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

September 28, 2021 updated by: Massimiliano M. Marrocco-Trischitta, Ospedale San Donato

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Milan
      • San Donato Milanese, Milan, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Surgery type: open cardiovascular repair and endovascular treatment (TEVAR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From Admission to 5 years follow-up
Arch angle
Time Frame: From Admission to 5 years follow-up
Comparison among the TOA, among pre- and post-TEVAR or Open repair
From Admission to 5 years follow-up
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
From Admission to 5 years follow-up
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
From Admission to 5 years follow-up
Centerline tortuosity
Time Frame: From Admission to 5 years follow-up
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)
Time Frame: From Admission to 5 years follow-up
Comparison among the TOA, among pre- and post-TEVAR or Open repair
From Admission to 5 years follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of proximal landing zones (PLZs, mm2)
Time Frame: From Admission to 5 years follow-up
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
From Admission to 5 years follow-up
Maximum diameter of PLZs (mm)
Time Frame: From Admission to 5 years follow-up
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
From Admission to 5 years follow-up
Arch length of PLZs (mm)
Time Frame: From Admission to 5 years follow-up
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
From Admission to 5 years follow-up
β angle of PLZs (°)
Time Frame: From Admission to 5 years follow-up
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
From Admission to 5 years follow-up
Tortuosity angle (°)
Time Frame: From Admission to 5 years follow-up
Comparison among the TOA and PLZs; comparison among pre- and post-TEVAR or Open repair
From Admission to 5 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Donato

Investigators

  • Principal Investigator: Massimiliano Maria Marrocco-Trischitta, MD, PhD, Ospedale San Donato , IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2021

Primary Completion (ANTICIPATED)

April 15, 2026

Study Completion (ANTICIPATED)

April 15, 2026

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (ACTUAL)

August 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 163/int/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Diseases

Clinical Trials on open cardiovascular repair or endovascular treatment (TEVAR)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe