Thoracic Aortic AneurysmMALANNCT03824626
Biomechanical Reappraisal of Planning for Thoracic Endovascular Aortic Repair
An observational study of Thoracic Aortic Aneurysm and Aortic Dissection, run by Ospedale San Donato at 1 site in Italy.
Trial summary
Thoracic endovascular aortic repair (TEVAR) for disease involving the aortic arch remains complex and challenging due the angulation and tortuosity of the arch and its peculiar biomechanical environment. Currently, TEVAR planning is based on the analysis of anatomical features by means of static imaging protocols. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysm, Aortic Dissection, Aortic Diseases
- What is being tested?
- TEVAR patients
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2019to 30 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 with chronic thoracic aortic pathologies, including atherosclerotic and post-dissection aneurysms, and penetrating ulcer/intramural hematoma, scheduled for elective TEVAR with surgical supra-aortic vessel (SAV) debranching. Indication to treatment, endovascular procedure, and follow-up will be established and performed according to Guidelines
Who may be able to join
- Age over 18 years old
- Must be able to give Informed Consent
- Must to be enrolled at the Surgery Unit of one of the recruitment centres with chronic thoracic aortic pathologies (including atherosclerotic and post-dissection aneurysms, and penetrating ulcer/intramural hematoma)
- Must to be scheduled for elective TEVAR with surgical supra-aortic vessel (SAV) debranching (established and performed according to Guidelines)
Who cannot join
- Patients with previous aortic surgical or endovascular procedures
- General contraindications to MRI or CT studies
- Suspected or manifested pregnancy
- Systemic diseases judged non-compatible with the procedures
- Any incapability to give informed consent
Trial locations and contacts
1 site in 1 country.
Massimiliano M Marrocco-Trischitta, MD,PhD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097
Massimiliano M Marrocco Trischitta, MD, (+39) 025277 ext. 4344, Massimiliano.MarroccoTrischitta@grupposandonato.it
About this study
Official title: Mapping of Aortic Arch Hemodynamics by Biomechanical Analysis and Modeling for Planning Thoracic Endovascular Aortic Repair
Thoracic endovascular aortic repair (TEVAR) for disease involving the aortic arch remains complex and challenging due the angulation and tortuosity of the arch and its peculiar biomechanical environment. Currently, TEVAR planning is based on the analysis of anatomical features by means of static imaging protocols. Such an approach, however, disregards the impact of pulsatile forces that are transmitted as migration forces on the terminal fixation sites of the endograft, and may jeopardize the long-term clinical success of the procedure. Hence,the investigators aim to assess the migration forces acting on different proximal landing zones of the aortic arch by computational modeling, and develop in silico patient-specific simulations that can provide a quantitative evaluation of the stent-graft performance. Study's results are expected to provide valuable insights for proper proximal landing zone and stent-graft selection during TEVAR planning, and ultimately improve postoperative outcome.
Read the detailed description
Hypothesis and Significance: Specific and consistent fluid dynamic patterns and drag forces magnitude and distribution can be identified in the PLZs of the aortic arch providing valuable insights for proper PLZ and stent-graft selection during TEVAR planning.
Specific Aim: 1) To assess the drag forces acting on different PLZs of the aortic arch by means of Computed Fluid Dynamic (CFD) analysis of preoperative phase contrast-Magnetic Resonance (pc-MRI) and Computed Tomography Angiography (CTA) images. The specific goal is to identify the correlation between different magnitude and direction of migration forces and geometrical patterns of the arch to identify suboptimal landing zones for stent-graft deployment. 2) To develop and perform in-silico simulations of the deployment of different commercially available endografts with patient specific boundary conditions. The exact goal is to assess the impact of the mechanical characteristics of a specific device on the vessel wall by structural finite element analysis (FEA), and on the drag forces in different landing zones by CFD, to identify the more suitable endograft. 3) To assess the drag forces exerted postoperatively on the endograft by means of CFD analysis based on follow-up images (i.e., pc-MRI and CTA). The specific goal is to evaluate the predictive value of the drag forces measured preoperatively in the PLZs, and validate the results from in-silico simulations.
