Aortic ArchNCT04995640
CILCA Arch Registry: Management and Outcomes of Open and Endovascular Repair
An observational study of Aortic Arch and Aortic Diseases, run by Ospedale San Donato at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Arch, Aortic Diseases, Bovine Arch
- What is being tested?
- open cardiovascular repair or endovascular treatment (TEVAR)
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2021to 15 Apr 2026
- 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: Subject with a CILCA and a thoracic cardiovascular disease requiring treatment. Both open cardiovascular repair and endovascular treatment (TEVAR) will be included.
Who may be able to join
- Age ≥ 18 years old
- CILCA arch treated for an aortic disease (i.e. aortic dissection, aneurysm)
Who cannot join
- Contraindications to computed tomography (e.g. hypersensitivity to contrast media, renal failure);
- Suspected or manifested pregnancy
Trial locations and contacts
1 site in 1 country.
Massimiliano Maria 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: CILCA Registry: Aortic Arch Variant With a Common Origin of the Innominate and Left Carotid Artery. Management and Outcomes of Open and Endovascular Repair.
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.
Read the 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
- Being tested
- open cardiovascular repair or endovascular treatment (TEVAR)
- Keywords
- TEVAR, bovine arch, endovascular treatment, open surgery, aortic arch variant, aortic arch
- Medical subject headings
- Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open cardiovascular repair or endovascular treatment (TEVAR)Procedure or surgery
Surgery type: open cardiovascular repair and endovascular treatment (TEVAR)
| Study group | Role | What they receive |
|---|---|---|
| CILCA patients | Subject with a CILCA and a thoracic cardiovascular disease requiring treatment. Both open cardiovascular repair and endovascular treatment (TEVAR) will be included. Receives: Procedure: open cardiovascular repair or endovascular treatment (TEVAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angulation of ascending aortic curvature
Comparison among the Type of Arch (TOA), among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR) or Open repair
Measured: From Admission to 5 years follow-up
Arch angle
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Measured: From Admission to 5 years follow-up
Centerline curvature radius (mm)
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Measured: From Admission to 5 years follow-up
Outer curvature radius (mm)
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Measured: From Admission to 5 years follow-up
Centerline tortuosity
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Measured: 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
Measured: From Admission to 5 years follow-up
Secondary outcomes (5)
Area of proximal landing zones (PLZs, mm2)
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
Measured: From Admission to 5 years follow-up
Maximum diameter of PLZs (mm)
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
Measured: From Admission to 5 years follow-up
Arch length of PLZs (mm)
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
Measured: From Admission to 5 years follow-up
β angle of PLZs (°)
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
Measured: From Admission to 5 years follow-up
Tortuosity angle (°)
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
Measured: From Admission to 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Oct 2021 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Aortic ArchStudies 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
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano M. Marrocco-Trischitta, Ospedale San Donato
- Investigators
- Massimiliano Maria Marrocco-Trischitta, MD, PhD, Principal investigator, Ospedale San Donato , IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995640
- Sponsor's protocol ID
- 163/int/2020
- Status last verified
- Sep 2021
- First submitted
- 29 Mar 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26166538Marrocco-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.
PubMed 31620770Rylski 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.
PubMed 31102528Marrocco-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.
PubMed 32479874Marrocco-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.
PubMed 31889656Popieluszko 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.
PubMed 28865978Hornick 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.
PubMed 23037917Berko 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.
PubMed 19638843Maxwell 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.
PubMed 24731741Faggioli 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.
PubMed 17240174Mylonas 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.
PubMed 29338980Shalhub 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.
PubMed 29804742Dumfarth 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.
PubMed 25802134Altnji 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.
PubMed 25456396Grabenwoger 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.
PubMed 22561652
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CILCA Registry: Aortic Arch Variant With a Common Origin of the Innominate and Left Carotid Artery. Management and Outcomes of Open and Endovascular Repair.
- ClinicalTrials.gov ID
- NCT04995640
- Acronym / sponsor ID
- 163/int/2020
- Conditions
- Aortic Arch, Aortic Diseases, Bovine Arch
- Keywords
- TEVAR, bovine arch, endovascular treatment, open surgery, aortic arch variant, aortic arch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 9 Aug 2021 (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.
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.
.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CILCA patients | – | Procedure: open cardiovascular repair or endovascular treatment (TEVAR)Subject with a CILCA and a thoracic cardiovascular disease requiring treatment. Both open cardiovascular repair and endovascular treatment (TEVAR) will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with a CILCA and a thoracic cardiovascular disease requiring treatment. Both open cardiovascular repair and endovascular treatment (TEVAR) will be included.
Key inclusion criteria (2 listed)
- Age ≥ 18 years old
- CILCA arch treated for an aortic disease (i.e. aortic dissection, aneurysm)
Key exclusion criteria (2 listed)
- Contraindications to computed tomography (e.g. hypersensitivity to contrast media, renal failure);
- Suspected or manifested pregnancy
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 |
|---|---|---|
| open cardiovascular repair or endovascular treatment (TEVAR)Surgery type: open cardiovascular repair and endovascular treatment (TEVAR) | Procedure or surgery | CILCA patients |
Primary outcome
Angulation of ascending aortic curvature
Time frame: From Admission to 5 years follow-up
Comparison among the Type of Arch (TOA), among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR) or Open repair
Arch angle
Time frame: From Admission to 5 years follow-up
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Centerline curvature radius (mm)
Time frame: From Admission to 5 years follow-up
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Outer curvature radius (mm)
Time frame: From Admission to 5 years follow-up
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Centerline tortuosity
Time frame: From Admission to 5 years follow-up
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Volume of the ascending aorta (cm3)
Time frame: From Admission to 5 years follow-up
Comparison among the TOA, among pre- and post-TEVAR or Open repair
5 secondary outcomes
Area of proximal landing zones (PLZs, mm2)
Time frame: From Admission to 5 years follow-up
Maximum diameter of PLZs (mm)
Time frame: From Admission to 5 years follow-up
Arch length of PLZs (mm)
Time frame: From Admission to 5 years follow-up
β angle of PLZs (°)
Time frame: From Admission to 5 years follow-up
Tortuosity angle (°)
Time frame: From Admission to 5 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 26166538Moorehead 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.
- Background: PubMed 31620770Marrocco-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.
- Background: PubMed 31102528Rylski 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.
- Background: PubMed 32479874Marrocco-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.
- Background: PubMed 31889656Marrocco-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.
- Background: PubMed 28865978Popieluszko 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.
- Background: PubMed 23037917Hornick 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.
- Background: PubMed 19638843Berko 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.
- Background: PubMed 24731741Maxwell 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.
- Background: PubMed 17240174Faggioli 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.
- Background: PubMed 29338980Mylonas 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.
- Background: PubMed 29804742Shalhub 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.
- 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 Maria Marrocco-Trischitta, MD, PhD contact
Massimiliano Maria Marrocco-Trischitta, MD, PhD principal investigator
Ospedale San Donato , IRCCS
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 Aortic Arch and Aortic Diseases, 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 2 inclusion and 2 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 29 Sep 2021. 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 Maria Marrocco-Trischitta, MD, PhD (+390252774695, Massimiliano.MarroccoTrischitta@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angulation of ascending aortic curvature (time frame: From Admission to 5 years follow-up). The study lists 6 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 NCT04995640, which also lists 20 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 29 Sep 2021.