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Aorta DiseaseMEMONCT07640828

Digital Twin and Ml-basEd MOdel of TEVAR Interventions

An observational study of Aorta Disease and Aorta, Thoracic Pathologies, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aorta Disease, Aorta, Thoracic Pathologies
How many people
5,000 participants
Where
1 siteItaly
Study dates
11 Feb 2026to 30 Sep 2026
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: patients undergoing TEVAR

Who may be able to join

  • ≥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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

SANTI TRIMARCHI, MD, PHD contact

+390255032438

santi.trimarchi@policlinico.mi.it

Italy1 site, 1 recruiting
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

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

    Recruiting

Other trials in Italy

About this study

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:

  1. 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.

Keywords
machine learning, thoracic aorta, Finite Element Analysis
Medical subject headings
Aortic Diseases

What is being measured

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

  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

    Measured: up to 1 year

Secondary outcomes (1)
  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

    Measured: up to 1 year

Timeline

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

  1. First posted11 Jun 2026
  2. Study start11 Feb 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (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
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07640828
Sponsor's protocol ID
6492
Acronym
MEMO
Status last verified
Apr 2026
First submitted
4 May 2026
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aorta Disease and Aorta, Thoracic Pathologies, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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 SANTI TRIMARCHI, MD, PHD (+390255032438, santi.trimarchi@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the accuracy of patient-specific numerical simulations in replicating TEVAR deployment outcomes (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Jun 2026.

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