2EL-related reintervention.

Who may be able to join

  • Age ≥ 18 years at the time of the index procedure.
  • Elective repair of an intact, fusiform, infrarenal abdominal aortic aneurysm (AAA), symptomatic or asymptomatic, with a maximum aneurysm diameter ≥50 mm in women and 55 mm in men, or repaired for symptoms or documented rapid growth (≥5 mm in 6 months or 10 mm in 12 months).
  • Treatment by standard EVAR, defined as implantation of a commercially available bifurcated infrarenal stent-graft with proximal sealing in the infrarenal neck, below the lowermost renal artery, and without any of the following:
  • fenestrated, branched or scallop-modified devices (F/BEVAR);
  • parallel-graft techniques;
  • adjunctive sac or side-branch embolization at or before the index procedure;
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  • endostapling endoanchor devices at the index procedure;
  • endovascular aneurysm sealing systems (e.g. EVAS);
  • proximal or distal extension cuffs placed during or after the index procedure;
  • aorto-uni-iliac configurations and iliac branch devices;
  • Index procedure performed between 1 January 2015 and 31 December 2025 at one of the participating centers, with follow-up data censored at the administrative cut-off date of 31 December 2026.
  • Preoperative arterial-phase CTA available in digital (DICOM) format, acquired ≤ 6 months before the index procedure.
  • Baseline postoperative CTA acquired between 1 and 3 months after the index procedure.
  • All qualifying CTA examinations (preoperative, baseline and follow-up) acquired with a reconstructed slice thickness ≤ 2.5 mm, with anatomical coverage extending at minimum from the celiac trunk to the external iliac arteries, and including an arterial phase and a delayed (venous) phase.
  • Clinical and imaging documentation sufficient to determine the occurrence and clinical course of type II endoleak (primary outcome), including at least one CTA subsequent to the baseline postoperative CTA. Incompleteness of other clinical variables does not preclude inclusion; such variables are recorded as missing and handled according to the prespecified analytical procedures.

