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临床试验/NCT03342755
NCT03342755已完成不适用

Evaluation of STaged Endovascular Aneurysm Repair in the Management of Thoracoabdominal Pathology by Means of Branched and Fenestrated Devices.(STEAR)

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年11月21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
Prevention of rupture of aortic aneurysm or other aortic pathology

研究概览

简要总结

The study aims to analyzing the impact of the staged endovascular treatment (divided into two or more distinct procedures) of thoracoabdominal aneurysmatic pathology on short and medium term, technical and clinical outcomes and on the possible benefits or complications associated with this approach.

详细描述

Since the development of custom-made fenestrated and branched endografts a novel therapeutic option for the management of thoracoabdominal aortic aneurysms was made accessible. In order to achieve complete aneurysm exclusion more than one endovascular graft is usually needed according to device characteristics and aneurysm extent. Usually a straight tube graft is initially placed in the proximal descending aorta, followed by a custom-made device for the visceral abdominal aorta, and completed with a bifurcated infrarenal graft landing at the level of the common iliac arteries. Many variations are available according to patient anatomy, pathology, and previous aortic surgeries.

The different components required can be deployed in the patient in one setting (i.e. single-stage endovascular repair) or across more than one surgeries (i.e. multi-stage endovascular repair), depending on procedural needs and surgeon choice. According to limited reported series the latter option seems to be associated to better clinical outcomes both in terms of spinal cord ischemia and overall survival.

In addition to the number, type and order of stages required for patient treatment, primary and secondary end-points are the evaluation of the short-term (6 months) and mid-term (5 years) outcomes as illustrated in the Society for Vascular Surgery reporting standards for TEVAR.

The investigators review a prospectively compiled Microsoft Office Excel database with the procedural details of the 47 patients treated at our Institution between October 2013 and October 2017 by means of total endovascular thoracoabdominal aortic aneurysm repair and of those of the next 50 patients which will be treated until December 2020. All patients will be recorded together with their characteristics and number and type of stages required for treatment completion.

All enrolled patients will be contact yearly by phone, in addition to standard follow-up imaging, to confirm persistence of technical and clinical success and to evaluate the eventual onset of any treatment related complication or disease evolution Possible stage types will be differentiated as: proximal thoracic component (TEVAR), visceral component (Custom-Made), bifurcated component (EVAR), iliac extensions, iliac branch devices.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • patient with ≥ 18 years of age, undergoing total endovascular treatment of thoracoabdominal pathology (single-stage or multi-stage endovascular repair) at San Raffaele Hospital in between October 2013 and December 2020.

排除标准

  • 未提供

结局指标

主要结局

Prevention of rupture of aortic aneurysm or other aortic pathology

时间窗: between October 2013 and December 2020

Prevention of death from aneurysm rupture or other aortic pathology (including end-organ ischemia)

时间窗: between October 2013 and December 2020

Prevention of death associated with primary or secondary treatment of the original aortic pathology, including operative or endovascular intervention for rupture, dissection, or end-organ ischemia

时间窗: between October 2013 and December 2020

次要结局

  • New, expanding, or progressing: aneurysm, dissection, ulceration, or hematoma(between October 2013 and December 2020)
  • Device migration,degradation (eg, stent fracture, fabric erosion);(between October 2013 and December 2020)
  • Endoleak presence (for aneurysm),Endoleak requiring intervention(between October 2013 and December 2020)

研究者

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

Bertoglio Luca

MD

IRCCS San Raffaele

研究点 (1)

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