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ANATOMICAL FEASIBILITY OF BRAILE STANDARD BRANCHED ENDOGRAFT

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07118995
Acronym
BMETA
Enrollment
100
Registered
2025-08-12
Start date
2025-08-01
Completion date
2025-10-31
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Thoracoabdominal aortic aneurysm, Off-the-shelf endograft, Anatomical feasibility

Brief summary

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.

Interventions

OTHERAnalysis of preoperative CTA

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

Sponsors

Braile Biomedica Ind. Com. e Repr. Ltda.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anatomical feasibility and applicability of off-the-shelf multi-branched endografts from two device modelscompletion of the anatomical assessmentNumber of patients with anatomical characteristics suitable for the theoretical use of the new Braile off-the-shelf multi-branched endograft.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026