Who cannot join

  • Repair for a ruptured AAA, or emergent repair for contained rupture.
  • Aneurysm morphology other than fusiform infrarenal AAA, including saccular aneurysm, penetrating aortic ulcer, pseudoaneurysm, infected aneurysm, aortic dissection
  • Any previous open or endovascular aortic intervention, thoracic or abdominal, including previous hypogastric or inferior mesenteric artery embolization.
  • Non-diagnostic imaging, defined as a CTA with incomplete anatomical coverage, or with beam-hardening, motion or other artifact of sufficient severity to preclude assessment of the aneurysm sac, the stent-graft sealing zones, the patency of sac-feeding branches, or the presence of endoleak, as judged by the reviewing investigator.
  • Documented refusal of consent or documented objection to the research use of health-related data, where applicable. Where the competent ethics committee has granted a waiver of consent (including for deceased or untraceable patients, in Switzerland under Article 34 HRA), such patients are included in accordance with that authorization.
  • Handling of competing endoleak types (analysis-set and censoring rule) The occurrence of a type I, III, IV or V endoleak is not an eligibility criterion but a censoring or competing event, adjudicated as follows.
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  • Patients in whom a type I, III, IV or V endoleak is identified on the baseline (1-3 month) CTA are excluded from the primary analysis.
  • Patients who develop a type I, III, IV or V endoleak during follow-up are censored at the date of that diagnosis, with the exception of a type Ia or Ib endoleak judged to be secondary to sac enlargement of ≥ 5 mm attributable to a pre-existing and documented type II endoleak.
  • This attribution is made by 2 independent specialists (1 vascular surgeon and 1 radiologist) at the treating institution with disagreements resolved by the central core imaging laboratory at EOC.
  • Outcome classification and follow-up requirement (analysis-set rule)
  • The primary outcome is a three-class variable adjudicated over the entire available imaging follow-up. Each patient is assigned to exactly one of the following classes:
  • Class 0 - no type II endoleak: no type II endoleak identified on the baseline (1-3 month) CTA or on any subsequent CTA.
  • Class 1 - type II endoleak without significant sac growth (benign): a type II endoleak documented on the baseline CTA and/or on any follow-up CTA, with a maximum increase in aneurysm diameter of < 5 mm relative to the baseline postoperative CTA throughout the observation period, and without T2EL-related reintervention. A type II endoleak present on the baseline CTA that subsequently resolves spontaneously, without sac growth ≥ 5 mm and without reintervention, is classified in this class and not in Class 0.
  • Class 2 - type II endoleak with significant sac growth (malignant): a type II endoleak associated with an increase in maximum aneurysm diameter ≥ 5 mm relative to the baseline postoperative CTA, or with a T2EL-related reintervention.
  • Because Class 2 requires two sequential events (appearance of the endoleak and subsequent sac growth), whereas Classes 0 and 1 are defined by the sustained absence of an event, the minimum duration of imaging follow-up required for a valid class assignment differs by class. This is a label-ascertainment (outcome-adjudication) requirement, applied to ensure the validity of the reference standard against which the model is evaluated. It is not an eligibility criterion. The minimum follow-up requirement applies only to event-free patients (Classes 0 and 1), whereas patients in whom a Class 2 event has already been documented are assigned to Class 2 irrespective of the total duration of follow-up. It is not applied in an outcome-dependent manner that would preferentially remove patients at higher risk of the outcome. Class 2 (malignant): no minimum duration of follow-up is required. Once sac growth ≥ 5 mm attributable to a type II endoleak, or a T2EL-related reintervention, has been documented, the class assignment is definitive irrespective of the total duration of follow-up. Excluding such patients on the basis of short follow-up would remove confirmed events and would introduce outcome-dependent selection.
  • Class 1 (benign): a minimum of 24 months of imaging follow-up from the baseline postoperative CTA is required, with the last available CTA showing an increase in maximum aneurysm diameter of < 5 mm relative to baseline. Where the endoleak is first detected after the baseline CTA, at least 24 months of imaging follow-up from the date of first detection of the endoleak is additionally required.
  • Class 0 (no endoleak): a minimum of 24 months of imaging follow-up from the baseline postoperative CTA is required, with no type II endoleak identified on any examination and an increase in maximum aneurysm diameter of < 5 mm relative to baseline.
  • Indeterminate: patients who are event-free but who do not meet the minimum follow-up requirement for Class 0 or Class 1 are classified as indeterminate. Indeterminate patients are not assigned a reference class and are excluded from the primary validation analysis. They are retained in the study database, reported in the participant flow diagram, and described in the analysis of the source population.
  • All eligible patients enter the cohort at the baseline (1-3 month) postoperative CTA and are followed until the earliest of: the last available CTA, a T2EL-related secondary intervention, a censoring event as defined in the preceding section, death, or administrative censoring at 31 December 2026. Administrative censoring at 31 December 2026 is a common closing date applied to the entire cohort and not a deadline by which follow-up must already have ended: a patient still under observation on that date contributes person-time up to that date, whereas a patient whose follow-up ends earlier for any of the reasons listed above is censored at the earlier date. The number of patients censored for each reason will be reported.
  • The primary analysis includes all eligible patients with a definitive class assignment (Class 0, 1 or 2) as defined above.
  • Death, rupture or secondary intervention for a cause other than type II endoleak occurring before the minimum follow-up requirement is met are treated as competing events. Such patients are classified as indeterminate unless a Class 2 event has already been documented, in which case the Class 2 assignment stands.
  • The distribution of follow-up duration (median, interquartile range, and proportion below 24 months) will be reported overall and by class.
  • Among Class 2 patients, the cumulative distribution of the interval from the baseline CTA to first detection of the type II endoleak, and from first detection to documented sac growth ≥ 5 mm, will be reported. These distributions provide an empirical justification of the 24-month threshold and an estimate of the residual proportion of late events that the threshold may fail to capture.
  • Prespecified sensitivity analyses will be reported alongside the primary analysis: (i) the minimum follow-up requirement for Classes 0 and 1 varied to 12, 18 and 36 months, with the resulting class counts and model performance reported at each threshold; (ii) an analysis in which indeterminate patients are assigned to Class 0 or Class 1 according to their status at the last available CTA, to quantify the effect of their exclusion; and (iii) an analysis restricted to patients with ≥ 36 months of follow-up.
  • Sac diameter change (in mm, and as annualized change in mm/year) relative to the baseline postoperative CTA will additionally be recorded as a continuous secondary outcome. This permits a threshold-independent assessment of model output and limits the extent to which the dichotomy at 5 mm determines the reported results.
  • Reproducibility of the diameter measurement on which the 5 mm threshold depends will be quantified. A random sample of at least 10% of examinations will be measured independently by two readers, and the intraclass correlation coefficient together with the Bland-Altman limits of agreement for maximum aneurysm diameter will be reported. Cases in which the measured diameter change lies within the limits of agreement of the 5 mm threshold will be identified and examined in a sensitivity analysis.
  • Variables recorded rather than applied as eligibility criteria The following are documented as covariates and are not used to exclude patients, since retrospective adjudication would be unreliable and would preferentially remove patients with hostile anatomy, in whom type II endoleak behavior may differ.
  • Adherence to the device-specific instructions for use (IFU) in force at the time of implantation, assessed retrospectively per device and reported as adherent, non-adherent or indeterminate, together with the specific IFU parameter(s) not met.
  • Antiplatelet and anticoagulant therapy at baseline and during follow-up.
  • Patency, number and diameter of sac-feeding branches (inferior mesenteric artery, lumbar arteries, accessory renal arteries, median sacral artery) on the preoperative CTA.
  • Device manufacturer and model, iliac limb configuration.
  • Sac thrombus volume and morphology, infrarenal neck anatomy, and maximum aneurysm diameter at baseline.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Giorgio Prouse, MD contact

+41 91 811 6328

giorgio.prouse@eoc.ch

Mariacarla Andreozzi, PhD contact

+41 91 811 7361

mariacarla.andreozzi@eoc.ch

About this study

Official title: Deep-learning Prediction of Abdominal Aortic Aneurysm Enlargement in Type II Endoleak After EVAR: Development and Multicenter Validation of an End-to-end Deep-learning Model (the RADAR Study)

Background and rationale:

Abdominal aortic aneurysm (AAA) is a weakening and enlargement of the main artery in the abdomen. Endovascular aneurysm repair (EVAR) is a minimally invasive treatment used to repair an AAA. After EVAR, some patients develop a complication, called a type II endoleak (T2EL), in which blood continues to flow into the aneurysm sac through small blood vessels. Many T2ELs disappear on their own, but in some patients they can cause the aneurysm sac to enlarge and may require another procedure. The RADAR study aims to develop a deep-learning computer model that can use the CT scan performed before EVAR to predict which patients are more likely to develop a T2EL associated with aneurysm enlargement. The model will be developed using information from several hospitals and tested on patients from hospitals that were not involved in its development.

Read more

Duration: July 2026 - December 2028

The study will include patients who have undergone EVAR between 1 January 2015 and 31 December 2025. Their available follow-up information will be collected until 31 December 2026 or until an earlier event such as the last available CT scan, a procedure related to T2EL, another defined medical event, or death. The baseline postoperative CTA, acquired 1-3 months after EVAR, will serve as the reference examination for assessment of aneurysm-sac growth during follow-up. Patients who have not developed the study outcome generally need at least 24 months of imaging follow-up to be classified reliably.

Objectives:

The primary objective is to develop and test a deep-learning model that can predict, before EVAR, whether a patient will develop a T2EL and whether it will be associated with significant enlargement of the aneurysm sac. The model will be tested using data from hospitals that were not involved in its development. Secondary objectives are to assess whether the model works consistently across different hospitals and CT scanning methods; compare the new model with the original NornirNet model; determine whether adding clinical and anatomical information improves the predictions; assess differences in performance between hospitals; and evaluate how well the model's predicted risks correspond to the outcomes actually observed.

Study population:

The study is a multicenter observational study involving patients over the age of 18 who underwent elective EVAR for an intact fusiform abdominal aortic aneurysm at participating hospitals in Switzerland, Europe, and the United States between 2015 and 2025. Patients must have suitable CT scans before and after EVAR and sufficient medical and imaging information to determine whether a T2EL occurred and how the aneurysm changed over time. Patients treated for a ruptured aneurysm, patients with certain other types of aneurysms, patients who had previous aortic procedures, and patients whose CT scans are not suitable for analysis will be excluded. The planned study population is approximately 1,250 patients, depending on the number of eligible patients available at the participating hospitals.

