跳至主要内容
临床试验/NCT07118995
NCT07118995进行中(未招募)不适用

Anatomical Feasibility of the Braile Off-the-Shelf Multi-Branched Endograft for the Treatment of Thoracoabdominal Aneurysm

Braile Biomedica Ind. Com. e Repr. Ltda.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Anatomical feasibility and applicability of off-the-shelf multi-branched endografts from two device models

研究概览

简要总结

The objective of this retrospective observational study is to evaluate the theoretical anatomical suitability of the new Braile off-the-shelf multi-branched endograft in patients with thoracoabdominal aneurysm. One hundred preoperative contrast-enhanced computed tomography angiographies (CTAs) from patients previously treated with a custom-made endograft will be analyzed. The hypothesis is that a significant proportion of these patients will have anatomical features compatible with the use of the new endograft.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Preoperative CTA images from patients previously treated with Braile's custom-made multi-branched endograft for thoracoabdominal aneurysm.
  • Contrast-enhanced CTAs covering the thorax, abdomen, and pelvis, with thin slices of 1 to 2 mm, available in Braile's imaging database.

排除标准

  • Exams with incomplete or inadequate images, defined as CTAs with slice thickness greater than 2 mm

结局指标

主要结局

Anatomical feasibility and applicability of off-the-shelf multi-branched endografts from two device models

时间窗: completion of the anatomical assessment

Number of patients with anatomical characteristics suitable for the theoretical use of the new Braile off-the-shelf multi-branched endograft.

次要结局

未报告次要终点

研究者

发起方
Braile Biomedica Ind. Com. e Repr. Ltda.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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