Experimental Design Aim 1: Preoperative medical images acquisition: CTA will be performed using a 16-slice unit (150 mAs, 110 kVp; acquisition thickness 5 mm, pitch 1.5; reconstruction thickness 1.2 mm), before and after intravenous administration of 100 mL of iodinated contrast material. MRI will be performed using a 1.5-T unit with 40-mT/m gradient power (Magneton Sonata Maestro Class, Siemens, Erlangen, Germany) and a four-channel cardio-thoracic coil. ECG-triggered, free-breathing through plane, and in-plane pc-MRI sequences will be performed for phase-velocity mapping of aortic and branches flow with the following technical parameters: TR/TE = 4/3.2 ms, thickness 5 mm, velocity encoding from 150 to 350 ms, and temporal resolution 41 ms.
Medical images processing: Ad hoc processing of preoperative CTAs, based on 3D multiplanar reconstruction, will be performed with 3Mensio Vascular software 8.0® (3Mensio Medical Imaging B.V.), which provides specific functions for automatic measurements. Patients will be stratified according to Aortic Arches Classification (AAC). Radius of curvature, PLZs angulation (tangent angle function) and tortuosity (tortuosity angle function) will be calculated. 3D segmentation of CTA, aimed for in-silico simulation purposes, will be performed by the software Mimics v18.0 (Materialise, Belgium). The 3D model of the aortic lumen in stl format will be used to create CFD suitable computational domain, called mesh by vmtk toolkit (www.vmtk.org). In-silico simulations: State-of-the-art CFD simulations for aortic hemodynamics will be performed by the CFD solver developed by the project EmPaTHIC (Emory Pavia Testing Hemodynamics) that updates LifeV Application Blood Flow through the collaboration among Emory University, Atlanta,Georgia,USA (Prof. A. Veneziani) and University of Pavia (UniPV) (Prof. F. Auricchio). The analysis will run on the cluster available at UniPV Nume-Lab. The project foresees to increase the computational power by adding another node to the available UniPV cluster and also the set-up of a server at Policlinico San Donato (PSD) dedicated to data storage and visualization of the results. Computation of drag forces: The post-processing of the simulations will be performed by python-scripts based on Visualization Toolkit (VTK) libraries and ParaView software (Kitware® Inc., France). Such an analysis aims at computing semi-automatically the aortic centerline, splitting the aortic arch in four regions (i.e., landing zones), and calculating the magnitude and direction of the drag forces in each zone, through the whole cardiac cycle. Preliminary analysis will be performed to assess if the systolic peak is the most relevant time instant for our purposes, in order to possibly reduce the post-processing efforts.
Experimental Design Aim 2: Medical images acquisition: The pre-operative images acquired for Aim 1 will be used. Medical images processing: The 3D models of the aortic lumen derived from the processing performed for Aim 1 will be used. In-silico simulations, Two types of analysis will be performed: 1) Simulation of TEVAR by FEA to predict endograft apposition; 2) CFD analysis to compute post-TEVAR hemodynamics. These simulations will be performed in a serial manner defining a computational framework, which is already developed and tested. FEA of TEVAR: As previously reported by our Group, the geometrical models of the implanted endografts resemble the main features of real endografts samples; mechanical properties are derived from available literature. ABAQUSv16 (Simulia, Dassault Systèmes®, FR) is used as FEA solver. CFD for post- TEVAR hemodynamics: Starting from the configuration of the endograft predicted by the FEA, the computational domain, resembling the aorta with the endovascular implant, is build using image-distance technique. The analysis is then run as described in Aim 1. Computation of drag forces: As described in Aim 1, the developed post-processing tool will be used to compute the magnitude and direction of the drag forces along the arch, and also on the inner surface of the deployed endograft.
Experimental Design Aim 3: Postoperative medical images acquisition: CTA and MRI studies and ad-hoc analysis of the images will be performed at 6-month follow-up in recruited patients as described in Aim 1. In-silico simulations: CFD analyses will be performed as described in Aim 1. Medical images processing: The same approach and the same tools proposed in Aim 1 will be used. Segmentation of post-operative CTA will be performed to reconstruct a 3D model of the aortic lumen and of the struts of the deployed endografts. Computation of drag forces and validation: As in Aim 1, 3D segmentation of post-operative CTA combined with flow data from pc-MRI will be used to run CFD analysis in order to: 1) Assess the predictive value of the drag forces measured preoperatively (Aim 1); 2) Validate the results from in-silico simulations (Aim 2).
- Conditions
- Thoracic Aortic Aneurysm, Aortic Dissection, Aortic Diseases
- Being tested
- TEVAR patients
- Keywords
- thoracic endovascular aortic repair, computational fluid dynamics, preoperative planning
- Medical subject headings
- Aortic Aneurysm, Thoracic, Aortic Dissection, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEVAR patientsDiagnostic test
Also called CTA and pc-MRI
Computed Tomography Angiography (CTA) will be performed using a 16-slice unit before and after intravenous administration of 100 mL of iodinated contrast material. Phase contrast-Magnetic Resonance (pc-MRI) will be performed using a 1.5-T unit with 40-mT/m gradient power and a four-channel cardio-thoracic coil. ECG-triggered, free-breathing through plane, and in-plane pc-MRI sequences will be performed for phase-velocity mapping of aortic and branches flow. Ad hoc processing of preoperative CTAs, based on 3D multiplanar reconstruction, will be performed with 3Mensio Vascular software 8.0® (3Mensio Medical Imaging B.V.), which provides specific functions for automatic measurements.
| Study group | Role | What they receive |
|---|---|---|
| TEVAR patients | patients scheduled for thoracic endovascular aortic repair Receives: Diagnostic Test: TEVAR patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement Force [magnitude (N)]
Comparison among the Type of Arch (TOA); Comparison among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR)
Measured: 18 months
Displacement Force [Vector (-)]
Comparison among the Type of Arch (TOA); Comparison among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR)
Measured: 18 months
Secondary outcomes (14)
Area of proximal landing zones (PLZs) (mm2)
Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR
Measured: 18 months
Equivalent Surface Traction (EST) (N/ mm2)
Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR
Measured: 18 months
Radius of curvature (1/mm)
Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR
Measured: 18 months
Angulation (tangent angle function)
Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR
Measured: 18 months
Tortuosity (tortuosity angle function)
Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR
Measured: 18 months
Mean and maximum flow velocity magnitude (cm/sec) in aortic along the cardiac cycle
Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR
Measured: 18 months
Systolic wall shear stress (dyn/cm2)
Comparison among the TOA and PLZs
Measured: 18 months
Time-averaged wall shear stress (TAWSS) (dyn/cm2)
Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR
Measured: 18 months
Oscillatory index (OSI) (%)
Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR
Measured: 18 months
Flow helicity
Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR
Measured: 18 months
Aortic inflow (L/min)
Comparison among the TOA; Comparison among pre- and post-TEVAR
Measured: 18 months
Aortic flow split (%)
Comparison among the TOA; Comparison among pre- and post-TEVAR
Measured: 18 months
Brachial arterial pressure (mmHg)
Comparison among the TOA; Comparison among pre- and post-TEVAR
Measured: 18 months
Mean and maximum arterial pressure (mmHg)
Comparison among the TOA; Comparison among pre- and post-TEVAR
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start23 May 2019
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Principal investigator, Massimiliano M. Marrocco-Trischitta, Ospedale San Donato
- Investigators
- Massimiliano M Marrocco-Trischitta, MD,PhD, Principal investigator, Ospedale San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824626
- Sponsor's protocol ID
- 160/int/2017
- Acronym
- MALAN
- Status last verified
- Oct 2020
- First submitted
- 25 Jan 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marrocco-Trischitta MM, Melissano G, Kahlberg A, Calori G, Setacci F, Chiesa R. Chronic kidney disease classification stratifies mortality risk after elective stent graft repair of the thoracic aorta. J Vasc Surg. 2009 Feb;49(2):296-301. doi: 10.1016/j.jvs.2008.09.041. Epub 2008 Nov 22.
