- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07640828
Digital Twin and Ml-basEd MOdel of TEVAR Interventions (MEMO)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: SANTI TRIMARCHI, MD, PHD
- Número de teléfono: +390255032438
- Correo electrónico: santi.trimarchi@policlinico.mi.it
Ubicaciones de estudio
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Milan, Italia
- Reclutamiento
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
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Contacto:
- SANTI TRIMARCHI, MD, PHD
- Número de teléfono: +390255032438
- Correo electrónico: santi.trimarchi@policlinico.mi.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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:
- 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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Determine the accuracy of patient-specific numerical simulations in replicating TEVAR deployment outcomes
Periodo de tiempo: up to 1 year
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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
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up to 1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Assess the predictive performance of the ML model in forecasting clinical complications
Periodo de tiempo: up to 1 year
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Sensitivity, specificity, and AUC of the model in predicting complications using retrospective clinical follow-up data
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up to 1 year
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 6492
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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