Biomechanical Reappraisal of Planning for Thoracic Endovascular Aortic Repair

NCT03824626 | Unknown

• 1 other identifier: 160/int/2017
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Aortic Aneurysm; Aortic Dissection; Aortic Diseases

Keywords

thoracic endovascular aortic repair; computational fluid dynamics; preoperative planning

Outcome Measures

Primary Outcomes (2)

• Displacement Force [magnitude (N)]

  Comparison among the Type of Arch (TOA); Comparison among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR)

  18 months

• Displacement Force [Vector (-)]

  Comparison among the Type of Arch (TOA); Comparison among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR)

  18 months

Secondary Outcomes (14)

• Area of proximal landing zones (PLZs) (mm2)

  18 months

• Equivalent Surface Traction (EST) (N/ mm2)

  18 months

• Radius of curvature (1/mm)

  18 months

• Angulation (tangent angle function)

  18 months

• Tortuosity (tortuosity angle function)

  18 months

Study Arms (1)

TEVAR patients

patients scheduled for thoracic endovascular aortic repair

Diagnostic Test: TEVAR patients

Interventions

TEVAR patients DIAGNOSTIC_TEST

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.

Also known as: CTA and pc-MRI

TEVAR patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale San Donato: lead
• University of Pavia: collaborator

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

Related Publications (15)

• 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.

  PMID: 19028056 BACKGROUND

• Bockler 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.

  PMID: 27107487 BACKGROUND

• Erbel 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.

  PMID: 25173340 BACKGROUND

• van 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.

  PMID: 26798690 BACKGROUND

• Ishimaru S. Endografting of the aortic arch. J Endovasc Ther. 2004 Dec;11 Suppl 2:II62-71. doi: 10.1177/15266028040110S614.

  PMID: 15760265 BACKGROUND

• Marrocco-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.

  PMID: 28222992 BACKGROUND

• Madhwal 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.

  PMID: 18460700 BACKGROUND

• Molony 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.

  PMID: 20573524 BACKGROUND

• Auricchio 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.

  PMID: 23395199 BACKGROUND

• Auricchio, F., Conti, M., Lefieux, A. et al. Comput Mech (2014) 54: 943. https://doi.org/10.1007/s00466-014-0976-6

  BACKGROUND

• 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.

  PMID: 22561257 BACKGROUND

• Corbett 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.

  PMID: 20199275 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16549092 BACKGROUND

• Gillen 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.

  PMID: 25449008 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aortic Dissection; Aortic Diseases

Interventions

Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Massimiliano M Marrocco-Trischitta, MD,PhD

  Ospedale San Donato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimiliano M Marrocco-Trischitta, MD,PhD

CONTACT

+393332084440; massimiliano.marroccotrischitta@grupposandonato.it

Irene Baroni, RN,MSc

CONTACT

+39025277; irene.baroni@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon, Principal Investigator, Doctor of Medicine and of Philosophy

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 31, 2019
• Study Start: May 23, 2019
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)