PubMed 19028056Bockler D, Brunkwall J, Taylor PR, Mangialardi N, Husing J, Larzon T; CTAG registry investigators. Thoracic Endovascular Aortic Repair of Aortic Arch Pathologies with the Conformable Thoracic Aortic Graft: Early and 2 year Results from a European Multicentre Registry. Eur J Vasc Endovasc Surg. 2016 Jun;51(6):791-800. doi: 10.1016/j.ejvs.2016.02.006. Epub 2016 Apr 20.
PubMed 27107487Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014 Nov 1;35(41):2873-926. doi: 10.1093/eurheartj/ehu281. Epub 2014 Aug 29. No abstract available.
PubMed 25173340van Bogerijen GH, Tolenaar JL, Conti M, Auricchio F, Secchi F, Sardanelli F, Moll FL, van Herwaarden JA, Rampoldi V, Trimarchi S. Contemporary Role of Computational Analysis in Endovascular Treatment for Thoracic Aortic Disease. Aorta (Stamford). 2013 Aug 1;1(3):171-81. doi: 10.12945/j.aorta.2013.13-003. eCollection 2013 Aug.
PubMed 26798690Ishimaru S. Endografting of the aortic arch. J Endovasc Ther. 2004 Dec;11 Suppl 2:II62-71. doi: 10.1177/15266028040110S614.
PubMed 15760265Marrocco-Trischitta MM, de Beaufort HW, Secchi F, van Bakel TM, Ranucci M, van Herwaarden JA, Moll FL, Trimarchi S. A geometric reappraisal of proximal landing zones for thoracic endovascular aortic repair according to aortic arch types. J Vasc Surg. 2017 Jun;65(6):1584-1590. doi: 10.1016/j.jvs.2016.10.113. Epub 2017 Feb 20.
PubMed 28222992Madhwal S, Rajagopal V, Bhatt DL, Bajzer CT, Whitlow P, Kapadia SR. Predictors of difficult carotid stenting as determined by aortic arch angiography. J Invasive Cardiol. 2008 May;20(5):200-4.
PubMed 18460700Molony DS, Kavanagh EG, Madhavan P, Walsh MT, McGloughlin TM. A computational study of the magnitude and direction of migration forces in patient-specific abdominal aortic aneurysm stent-grafts. Eur J Vasc Endovasc Surg. 2010 Sep;40(3):332-9. doi: 10.1016/j.ejvs.2010.06.001. Epub 2010 Jun 22.
PubMed 20573524Auricchio F, Conti M, Marconi S, Reali A, Tolenaar JL, Trimarchi S. Patient-specific aortic endografting simulation: from diagnosis to prediction. Comput Biol Med. 2013 May;43(4):386-94. doi: 10.1016/j.compbiomed.2013.01.006. Epub 2013 Feb 8.
PubMed 23395199Auricchio, F., Conti, M., Lefieux, A. et al. Comput Mech (2014) 54: 943. https://doi.org/10.1007/s00466-014-0976-6
Grabenwoger M, Alfonso F, Bachet J, Bonser R, Czerny M, Eggebrecht H, Evangelista A, Fattori R, Jakob H, Lonn L, Nienaber CA, Rocchi G, Rousseau H, Thompson M, Weigang E, Erbel R. Thoracic Endovascular Aortic Repair (TEVAR) for the treatment of aortic diseases: a position statement from the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2012 Jul;33(13):1558-63. doi: 10.1093/eurheartj/ehs074. Epub 2012 May 4. No abstract available.
PubMed 22561257Corbett TJ, Callanan A, O'Donnell MR, McGloughlin TM. An improved methodology for investigating the parameters influencing migration resistance of abdominal aortic stent-grafts. J Endovasc Ther. 2010 Feb;17(1):95-107. doi: 10.1583/09-2920.1.
