CILCA Registry: Aortic Arch Variant With a Common Origin of the Innominate and Left Carotid Artery. Management and Outcomes of Open and Endovascular Repair.

Ospedale San Donato1 个研究点分布在 1 个国家目标入组 500 人开始时间: 2021年10月1日最近更新: 2021年9月29日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Ospedale San Donato
入组人数: 500
试验地点: 1
主要终点: Angulation of ascending aortic curvature

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

Technical and specific aims:

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Other

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

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

排除标准

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