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临床试验/NCT06373393
NCT06373393Enrolling By Invitation不适用

SPIRIT: Study of the Patency of Spinal aRteries After the STABILISE Technique

Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
1
主要终点
number of patent intercostal and lumbar arteries

研究概览

简要总结

The aim of the study is to evaluate the impact of the stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair (STABILISE) technique in the patency of intercostal and lumbar arteries detectable on computed tomography angiography (CTA) in patients with type B aortic dissection and its correlation with the occurrence of spinal cord ischaemia (SCI).

Primary end-point: patency of the intercostal and lumbar arteries on follow-up CTA.

Secondary end-point: spinal cord ischaemia

详细描述

BACKGROUND AND STUDY INTRODUCTION

Endovascular treatment emerged over the last decade as the standard of care for complicated acute type B aortic dissection and the first step is usually the deployment of a thoracic endograft (TEVAR) aiming to cover the entry tear. TEVAR may be enough to fix malperfusion syndromes but is frequently associated with late aortic dilatation and unfavorable remodeling [1,2]. The failure of simple TEVAR to solve malperfusion syndromes led to the development of adjunctive techniques like direct stenting of the occluded arteries, fenestration of the lamella or the association of a self-expandable bare stent deployment across the visceral and renal arteries to increase the true lumen diameter and improve perfusion of those arteries.

The STABILISE technique to treat type B dissections is able to disrupt the lamella of the dissected aorta and consequently restore the uniluminal state of the aortic anatomy [3,4,5].

The dissection process is related to the detachment of the aortic side branch ostia (visceral, renal, iliacs, intercostals, lumbars) and therefore a potential status of malperfusion which is often related to severe clinical complications that should be properly managed. Additionally, when the lamella is brought back to the peripheral aortic wall, according to the STABILISE concept, the recovery of perfusion from the true lumen is unclear.

All these mechanisms, as well as the cover of the ostia of upper intercostal arteries by the stentgraft, may compromise the intercostal and lumbar arteries patency or the direct flow from the true lumen and therefore be related to the occurrence of spinal cord ischemia complications which prevalence was not yet determined [6-10].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with type B dissection treated according to the STABILISE technique

排除标准

  • Aortic rupture.

结局指标

主要结局

number of patent intercostal and lumbar arteries

时间窗: baseline (pre op) and 1, 6, 12 and 24 months after surgery

number of patent intercostal and lumbar arteries after STABILISE

次要结局

  • number of patients with spinal cord ischemia(baseline (pre op) and 1month after surgery)

研究者

发起方
Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
申办方类型
Other
责任方
Sponsor

研究点 (1)

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