An observational study in Aortic Arch, Aortic Diseases and Bovine Arch, sponsored by Ospedale San Donato. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by Ospedale San Donato · Observational
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.
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:
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.
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108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.
This study's planned enrollment of 500 is above the median of 186 across 62 observational studies indexed under Aortic Diseases.
Browse Aortic Diseases studies →Ospedale San Donato is the lead sponsor of 27 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Subject with a CILCA and a thoracic cardiovascular disease requiring treatment. Both open cardiovascular repair and endovascular treatment (TEVAR) will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Surgery type: open cardiovascular repair and endovascular treatment (TEVAR)
Angulation of ascending aortic curvature
Comparison among the Type of Arch (TOA), among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR) or Open repair
Time frame: From Admission to 5 years follow-up
Arch angle
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Time frame: From Admission to 5 years follow-up
Centerline curvature radius (mm)
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Time frame: From Admission to 5 years follow-up
Outer curvature radius (mm)
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Time frame: From Admission to 5 years follow-up
Centerline tortuosity
Comparison among the TOA, among pre- and post-TEVAR or Open repair
Time frame: 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
Time frame: From Admission to 5 years follow-up
Area of proximal landing zones (PLZs, mm2)
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From Admission to 5 years follow-up
Tortuosity angle (°)
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
Time frame: From Admission to 5 years follow-up
Plan to share: No
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