Study procedures:

This is a retrospective study, meaning that it uses information and CT scans that were already collected as part of routine medical care. No additional examinations or procedures are performed for the study, and no biological samples are collected. Participating hospitals will provide coded clinical information and anonymized CT scans. The information collected may include age, sex, other medical conditions, body weight and height, laboratory results, heart-related information, details about the aneurysm and blood vessels, and information about the EVAR procedure. Follow-up CT scans will be reviewed by specialists to determine whether a T2EL occurred and whether the aneurysm sac became larger. Patients will be classified into three groups: those with no T2EL, those with a T2EL without significant aneurysm enlargement, and those with a T2EL associated with aneurysm enlargement of at least 5 mm or a related additional procedure. The deep-learning model will be developed using data from some participating hospitals and then tested on data from other hospitals that were not involved in developing the model. Its ability to make accurate and consistent predictions will then be evaluated.

Read the detailed description

RADAR is a retrospective multicenter observational study designed to develop and independently evaluate a three-dimensional deep-learning model for preoperative prediction of clinically relevant type II endoleak (T2EL) after endovascular aneurysm repair (EVAR).

The model will be developed using preoperative CTA data from designated development centers. Model fitting, hyperparameter tuning, and selection of operating thresholds will be performed exclusively within these centers using center-aware cross-validation. After completion of development, the model architecture, parameters, and operating thresholds will be frozen before evaluation on independent held-out test centers. Data from these centers will not be used for model development, tuning, or threshold selection.

The primary analysis will assess the ability of the frozen model to distinguish three predefined clinical outcome classes based on the occurrence of T2EL and subsequent aneurysm-sac behavior. This center-level separation between development and testing is intended to provide an estimate of model performance and generalizability across institutions and heterogeneous imaging protocols.

Secondary analyses will assess inter-center variability in performance, model calibration, and the incremental predictive value of clinical and anatomical variables. The newly developed model will also be compared with the original NornirNet model on a separate common dataset reserved specifically for this comparison.

Being tested
Artificial intelligence model analyzing preoperative CT angiography
Keywords
type II endoleak, abdominal aortic aneurysm, AI, cardiovascular surgery, aorta, radiology, RADAR, EVAR, CT, CTA, T2ELs, sac enlargement, endograft, quantitative features
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial intelligence model analyzing preoperative CT angiographyOther

    This study involves the retrospective multicenter analysis of preoperative CT angiography (CTA) and clinical data from patients who underwent EVAR. A new and improved three-dimensional deep-learning model, building on the NornirNet framework, will be developed using data from designated development centers and subsequently evaluated, after model freezing, on independent held-out centers.

Study groups in NCT07783126
Study groupRoleWhat they receive
Retrospective multicenter EVAR cohortThis retrospective multicenter observational cohort includes adult patients who underwent elective standard EVAR for an intact fusiform infrarenal abdominal aortic aneurysm between 01.01.2015 and 31.12.2025 at participating centers. Eligible patients are identified according to predefined inclusion and exclusion criteria. Based on imaging follow-up, patients with sufficient information for outcome adjudication are assigned to one of three classes: Class 0, no type II endoleak (T2EL); Class 1, T2EL without significant aneurysm sac growth; or Class 2, T2EL associated with significant sac growth or T2EL-related reintervention. Eligible patients with insufficient follow-up for reliable outcome-class assignment are classified as indeterminate, retained in the study database, and excluded from the primary analysis.
Receives: Other: Artificial intelligence model analyzing preoperative CT angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance of the deep-learning model in held-out test centers

    Performance of the frozen deep-learning model will be evaluated in independent held-out test centers for three-class prediction of T2EL outcome: Class 0 (no T2EL), Class 1 (T2EL without significant aneurysm sac growth), and Class 2 (T2EL with significant sac growth or T2EL-related reintervention). Discrimination and classification performance will be assessed using prespecified performance metrics, including AUC, sensitivity, and specificity.

    Measured: From the baseline postoperative CTA (1-3 months after EVAR) through the last available follow-up, T2EL-related reintervention, censoring event, death, or administrative censoring on 31 December 2026.

Secondary outcomes (8)

  1. AUC comparison of the deep-learning models

    Comparison of the newly developed deep-learning model with the original NornirNet model on the reserved common comparison dataset using the area under the receiver operating characteristic curve (AUC).

    Measured: From the baseline postoperative CTA (1-3 months after EVAR) through the last available follow-up, T2EL-related reintervention, censoring event, death, or administrative censoring on 31 December 2026.

  2. Sensitivity comparison of the deep-learning models

    Comparison of the newly developed deep-learning model with the original NornirNet model on the reserved common comparison dataset using sensitivity.

    Measured: From the baseline postoperative CTA (1-3 months after EVAR) through the last available follow-up, T2EL-related reintervention, censoring event, death, or administrative censoring on 31 December 2026.

