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

NCT ID: NCT04995640

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2026-04-15

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.

Detailed Description

The so-called "bovine" aortic arch (BAA) is characterized by the presence of a common origin of the innominate and left carotid artery, or, less frequently, by the origin of the left carotid directly from the innominate artery (i.e. type 2 BAA). In the present protocol, for brevity and according to the STROBE guidelines the investigators employed the acronym CILCA (common origin of the innominate and left carotid artery) arch, previously employed in publications of our group.

The CILCA is the second more common arch configuration, and its prevalence in the general population is 13.6%, with relevant differences among ethnic groups. However, the real prevalence of the CILCA is likely underestimated, because its presence is largely unreported due to the presumed clinical irrelevance of this anatomical variant. In fact, the peculiar anatomical features associated with the CILCA mandate specific management strategies and preoperative planning in both surgical and endovascular procedures involving the aortic arch, including type A aortic dissection repair and carotid stenting.

There is increasing evidence in the literature that the CILCA represents a potential determinant of the onset of thoracic aortic disease. Notably, it is associated with a 1.4-fold increased risk of developing aortic aneurysms or dissections, and this entails a relevant prevalence of this anatomical variant among patients requiring thoracic endovascular aortic repair (TEVAR). In fact, the CILCA presents a consistent and peculiar anatomical pattern compared with standard arch configuration, which provides relevant information for TEVAR planning, and may have prognostic implications.

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.

Technical and specific aims:

• Development of automatic segmentation of medical images for the assessment of geometric features by machine learning
• Assessment of a simplified method for the calculation of the "displacement forces" in proximal landing zones for TEVAR

Primary Endpoint: Identification of peculiar anatomical characteristics in patients with CILCA arch, before\after treatment of aortic pathologies (including both TEVAR and Open Repair).

Secondary Endpoint: Identification of anatomical risk factors for the postoperative clinical outcomes.

REGISTRY DESIGN International Multicenter and Observational clinical registry. Enrollment will include 500 patients with CILCA arch, treated with TEVAR or open repair. All patients will be followed up for 5 years, and their' clinical pathway and treatment strategy will be at discretion of the operator following current guidelines for thoracic aortic disease.

FOLLOW-UP PERIOD Postoperatively, patients will be followed-up for 5 years. This includes every medical check-up performed according to clinical practice (including telephone contacts) to obtain information regarding medical history, cardiovascular drugs use, hospitalizations, and adverse events, at 30 days, at 12 months, and yearly after. Repeated imaging (i.e. CT scan or magnetic resonance imaging) will be obtained according to current guidelines, or medical need.

STATISTICAL ANALYSIS All patients who are successfully registered will be included in the analysis. Being this an observational registry aiming to investigate the postoperative outcomes of patients with CILCA, the investigators proceeded without a formal power analysis. The number of patients scheduled to be enrolled (i.e. 500) was deemed adequate to provide robust evidence for future statistical analyses.

The study will be performed according to "good clinical practice ". The collection of personal, procedural and clinical data of patients must take place into the electronic CRF. Only the investigators and the personnel registered on the "Site Personnel Signature Log" will be granted access to the eCRF.

.

Conditions

Aortic Arch; Aortic Diseases; Bovine Arch

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

CILCA patients

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

open cardiovascular repair or endovascular treatment (TEVAR)

Intervention Type: PROCEDURE

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

Interventions

open cardiovascular repair or endovascular treatment (TEVAR)

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale San Donato

OTHER

Sponsor Role: lead

Responsible Party

Massimiliano M. Marrocco-Trischitta

Vascular surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimiliano Maria Marrocco-Trischitta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Donato , IRCCS

Locations

IRCCS Policlinico San Donato

San Donato Milanese, Milan, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Massimiliano Maria Marrocco-Trischitta, MD, PhD

Role: CONTACT

Massimiliano.MarroccoTrischitta@grupposandonato.it

+390252774695

Irene Baroni, RN, MSc

Role: CONTACT

RicercaClinica.PSD@grupposandonato.it

+390252774690

Facility Contacts

Massimiliano M Marrocco Trischitta, MD

Role: primary

Massimiliano.MarroccoTrischitta@grupposandonato.it

(+39) 025277 ext. 4344

References

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.

Reference Type: BACKGROUND

PMID: 26166538 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31620770 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31102528 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32479874 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31889656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28865978 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23037917 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19638843 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24731741 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17240174 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29338980 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29804742 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25802134 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25456396 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22561652 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24820894 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22109332 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29426592 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28222992 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30535119 (View on PubMed)

Other Identifiers

163/int/2020

Identifier Type: -

Identifier Source: org_study_id