PubMed 20199275Elena Faggiano, Tommaso Lorenzi & Alfio Quarteroni (2016) Metal artefact reduction in computed tomography images by a fourth-order total variation flow, Computer Methods in Biomechanics and Biomedical Engineering: Imaging & Visualization, 4:3-4, 202-213, DOI: 10.1080/21681163.2014.940629
Migliavacca F, Balossino R, Pennati G, Dubini G, Hsia TY, de Leval MR, Bove EL. Multiscale modelling in biofluidynamics: application to reconstructive paediatric cardiac surgery. J Biomech. 2006;39(6):1010-20. doi: 10.1016/j.jbiomech.2005.02.021. Epub 2005 Apr 25.
PubMed 16549092Gillen JR, Schaheen BW, Yount KW, Cherry KJ, Kern JA, Kron IL, Upchurch GR Jr, Lau CL. Cost analysis of endovascular versus open repair in the treatment of thoracic aortic aneurysms. J Vasc Surg. 2015 Mar;61(3):596-603. doi: 10.1016/j.jvs.2014.09.009. Epub 2014 Oct 27.
PubMed 25449008
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping of Aortic Arch Hemodynamics by Biomechanical Analysis and Modeling for Planning Thoracic Endovascular Aortic Repair
- ClinicalTrials.gov ID
- NCT03824626
- Acronym / sponsor ID
- MALAN / 160/int/2017
- Conditions
- Thoracic Aortic Aneurysm, Aortic Dissection, Aortic Diseases
- Keywords
- thoracic endovascular aortic repair, computational fluid dynamics, preoperative planning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- 23 May 2019 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thoracic endovascular aortic repair (TEVAR) for disease involving the aortic arch remains complex and challenging due the angulation and tortuosity of the arch and its peculiar biomechanical environment. Currently, TEVAR planning is based on the analysis of anatomical features by means of static imaging protocols. Such an approach, however, disregards the impact of pulsatile forces that are transmitted as migration forces on the terminal fixation sites of the endograft, and may jeopardize the long-term clinical success of the procedure. Hence,the investigators aim to assess the migration forces acting on different proximal landing zones of the aortic arch by computational modeling, and develop in silico patient-specific simulations that can provide a quantitative evaluation of the stent-graft performance. Study's results are expected to provide valuable insights for proper proximal landing zone and stent-graft selection during TEVAR planning, and ultimately improve postoperative outcome.
Detailed description
Hypothesis and Significance: Specific and consistent fluid dynamic patterns and drag forces magnitude and distribution can be identified in the PLZs of the aortic arch providing valuable insights for proper PLZ and stent-graft selection during TEVAR planning.
Specific Aim: 1) To assess the drag forces acting on different PLZs of the aortic arch by means of Computed Fluid Dynamic (CFD) analysis of preoperative phase contrast-Magnetic Resonance (pc-MRI) and Computed Tomography Angiography (CTA) images. The specific goal is to identify the correlation between different magnitude and direction of migration forces and geometrical patterns of the arch to identify suboptimal landing zones for stent-graft deployment. 2) To develop and perform in-silico simulations of the deployment of different commercially available endografts with patient specific boundary conditions. The exact goal is to assess the impact of the mechanical characteristics of a specific device on the vessel wall by structural finite element analysis (FEA), and on the drag forces in different landing zones by CFD, to identify the more suitable endograft. 3) To assess the drag forces exerted postoperatively on the endograft by means of CFD analysis based on follow-up images (i.e., pc-MRI and CTA). The specific goal is to evaluate the predictive value of the drag forces measured preoperatively in the PLZs, and validate the results from in-silico simulations.
