CILCA Arch Registry: Management and Outcomes of Open and Endovascular Repair

NCT04995640 | Recruiting DMC

• 1 other identifier: 163/int/2020
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This registry aims to provide insights on the pathogenic mechanisms that expose subjects with CILCA arch to the increased risk of postoperative complications. So, the CILCA arch registry will capture clinical data and medical images of subjects with CILCA arch treated by surgical or endovascular (TEVAR) means. Study Design: International Multicenter and Observational registry Estimated Enrolment: 500 patients, with competitive enrolment. Clinical Follow up: Postoperatively at 30 days, at 12 months, and yearly after.

Conditions

Aortic Arch; Aortic Diseases; Bovine Arch

Keywords

TEVAR; bovine arch; endovascular treatment; open surgery; aortic arch variant; aortic arch

Outcome Measures

Primary Outcomes (6)

• Angulation of ascending aortic curvature

  Comparison among the Type of Arch (TOA), among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR) or Open repair

  From Admission to 5 years follow-up

• Arch angle

  Comparison among the TOA, among pre- and post-TEVAR or Open repair

  From Admission to 5 years follow-up

• Centerline curvature radius (mm)

  Comparison among the TOA, among pre- and post-TEVAR or Open repair

  From Admission to 5 years follow-up

• Outer curvature radius (mm)

  Comparison among the TOA, among pre- and post-TEVAR or Open repair

  From Admission to 5 years follow-up

• Centerline tortuosity

  Comparison among the TOA, among pre- and post-TEVAR or Open repair

  From Admission to 5 years follow-up

• Volume of the ascending aorta (cm3)

  Comparison among the TOA, among pre- and post-TEVAR or Open repair

  From Admission to 5 years follow-up

Secondary Outcomes (5)

• Area of proximal landing zones (PLZs, mm2)

  From Admission to 5 years follow-up

• Maximum diameter of PLZs (mm)

  From Admission to 5 years follow-up

• Arch length of PLZs (mm)

  From Admission to 5 years follow-up

• β angle of PLZs (°)

  From Admission to 5 years follow-up

• Tortuosity angle (°)

  From Admission to 5 years follow-up

Study Arms (1)

CILCA patients

Subject with a CILCA and a thoracic cardiovascular disease requiring treatment. Both open cardiovascular repair and endovascular treatment (TEVAR) will be included.

Procedure: open cardiovascular repair or endovascular treatment (TEVAR)

Interventions

open cardiovascular repair or endovascular treatment (TEVAR) PROCEDURE

Surgery type: open cardiovascular repair and endovascular treatment (TEVAR)

CILCA 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

Subject with a CILCA and a thoracic cardiovascular disease requiring treatment. Both open cardiovascular repair and endovascular treatment (TEVAR) will be included.

You may qualify if:

• Age ≥ 18 years old
• CILCA arch treated for an aortic disease (i.e. aortic dissection, aneurysm)

You may not qualify if:

• Contraindications to computed tomography (e.g. hypersensitivity to contrast media, renal failure);
• Suspected or manifested pregnancy

Sponsors & Collaborators

• Ospedale San Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

Related Publications (20)

• Moorehead PA, Kim AH, Miller CP, Kashyap TV, Kendrick DE, Kashyap VS. Prevalence of Bovine Aortic Arch Configuration in Adult Patients with and without Thoracic Aortic Pathology. Ann Vasc Surg. 2016 Jan;30:132-7. doi: 10.1016/j.avsg.2015.05.008. Epub 2015 Jul 10.

  PMID: 26166538 BACKGROUND

• Marrocco-Trischitta MM, Alaidroos M, Romarowski RM, Milani V, Ambrogi F, Secchi F, Glauber M, Nano G. Aortic arch variant with a common origin of the innominate and left carotid artery as a determinant of thoracic aortic disease: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2020 Mar 1;57(3):422-427. doi: 10.1093/ejcts/ezz277.

