涉及左锁骨下动脉的主动脉疾病患者体外开窗术和原位开窗术的安全性与有效性：一项前瞻性、单中心、随机对照研究。
Safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery: a prospective, single-center, randomized controlled study.
作者信息
Jia Xiaojian, Wu Jingjin, Ding Caiyou, Lou Yanbo
机构信息
Department of Vascular Surgery, The Fourth Affiliated Hospital, Zhejiang University School of Medicine, Yiwu, Zhejiang, China.
出版信息
Trials. 2025 Jan 30;26(1):33. doi: 10.1186/s13063-025-08746-5.
BACKGROUND
Thoracic aortic pathologies involving the aortic arch are a great challenge for vascular surgeons. Maintaining the patency of supra-aortic branches while excluding the aortic lesion remains difficult. Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations provides a feasible and effective approach for this type of disease. The main purpose of this trial is to assess the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.
METHODS
This is a prospective, single-center, randomized controlled study. A total of 170 eligible patients will be recruited from The Fourth Affiliated Hospital, Zhejiang University School of Medicine in China and randomized on a 1:1 basis either to the group A (extracorporeal fenestration) or the group B (in situ fenestration). The primary outcome will be the all-cause mortality (30 days). The secondary outcomes will include incidence of secondary intervention (30 days, 6 months, 1 year), incidence of endoleak (30 days, 6 months, 1 year), incidence of major adverse events (MAE) (i.e., immediate procedural success and complications) (30 days, 6 months, 1 year), immediate technical success rate, and all-cause mortality (6 months, 1 year).
DISCUSSION
Suppose extracorporeal fenestration non-inferior to in situ fenestration in patients with aortic disease involving the left subclavian artery. This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery, which is expected to provide a reference for Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations.
TRIAL REGISTRATION
ClinicalTrials.gov NCT06256757. Registered on February 5, 2024. https://clinicaltrials.gov/study/NCT06256757 .
背景
涉及主动脉弓的胸主动脉病变对血管外科医生来说是巨大挑战。在排除主动脉病变的同时保持主动脉弓上分支的通畅仍然困难。带开窗的胸主动脉腔内修复术（TEVAR）为这类疾病提供了一种可行且有效的方法。本试验的主要目的是评估体外开窗和原位开窗在累及左锁骨下动脉的主动脉疾病患者中的安全性和有效性。
方法
这是一项前瞻性、单中心、随机对照研究。将从中国浙江大学医学院附属第四医院招募总共170名符合条件的患者，并按1:1比例随机分为A组（体外开窗）或B组（原位开窗）。主要结局将是全因死亡率（30天）。次要结局将包括二次干预发生率（30天、6个月、1年）、内漏发生率（30天、6个月、1年）、主要不良事件（MAE）发生率（即手术即刻成功和并发症）（30天、6个月、1年）、即刻技术成功率以及全因死亡率（6个月、1年）。
讨论
假设在累及左锁骨下动脉的主动脉疾病患者中体外开窗不劣于原位开窗。本试验旨在证明体外开窗和原位开窗在累及左锁骨下动脉的主动脉疾病患者中的安全性和有效性，有望为带开窗的胸主动脉腔内修复术（TEVAR）提供参考。
试验注册
ClinicalTrials.gov NCT06256757。于2024年2月5日注册。https://clinicaltrials.gov/study/NCT06256757 。
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