Experimental Design Aim 1: Preoperative medical images acquisition: CTA will be performed using a 16-slice unit (150 mAs, 110 kVp; acquisition thickness 5 mm, pitch 1.5; reconstruction thickness 1.2 mm), before and after intravenous administration of 100 mL of iodinated contrast material. MRI will be performed using a 1.5-T unit with 40-mT/m gradient power (Magneton Sonata Maestro Class, Siemens, Erlangen, Germany) and a four-channel cardio-thoracic coil. ECG-triggered, free-breathing through plane, and in-plane pc-MRI sequences will be performed for phase-velocity mapping of aortic and branches flow with the following technical parameters: TR/TE = 4/3.2 ms, thickness 5 mm, velocity encoding from 150 to 350 ms, and temporal resolution 41 ms.
Medical images processing: Ad hoc processing of preoperative CTAs, based on 3D multiplanar reconstruction, will be performed with 3Mensio Vascular software 8.0® (3Mensio Medical Imaging B.V.), which provides specific functions for automatic measurements. Patients will be stratified according to Aortic Arches Classification (AAC). Radius of curvature, PLZs angulation (tangent angle function) and tortuosity (tortuosity angle function) will be calculated. 3D segmentation of CTA, aimed for in-silico simulation purposes, will be performed by the software Mimics v18.0 (Materialise, Belgium). The 3D model of the aortic lumen in stl format will be used to create CFD suitable computational domain, called mesh by vmtk toolkit (www.vmtk.org). In-silico simulations: State-of-the-art CFD simulations for aortic hemodynamics will be performed by the CFD solver developed by the project EmPaTHIC (Emory Pavia Testing Hemodynamics) that updates LifeV Application Blood Flow through the collaboration among Emory University, Atlanta,Georgia,USA (Prof. A. Veneziani) and University of Pavia (UniPV) (Prof. F. Auricchio). The analysis will run on the cluster available at UniPV Nume-Lab. The project foresees to increase the computational power by adding another node to the available UniPV cluster and also the set-up of a server at Policlinico San Donato (PSD) dedicated to data storage and visualization of the results. Computation of drag forces: The post-processing of the simulations will be performed by python-scripts based on Visualization Toolkit (VTK) libraries and ParaView software (Kitware® Inc., France). Such an analysis aims at computing semi-automatically the aortic centerline, splitting the aortic arch in four regions (i.e., landing zones), and calculating the magnitude and direction of the drag forces in each zone, through the whole cardiac cycle. Preliminary analysis will be performed to assess if the systolic peak is the most relevant time instant for our purposes, in order to possibly reduce the post-processing efforts.
Experimental Design Aim 2: Medical images acquisition: The pre-operative images acquired for Aim 1 will be used. Medical images processing: The 3D models of the aortic lumen derived from the processing performed for Aim 1 will be used. In-silico simulations, Two types of analysis will be performed: 1) Simulation of TEVAR by FEA to predict endograft apposition; 2) CFD analysis to compute post-TEVAR hemodynamics. These simulations will be performed in a serial manner defining a computational framework, which is already developed and tested. FEA of TEVAR: As previously reported by our Group, the geometrical models of the implanted endografts resemble the main features of real endografts samples; mechanical properties are derived from available literature. ABAQUSv16 (Simulia, Dassault Systèmes®, FR) is used as FEA solver. CFD for post- TEVAR hemodynamics: Starting from the configuration of the endograft predicted by the FEA, the computational domain, resembling the aorta with the endovascular implant, is build using image-distance technique. The analysis is then run as described in Aim 1. Computation of drag forces: As described in Aim 1, the developed post-processing tool will be used to compute the magnitude and direction of the drag forces along the arch, and also on the inner surface of the deployed endograft.
Experimental Design Aim 3: Postoperative medical images acquisition: CTA and MRI studies and ad-hoc analysis of the images will be performed at 6-month follow-up in recruited patients as described in Aim 1. In-silico simulations: CFD analyses will be performed as described in Aim 1. Medical images processing: The same approach and the same tools proposed in Aim 1 will be used. Segmentation of post-operative CTA will be performed to reconstruct a 3D model of the aortic lumen and of the struts of the deployed endografts. Computation of drag forces and validation: As in Aim 1, 3D segmentation of post-operative CTA combined with flow data from pc-MRI will be used to run CFD analysis in order to: 1) Assess the predictive value of the drag forces measured preoperatively (Aim 1); 2) Validate the results from in-silico simulations (Aim 2).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEVAR patients | – | Diagnostic Test: TEVAR patientspatients scheduled for thoracic endovascular aortic repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic thoracic aortic pathologies, including atherosclerotic and post-dissection aneurysms, and penetrating ulcer/intramural hematoma, scheduled for elective TEVAR with surgical supra-aortic vessel (SAV) debranching. Indication to treatment, endovascular procedure, and follow-up will be established and performed according to Guidelines
Key inclusion criteria (4 listed)
- Age over 18 years old
- Must be able to give Informed Consent
- Must to be enrolled at the Surgery Unit of one of the recruitment centres with chronic thoracic aortic pathologies (including atherosclerotic and post-dissection aneurysms, and penetrating ulcer/intramural hematoma)
- Must to be scheduled for elective TEVAR with surgical supra-aortic vessel (SAV) debranching (established and performed according to Guidelines)
Key exclusion criteria (5 listed)
- Patients with previous aortic surgical or endovascular procedures
- General contraindications to MRI or CT studies
- Suspected or manifested pregnancy
- Systemic diseases judged non-compatible with the procedures
- Any incapability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEVAR patientsAlso: CTA and pc-MRIComputed Tomography Angiography (CTA) will be performed using a 16-slice unit before and after intravenous administration of 100 mL of iodinated contrast material. Phase contrast-Magnetic Resonance (pc-MRI) will be performed using a 1.5-T unit with 40-mT/m gradient power and a four-channel cardio-thoracic coil. ECG-triggered, free-breathing through plane, and in-plane pc-MRI sequences will be performed for phase-velocity mapping of aortic and branches flow. Ad hoc processing of preoperative CTAs, based on 3D multiplanar reconstruction, will be performed with 3Mensio Vascular software 8.0® (3Mensio Medical Imaging B.V.), which provides specific functions for automatic measurements. | Diagnostic test | TEVAR patients |
Primary outcome
Displacement Force [magnitude (N)]
Time frame: 18 months
Comparison among the Type of Arch (TOA); Comparison among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR)
Displacement Force [Vector (-)]
Time frame: 18 months
Comparison among the Type of Arch (TOA); Comparison among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR)
14 secondary outcomes
Area of proximal landing zones (PLZs) (mm2)
Time frame: 18 months
Equivalent Surface Traction (EST) (N/ mm2)
Time frame: 18 months
Radius of curvature (1/mm)
Time frame: 18 months
Angulation (tangent angle function)
Time frame: 18 months
Tortuosity (tortuosity angle function)
Time frame: 18 months
Mean and maximum flow velocity magnitude (cm/sec) in aortic along the cardiac cycle
Time frame: 18 months
Systolic wall shear stress (dyn/cm2)
Time frame: 18 months
Time-averaged wall shear stress (TAWSS) (dyn/cm2)
Time frame: 18 months
Oscillatory index (OSI) (%)
Time frame: 18 months
Flow helicity
Time frame: 18 months
Aortic inflow (L/min)
Time frame: 18 months
Aortic flow split (%)
Time frame: 18 months
Brachial arterial pressure (mmHg)
Time frame: 18 months
Mean and maximum arterial pressure (mmHg)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 19028056Marrocco-Trischitta MM, Melissano G, Kahlberg A, Calori G, Setacci F, Chiesa R. Chronic kidney disease classification stratifies mortality risk after elective stent graft repair of the thoracic aorta. J Vasc Surg. 2009 Feb;49(2):296-301. doi: 10.1016/j.jvs.2008.09.041. Epub 2008 Nov 22.
- Background: PubMed 27107487Bockler D, Brunkwall J, Taylor PR, Mangialardi N, Husing J, Larzon T; CTAG registry investigators. Thoracic Endovascular Aortic Repair of Aortic Arch Pathologies with the Conformable Thoracic Aortic Graft: Early and 2 year Results from a European Multicentre Registry. Eur J Vasc Endovasc Surg. 2016 Jun;51(6):791-800. doi: 10.1016/j.ejvs.2016.02.006. Epub 2016 Apr 20.