  3. Specificity comparison of the deep-learning models

    Comparison of the newly developed deep-learning model with the original NornirNet model on the reserved common comparison dataset using specificity.

    Measured: From the baseline postoperative CTA (1-3 months after EVAR) through the last available follow-up, T2EL-related reintervention, censoring event, death, or administrative censoring on 31 December 2026.

  4. Inter-center variability in AUC

    Assessment of inter-center variability in model performance across held-out test centers using the area under the receiver operating characteristic curve (AUC).

    Measured: From the baseline postoperative CTA (1-3 months after EVAR) through the last available follow-up, T2EL-related reintervention, censoring event, death, or administrative censoring on 31 December 2026.

  5. Inter-center variability in specificity

    Assessment of inter-center variability in model performance across held-out test centers using specificity.

    Measured: From the baseline postoperative CTA (1-3 months after EVAR) through the last available follow-up, T2EL-related reintervention, censoring event, death, or administrative censoring on 31 December 2026.

  6. Change in AUC with clinical and anatomical variables

    Assessment of the incremental predictive value of clinical and anatomical variables using change in the area under the receiver operating characteristic curve (AUC).

    Measured: From the baseline postoperative CTA (1-3 months after EVAR) through the last available follow-up, T2EL-related reintervention, censoring event, death, or administrative censoring on 31 December 2026.

  7. Net Benefit with clinical and anatomical variables

    Assessment of the incremental predictive value of clinical and anatomical variables using Decision Curve Analysis (Net Benefit).

    Measured: From the baseline postoperative CTA (1-3 months after EVAR) through the last available follow-up, T2EL-related reintervention, censoring event, death, or administrative censoring on 31 December 2026.

  8. Brier score for model calibration

    Assessment of model calibration using the Brier score.

    Measured: From the baseline postoperative CTA (1-3 months after EVAR) through the last available follow-up, T2EL-related reintervention, censoring event, death, or administrative censoring on 31 December 2026.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07783126
Sponsor's protocol ID
2026-06264
Acronym
RADAR
Status last verified
Sep 2026
First submitted
20 Aug 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data generated and analyzed during this study will not be publicly available due to privacy and data protection regulations. Study data will be collected and pseudonymized according to applicable ethical and regulatory requirements and institutional data-sharing agreements.

Publications

  • Andreoli F, Mattiussi F, Wasseh E, et al. NornirNet: a deep learning framework to distinguish benign from malignant type II endoleaks after endovascular aortic aneurysm repair using preoperative imaging. AI. 2026;7(2):57. doi:10.3390/ai7020057

  • Powell JT, Sweeting MJ, Ulug P, Blankensteijn JD, Lederle FA, Becquemin JP, Greenhalgh RM; EVAR-1, DREAM, OVER and ACE Trialists. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years. Br J Surg. 2017 Feb;104(3):166-178. doi: 10.1002/bjs.10430.

    PubMed 28160528

  • Collins GS, Moons KGM, Dhiman P, Riley RD, Beam AL, Van Calster B, Ghassemi M, Liu X, Reitsma JB, van Smeden M, Boulesteix AL, Camaradou JC, Celi LA, Denaxas S, Denniston AK, Glocker B, Golub RM, Harvey H, Heinze G, Hoffman MM, Kengne AP, Lam E, Lee N, Loder EW, Maier-Hein L, Mateen BA, McCradden MD, Oakden-Rayner L, Ordish J, Parnell R, Rose S, Singh K, Wynants L, Logullo P. TRIPOD+AI statement: updated guidance for reporting clinical prediction models that use regression or machine learning methods. BMJ. 2024 Apr 16;385:e078378. doi: 10.1136/bmj-2023-078378.

    PubMed 38626948

  • Riley RD, Debray TPA, Collins GS, Archer L, Ensor J, van Smeden M, Snell KIE. Minimum sample size for external validation of a clinical prediction model with a binary outcome. Stat Med. 2021 Aug 30;40(19):4230-4251. doi: 10.1002/sim.9025. Epub 2021 May 24.

    PubMed 34031906

  • Charalambous S, Klontzas ME, Kontopodis N, Ioannou CV, Perisinakis K, Maris TG, Damilakis J, Karantanas A, Tsetis D. Radiomics and machine learning to predict aggressive type 2 endoleaks after endovascular aneurysm repair: a proof of concept. Acta Radiol. 2022 Sep;63(9):1293-1299. doi: 10.1177/02841851211032443. Epub 2021 Jul 27.

