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Biomechanical Reappraisal of Planning for Thoracic Endovascular Aortic Repair (MALAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03824626
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
University of Pavia
Information provided by (Responsible Party):
Massimiliano M. Marrocco-Trischitta, Ospedale San Donato

Brief 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. 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.

Condition or disease Intervention/treatment
Thoracic Aortic Aneurysm Aortic Dissection Aortic Diseases Diagnostic Test: TEVAR patients

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mapping of Aortic Arch Hemodynamics by Biomechanical Analysis and Modeling for Planning Thoracic Endovascular Aortic Repair
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TEVAR patients
patients scheduled for thoracic endovascular aortic repair
Diagnostic Test: TEVAR patients
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.
Other Name: CTA and pc-MRI




Primary Outcome Measures :
  1. 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)

  2. Displacement Force [Vector (-)] [ Time Frame: 18 months ]
    Comparison among the Type of Arch (TOA); Comparison among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR)


Secondary Outcome Measures :
  1. Area of proximal landing zones (PLZs) (mm2) [ Time Frame: 18 months ]
    Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR

  2. Equivalent Surface Traction (EST) (N/ mm2) [ Time Frame: 18 months ]
    Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR

  3. Radius of curvature (1/mm) [ Time Frame: 18 months ]
    Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR

  4. Angulation (tangent angle function) [ Time Frame: 18 months ]
    Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR

  5. Tortuosity (tortuosity angle function) [ Time Frame: 18 months ]
    Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR

  6. Mean and maximum flow velocity magnitude (cm/sec) in aortic along the cardiac cycle [ Time Frame: 18 months ]
    Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR

  7. Systolic wall shear stress (dyn/cm2) [ Time Frame: 18 months ]
    Comparison among the TOA and PLZs

  8. Time-averaged wall shear stress (TAWSS) (dyn/cm2) [ Time Frame: 18 months ]
    Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR

  9. Oscillatory index (OSI) (%) [ Time Frame: 18 months ]
    Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR

  10. Flow helicity [ Time Frame: 18 months ]
    Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR

  11. Aortic inflow (L/min) [ Time Frame: 18 months ]
    Comparison among the TOA; Comparison among pre- and post-TEVAR

  12. Aortic flow split (%) [ Time Frame: 18 months ]
    Comparison among the TOA; Comparison among pre- and post-TEVAR

  13. Brachial arterial pressure (mmHg) [ Time Frame: 18 months ]
    Comparison among the TOA; Comparison among pre- and post-TEVAR

  14. Mean and maximum arterial pressure (mmHg) [ Time Frame: 18 months ]
    Comparison among the TOA; Comparison among pre- and post-TEVAR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824626


Contacts
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Contact: Massimiliano M Marrocco-Trischitta, MD,PhD +393332084440 massimiliano.marroccotrischitta@grupposandonato.it
Contact: Irene Baroni, RN,MSc +39025277 ext 4690 irene.baroni@grupposandonato.it

Locations
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Italy
IRCCS Policlinico San Donato Recruiting
San Donato Milanese, Milan, Italy, 20097
Contact: Massimiliano M Marrocco Trischitta, MD    (+39) 025277 ext 4344    Massimiliano.MarroccoTrischitta@grupposandonato.it   
Sponsors and Collaborators
Ospedale San Donato
University of Pavia
Investigators
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Principal Investigator: Massimiliano M Marrocco-Trischitta, MD,PhD Ospedale San Donato
Publications:
Auricchio, F., Conti, M., Lefieux, A. et al. Comput Mech (2014) 54: 943. https://doi.org/10.1007/s00466-014-0976-6
Elena 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

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Responsible Party: Massimiliano M. Marrocco-Trischitta, Vascular Surgeon, Principal Investigator, Doctor of Medicine and of Philosophy, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT03824626    
Other Study ID Numbers: 160/int/2017
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Massimiliano M. Marrocco-Trischitta, Ospedale San Donato:
thoracic endovascular aortic repair
computational fluid dynamics
preoperative planning
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases