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NCT Number: NCT07118995

ANATOMICAL FEASIBILITY OF BRAILE STANDARD BRANCHED ENDOGRAFT

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Thoracoabdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Diseases Cardiovascular Diseases Endovascular Repair of Aortic Aneurysm Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Moinho de Ventos

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Analysis of preoperative CTA

Other

A review of preoperative contrast-enhanced CTA from patients with thoracoabdominal aneurysms, included in Braile's database, who were indicated for endovascular treatment with Braile's custom-made multi-branched endograft between 2022 and 2024

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Braile Biomedica Ind. Com. e Repr. Ltda.

Industry

Registry information

Official study title

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

Acronym: BMETA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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