    PubMed 34313492

  • Fedorov A, Beichel R, Kalpathy-Cramer J, Finet J, Fillion-Robin JC, Pujol S, Bauer C, Jennings D, Fennessy F, Sonka M, Buatti J, Aylward S, Miller JV, Pieper S, Kikinis R. 3D Slicer as an image computing platform for the Quantitative Imaging Network. Magn Reson Imaging. 2012 Nov;30(9):1323-41. doi: 10.1016/j.mri.2012.05.001. Epub 2012 Jul 6.

    PubMed 22770690

  • van Timmeren JE, Cester D, Tanadini-Lang S, Alkadhi H, Baessler B. Radiomics in medical imaging-"how-to" guide and critical reflection. Insights Imaging. 2020 Aug 12;11(1):91. doi: 10.1186/s13244-020-00887-2.

    PubMed 32785796

  • van Griethuysen JJM, Fedorov A, Parmar C, Hosny A, Aucoin N, Narayan V, Beets-Tan RGH, Fillion-Robin JC, Pieper S, Aerts HJWL. Computational Radiomics System to Decode the Radiographic Phenotype. Cancer Res. 2017 Nov 1;77(21):e104-e107. doi: 10.1158/0008-5472.CAN-17-0339.

    PubMed 29092951

  • Otsu M, Ishizaka T, Watanabe M, Hori T, Kohno H, Ishida K, Nakaya M, Matsumiya G. Analysis of anatomical risk factors for persistent type II endoleaks following endovascular abdominal aortic aneurysm repair using CT angiography. Surg Today. 2016 Jan;46(1):48-55. doi: 10.1007/s00595-015-1115-5. Epub 2015 Jan 13.

    PubMed 25578204

  • Couchet G, Pereira B, Carrieres C, Maumias T, Ribal JP, Ben Ahmed S, Rosset E. Predictive Factors for Type II Endoleaks after Treatment of Abdominal Aortic Aneurysm by Conventional Endovascular Aneurysm Repair. Ann Vasc Surg. 2015 Nov;29(8):1673-9. doi: 10.1016/j.avsg.2015.07.007. Epub 2015 Aug 22.

    PubMed 26303269

  • Marchiori A, von Ristow A, Guimaraes M, Schonholz C, Uflacker R. Predictive factors for the development of type II endoleaks. J Endovasc Ther. 2011 Jun;18(3):299-305. doi: 10.1583/10-3116.1.

    PubMed 21679064

  • Lo RC, Buck DB, Herrmann J, Hamdan AD, Wyers M, Patel VI, Fillinger M, Schermerhorn ML; Vascular Study Group of New England. Risk factors and consequences of persistent type II endoleaks. J Vasc Surg. 2016 Apr;63(4):895-901. doi: 10.1016/j.jvs.2015.10.088. Epub 2016 Jan 12.

    PubMed 26796291

  • Yu HYH, Lindstrom D, Wanhainen A, Tegler G, Hassan B, Mani K. Systematic review and meta-analysis of prophylactic aortic side branch embolization to prevent type II endoleaks. J Vasc Surg. 2020 Nov;72(5):1783-1792.e1. doi: 10.1016/j.jvs.2020.05.020. Epub 2020 May 19.

    PubMed 32442608

  • Yu HYH, Lindstrom D, Wanhainen A, Tegler G, Asciutto G, Mani K. An updated systematic review and meta-analysis of pre-emptive aortic side branch embolization to prevent type II endoleaks after endovascular aneurysm repair. J Vasc Surg. 2023 Jun;77(6):1815-1821. doi: 10.1016/j.jvs.2022.11.042. Epub 2022 Nov 15.

    PubMed 36400361

  • Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.

    PubMed 29268916

Questions about this trial

What is this clinical trial studying?

An observational study of Type II Endoleak and Abdominal Aortic Aneurysm Enlargement, run by Ente Ospedaliero Cantonale, Bellinzona.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giorgio Prouse, MD (+41 91 811 6328, giorgio.prouse@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of the deep-learning model in held-out test centers (time frame: From the baseline postoperative CTA (1-3 months after EVAR) through the last available follow-up, T2EL-related reintervention, censoring event, death, or administrative censoring on 31 December 2026.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07783126, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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