  PMID: 31620770 BACKGROUND

• Rylski B, Pacini D, Beyersdorf F, Quintana E, Schachner T, Tsagakis K, Ronchey S, Durko A, De Paulis R, Siepe M, Roselli EE, Carrel T, Czerny M, Schoenhoff FS; EACTS Vascular Domain, EJCTS and ICVTS Editorial Committees. Standards of reporting in open and endovascular aortic surgery (STORAGE guidelines). Eur J Cardiothorac Surg. 2019 Jul 1;56(1):10-20. doi: 10.1093/ejcts/ezz145.

  PMID: 31102528 BACKGROUND

• Marrocco-Trischitta MM, Romarowski RM, Alaidroos M, Sturla F, Glauber M, Nano G. Computational Fluid Dynamics Modeling of Proximal Landing Zones for Thoracic Endovascular Aortic Repair in the Bovine Arch Variant. Ann Vasc Surg. 2020 Nov;69:413-417. doi: 10.1016/j.avsg.2020.05.024. Epub 2020 May 29.

  PMID: 32479874 BACKGROUND

• Marrocco-Trischitta MM, Alaidroos M, Romarowski RM, Secchi F, Righini P, Glauber M, Nano G. Geometric Pattern of Proximal Landing Zones for Thoracic Endovascular Aortic Repair in the Bovine Arch Variant. Eur J Vasc Endovasc Surg. 2020 May;59(5):808-816. doi: 10.1016/j.ejvs.2019.11.019. Epub 2019 Dec 27.

  PMID: 31889656 BACKGROUND

• Popieluszko P, Henry BM, Sanna B, Hsieh WC, Saganiak K, Pekala PA, Walocha JA, Tomaszewski KA. A systematic review and meta-analysis of variations in branching patterns of the adult aortic arch. J Vasc Surg. 2018 Jul;68(1):298-306.e10. doi: 10.1016/j.jvs.2017.06.097. Epub 2017 Aug 31.

  PMID: 28865978 BACKGROUND

• Hornick M, Moomiaie R, Mojibian H, Ziganshin B, Almuwaqqat Z, Lee ES, Rizzo JA, Tranquilli M, Elefteriades JA. 'Bovine' aortic arch - a marker for thoracic aortic disease. Cardiology. 2012;123(2):116-24. doi: 10.1159/000342071. Epub 2012 Sep 28.

  PMID: 23037917 BACKGROUND

• Berko NS, Jain VR, Godelman A, Stein EG, Ghosh S, Haramati LB. Variants and anomalies of thoracic vasculature on computed tomographic angiography in adults. J Comput Assist Tomogr. 2009 Jul-Aug;33(4):523-8. doi: 10.1097/RCT.0b013e3181888343.

  PMID: 19638843 BACKGROUND

• Maxwell BG, Harrington KB, Beygui RE, Oakes DA. Congenital anomalies of the aortic arch in acute type-a aortic dissection: implications for monitoring, perfusion strategy, and surgical repair. J Cardiothorac Vasc Anesth. 2014 Jun;28(3):467-72. doi: 10.1053/j.jvca.2013.12.001. Epub 2014 Apr 14.

  PMID: 24731741 BACKGROUND

• Faggioli GL, Ferri M, Freyrie A, Gargiulo M, Fratesi F, Rossi C, Manzoli L, Stella A. Aortic arch anomalies are associated with increased risk of neurological events in carotid stent procedures. Eur J Vasc Endovasc Surg. 2007 Apr;33(4):436-41. doi: 10.1016/j.ejvs.2006.11.026. Epub 2007 Jan 19.

  PMID: 17240174 BACKGROUND

• Mylonas SN, Barkans A, Ante M, Wippermann J, Bockler D, Brunkwall JS. Prevalence of Bovine Aortic Arch Variant in Patients with Aortic Dissection and its Implications in the Outcome of Patients with Acute Type B Aortic Dissection. Eur J Vasc Endovasc Surg. 2018 Mar;55(3):385-391. doi: 10.1016/j.ejvs.2017.12.005. Epub 2018 Jan 12.

