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临床试验/NCT03600077
NCT03600077已完成不适用

Evaluation of Supra-aortic Trunks Debranching Techniques in Open Arch Repair by Means of Frozen Elephant Trunk Procedure With Two Configurations of the Jotec E-Vita Hybrid Graft

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
antegrade cerebral perfusion time (minutes)

研究概览

简要总结

To evaluate two different supra-aortic trunks debranching techniques during open repair of aortic arch aneurysms by means of Frozen Elephant Trunk procedure with two configurations of the Jotec E-Vita hybrid graft.

详细描述

Open management of extensive pathology of the proximal aorta, namely ascending aorta, aortic arch, and descending thoracic aorta (DTA) requires sequential treatment of each segment involved. According to the etiopathogenesis and clinical history of the disease, each segment can be treated independently or in association with the other portions of diseased aorta.

The current standard of treatment for arch aneurysmal disease extending into the DTA is the elephant trunk technique: both conventional and "frozen". The first requires open repair of the aortic arch with the use of a conventional surgical graft which distal end is left dangling in the DTA and will be the site of the proximal anastomosis of the subsequent repair of the thoracic aneurysm. The frozen elephant trunk (FET) technique differs from the first for the graft employed: this graft has a distal stented portion which is deployed in the DTA and facilitates subsequent endovascular management of the thoracic pathology.

In both the conventional elephant trunk and frozen elephant trunk the supra-aortic trunks (innominate artery, left carotid artery and left subclavian artery) need to be reimplanted on the surgical graft with variable configurations.

Debranching and reimplantation of such vessels can occur with variable configurations and either before or after the substitution of the pathologic aorta which is performed during cardiac arrest and extra-corporeal circulation (ECC) The first design has a straight tubual graft with self-expanding stents in the distal portion and has been employed at department of Vascular Surgery in San Raffaele Hospital, from December 2009 to February 2016. The second design has two side-branches on the non-stented proximal portion which facilitate debranching of the supra-aortic trunks before cardiac arrest and allow early reperfusion of the visceral vessels during extra-corporeal circulation . This graft has been introduced in practice at department of Vascular Surgery at San Raffaele Hospital in November 2016.

The investigators review a prospectively compiled Microsoft Office Excel database with the procedural details of the 30 patients affected by extensive proximal aortic pathology treated at department of Vascular Surgery in San Raffaele Hospital between December 2009 and January 2017 by means of Frozen Elephant Trunk technique, and of those of the next 20 patients who will be treated with the same procedure.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient undergoing treatment of extensive proximal aortic pathology at San Raffaele Hospital since December 2009

排除标准

  • extensive proximal aortic pathology treated by techniques other than frozen elephant trunk : total open aortic repair, total endovascular aortic repair, hybrid endovascular aortic repair in zone 0.

结局指标

主要结局

antegrade cerebral perfusion time (minutes)

时间窗: Intraoperative

- antegrade cerebral perfusion time

Extracorporeal circulation times (minutes)

时间窗: Intraoperative

- Extracorporeal circulation time

Lower limb perfusion time (minutes)

时间窗: Intraoperative

- Lower limb perfusion time

次要结局

  • Clinical 30-day results (Percent of participants with the clinical outcome)(Perioperative, 30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bertoglio Luca

Principal Investigator

IRCCS San Raffaele

研究点 (1)

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