- Background: PubMed 25173340Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014 Nov 1;35(41):2873-926. doi: 10.1093/eurheartj/ehu281. Epub 2014 Aug 29. No abstract available.
- Background: PubMed 26798690van Bogerijen GH, Tolenaar JL, Conti M, Auricchio F, Secchi F, Sardanelli F, Moll FL, van Herwaarden JA, Rampoldi V, Trimarchi S. Contemporary Role of Computational Analysis in Endovascular Treatment for Thoracic Aortic Disease. Aorta (Stamford). 2013 Aug 1;1(3):171-81. doi: 10.12945/j.aorta.2013.13-003. eCollection 2013 Aug.
- Background: PubMed 15760265Ishimaru S. Endografting of the aortic arch. J Endovasc Ther. 2004 Dec;11 Suppl 2:II62-71. doi: 10.1177/15266028040110S614.
- Background: PubMed 28222992Marrocco-Trischitta MM, de Beaufort HW, Secchi F, van Bakel TM, Ranucci M, van Herwaarden JA, Moll FL, Trimarchi S. A geometric reappraisal of proximal landing zones for thoracic endovascular aortic repair according to aortic arch types. J Vasc Surg. 2017 Jun;65(6):1584-1590. doi: 10.1016/j.jvs.2016.10.113. Epub 2017 Feb 20.
- Background: PubMed 18460700Madhwal S, Rajagopal V, Bhatt DL, Bajzer CT, Whitlow P, Kapadia SR. Predictors of difficult carotid stenting as determined by aortic arch angiography. J Invasive Cardiol. 2008 May;20(5):200-4.
- Background: PubMed 20573524Molony DS, Kavanagh EG, Madhavan P, Walsh MT, McGloughlin TM. A computational study of the magnitude and direction of migration forces in patient-specific abdominal aortic aneurysm stent-grafts. Eur J Vasc Endovasc Surg. 2010 Sep;40(3):332-9. doi: 10.1016/j.ejvs.2010.06.001. Epub 2010 Jun 22.
- Background: PubMed 23395199Auricchio F, Conti M, Marconi S, Reali A, Tolenaar JL, Trimarchi S. Patient-specific aortic endografting simulation: from diagnosis to prediction. Comput Biol Med. 2013 May;43(4):386-94. doi: 10.1016/j.compbiomed.2013.01.006. Epub 2013 Feb 8.
- BackgroundAuricchio, F., Conti, M., Lefieux, A. et al. Comput Mech (2014) 54: 943. https://doi.org/10.1007/s00466-014-0976-6
- Background: PubMed 22561257Grabenwoger M, Alfonso F, Bachet J, Bonser R, Czerny M, Eggebrecht H, Evangelista A, Fattori R, Jakob H, Lonn L, Nienaber CA, Rocchi G, Rousseau H, Thompson M, Weigang E, Erbel R. Thoracic Endovascular Aortic Repair (TEVAR) for the treatment of aortic diseases: a position statement from the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2012 Jul;33(13):1558-63. doi: 10.1093/eurheartj/ehs074. Epub 2012 May 4. No abstract available.
- Background: PubMed 20199275Corbett TJ, Callanan A, O'Donnell MR, McGloughlin TM. An improved methodology for investigating the parameters influencing migration resistance of abdominal aortic stent-grafts. J Endovasc Ther. 2010 Feb;17(1):95-107. doi: 10.1583/09-2920.1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimiliano M Marrocco-Trischitta, MD,PhD contact
Massimiliano M Marrocco-Trischitta, MD,PhD principal investigator
Ospedale San Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Aneurysm and Aortic Dissection, run by Ospedale San Donato 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimiliano M Marrocco-Trischitta, MD,PhD (+393332084440, massimiliano.marroccotrischitta@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Displacement Force [magnitude (N)] (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT03824626, which also lists 15 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 22 Oct 2020.