  PMID: 29338980 BACKGROUND

• Shalhub S, Schafer M, Hatsukami TS, Sweet MP, Reynolds JJ, Bolster FA, Shin SH, Reece TB, Singh N, Starnes BW, Jazaeri O. Association of variant arch anatomy with type B aortic dissection and hemodynamic mechanisms. J Vasc Surg. 2018 Dec;68(6):1640-1648. doi: 10.1016/j.jvs.2018.03.409. Epub 2018 May 24.

  PMID: 29804742 BACKGROUND

• Dumfarth J, Chou AS, Ziganshin BA, Bhandari R, Peterss S, Tranquilli M, Mojibian H, Fang H, Rizzo JA, Elefteriades JA. Atypical aortic arch branching variants: A novel marker for thoracic aortic disease. J Thorac Cardiovasc Surg. 2015 Jun;149(6):1586-92. doi: 10.1016/j.jtcvs.2015.02.019. Epub 2015 Feb 14.

  PMID: 25802134 BACKGROUND

• Altnji HE, Bou-Said B, Walter-Le Berre H. Morphological and stent design risk factors to prevent migration phenomena for a thoracic aneurysm: a numerical analysis. Med Eng Phys. 2015 Jan;37(1):23-33. doi: 10.1016/j.medengphy.2014.09.017. Epub 2014 Oct 22.

  PMID: 25456396 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; European Association for Cardio-Thoracic Surgery (EACTS); European Society of Cardiology (ESC); European Association of Percutaneous Cardiovascular Interventions (EAPCI). 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 J Cardiothorac Surg. 2012 Jul;42(1):17-24. doi: 10.1093/ejcts/ezs107. Epub 2012 May 4. No abstract available.

  PMID: 22561652 BACKGROUND

• Chen CK, Liang IP, Chang HT, Chen WY, Chen IM, Wu MH, Sheu MH, Shih CC. Impact on outcomes by measuring tortuosity with reporting standards for thoracic endovascular aortic repair. J Vasc Surg. 2014 Oct;60(4):937-44. doi: 10.1016/j.jvs.2014.04.008. Epub 2014 May 10.

  PMID: 24820894 BACKGROUND

• Ueda T, Takaoka H, Raman B, Rosenberg J, Rubin GD. Impact of quantitatively determined native thoracic aortic tortuosity on endoleak development after thoracic endovascular aortic repair. AJR Am J Roentgenol. 2011 Dec;197(6):W1140-6. doi: 10.2214/AJR.11.6819.

  PMID: 22109332 BACKGROUND

• Marrocco-Trischitta MM, van Bakel TM, Romarowski RM, de Beaufort HW, Conti M, van Herwaarden JA, Moll FL, Auricchio F, Trimarchi S. The Modified Arch Landing Areas Nomenclature (MALAN) Improves Prediction of Stent Graft Displacement Forces: Proof of Concept by Computational Fluid Dynamics Modelling. Eur J Vasc Endovasc Surg. 2018 Apr;55(4):584-592. doi: 10.1016/j.ejvs.2017.12.019. Epub 2018 Feb 6.

  PMID: 29426592 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

• Marrocco-Trischitta MM, Romarowski RM, de Beaufort HW, Conti M, Vitale R, Secchi F, Auricchio F, Trimarchi S. The Modified Arch Landing Areas Nomenclature identifies hostile zones for endograft deployment: a confirmatory biomechanical study in patients treated by thoracic endovascular aortic repairdagger. Eur J Cardiothorac Surg. 2019 May 1;55(5):990-997. doi: 10.1093/ejcts/ezy409.

  PMID: 30535119 BACKGROUND

MeSH Terms

Conditions

Aortic Diseases

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Massimiliano Maria Marrocco-Trischitta, MD, PhD

  Ospedale San Donato , IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimiliano Maria Marrocco-Trischitta, MD, PhD

CONTACT

+390252774695; Massimiliano.MarroccoTrischitta@grupposandonato.it

Irene Baroni, RN, MSc

CONTACT

+390252774690; RicercaClinica.PSD@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular surgeon

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: August 9, 2021
• Study Start: October 1, 2021
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)