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RecruitingNCT07640828MEMOUpdated Nov 4, 2026

Digital Twin and Ml-basEd MOdel of TEVAR Interventions

An observational study in Aorta Disease and Aorta, Thoracic Pathologies, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Updated Nov 4, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study summary

The study aims to collect clinical data and pseudonymized CT images of patients undergoing TEVAR in order to create an anatomical digital twin capable of simulating procedural outcomes and training machine learning (ML) algorithms. This approach will support predictive models that may assist physicians in selecting the optimal medical device, improving pre-TEVAR planning, and predicting post-TEVAR complications.

Read the detailed description

In recent years, Thoracic Endovascular Aortic Repair (TEVAR) has become increasingly utilized for the treatment of thoracic aortic pathologies. Over the past two decades, the adoption of TEVAR has grown significantly, progressively replacing open surgery as the preferred treatment approach in many cases. Initially designed for interventions involving the descending thoracic aorta, TEVAR is now being extended to more complex anatomies, including the aortic arch and even regions closer to the aortic root.

Successful TEVAR procedures rely on accurate preoperative planning and detailed clinical assessment to optimize patient outcomes. Although TEVAR offers several advantages over open surgery, including reduced procedural risk, shorter recovery time, and lower morbidity, it is not without limitations. Major complications include endoleaks, stent-induced new entry tears, vessel obstruction, and stent migration, all of which may significantly affect patient prognosis. Despite existing manufacturer guidelines and deployment strategies, these complications remain difficult to predict.

Previous studies have reported endoleak rates ranging from 4% to 15%, stent migration rates between 1.0% and 2.8%, and device-related complications occurring in up to 38% of cases. Recent advances in computational modeling have demonstrated considerable potential for improving TEVAR planning and risk prediction. Finite element analysis (FEA) and fluid-structure interaction (FSI) simulations have proven valuable for assessing stent behavior within patient-specific anatomies. Through in silico simulations, different stent types and diameter configurations can be virtually tested, providing surgeons with critical insights for clinical decision-making.

However, despite their high accuracy, these techniques are computationally intensive and require large datasets as well as specialized expertise, limiting their accessibility for routine clinical practice. To address these challenges, numerical models (e.g., finite element simulations) and machine learning (ML) approaches represent promising alternatives for real-time, data-driven perioperative decision support. By integrating finite element simulations with clinical imaging data, ML algorithms can be trained to predict procedural outcomes, optimize prosthesis selection, and estimate post-interventional risks. This approach not only enhances pre-procedural planning but also facilitates postoperative risk assessment, ultimately contributing to improved patient management.

A critical challenge in developing robust ML models for TEVAR planning is the limited accessibility of high-quality annotated datasets and their integration into clinical workflows. To overcome this limitation, the study proposes a comprehensive methodology aimed at:

I) collecting clinical and imaging data relevant to TEVAR procedures; II) augmenting patient-specific anatomical data using statistical shape modeling (SSM) to generate a diverse training dataset; III) developing high-fidelity digital twins that provide personalized virtual replicas of individual TEVAR cases; and IV) training ML models on these augmented datasets to predict procedural outcomes based on patient-specific characteristics.

Using these techniques, the study aims to develop a clinically viable framework capable of predicting surgical outcomes and increasing the information available for surgeons during preoperative decision-making, thereby improving patient outcomes in TEVAR interventions.

02

Conditions studied

  • Aorta Disease
  • Aorta, Thoracic Pathologies

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Keywords

  • machine learning
  • thoracic aorta
  • Finite Element Analysis
03

In context

Aortic Diseases

108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 186 across 62 observational studies indexed under Aortic Diseases.

Browse Aortic Diseases studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 233 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients undergoing TEVAR

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥18 Years and older (Adult, Older Adult)
  • Female and male
  • Received TEVAR for: Chronic or acute dissection, Aneurysm, Penetrating aortic ulcer, aortic thrombus, intramural hematoma or traumatic injury

Exclusion criteria

Exclusion Criteria:

  • Younger than 18 years old
  • Received TEVAR in surgical graft that replaced native aorta
  • Poor CT image quality that leads to failure in generating a high-fidelity 3D FE model of patient anatomy (no preoperative multidetector contrast-enhanced CT-scan available, preoperative CTscan slice thickness greater than 1mm, preoperative CT-scan with artifacts, motion artifacts due to the presence of other implanted devices affecting the region of interest)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Determine the accuracy of patient-specific numerical simulations in replicating TEVAR deployment outcomes

    Accuracy of the simulations, expressed in terms of the match between simulated and post-operative device-vessel interaction (e.g., configuration, sealing quality, apposition), as assessed via comparison of post-operative CT image with the simulation results

    Time frame: up to 1 year

Secondary outcomes

  1. Assess the predictive performance of the ML model in forecasting clinical complications

    Sensitivity, specificity, and AUC of the model in predicting complications using retrospective clinical follow-up data

    Time frame: up to 1 year

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Primary completion
Sep 30, 2026→Mar 31, 2027
Nov 4, 2026
Study completion
Sep 30, 2026→Mar 31, 2027
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Primary completion Sep 30, 2026→Mar 31, 2027
    Study completion Sep 30, 2026→Mar 31, 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07640828
Responsible party
Sponsor
First posted
Jun 11, 2026
Start date
Feb 11, 2026
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

SANTI TRIMARCHI, MD, PHD
Contact
santi.trimarchi@policlinico.mi.it
+390255032438

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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