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Active, not recruitingNCT07118995BMETAUpdated Aug 12, 2025

ANATOMICAL FEASIBILITY OF BRAILE STANDARD BRANCHED ENDOGRAFT

An observational study in Thoracoabdominal Aortic Aneurysm, Endovascular Repair of Aortic Aneurysm and Vascular Diseases, sponsored by Braile Biomedica Ind. Com. e Repr. Ltda.. Active, not recruiting at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2025-08-12.

Sponsored by Braile Biomedica Ind. Com. e Repr. Ltda. · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Thoracoabdominal aortic aneurysm
  • Off-the-shelf endograft
  • Anatomical feasibility
03

In context

Aortic Aneurysm, Thoracoabdominal

63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 20 observational studies indexed under Aortic Aneurysm, Thoracoabdominal.

Browse Aortic Aneurysm, Thoracoabdominal studies →

Lead sponsor

Braile Biomedica Ind. Com. e Repr. Ltda. is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with thoracoabdominal aortic aneurysm

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Exams with incomplete or inadequate images, defined as CTAs with slice thickness greater than 2 mm
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients treated for TAA

    Patients with thoracoabdominal aortic aneurysms treated with a custom-designed multi-branched endograft.

    Other: Analysis of preoperative CTA

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: completion of the anatomical assessment

07

Study locations

1 site
  • Hospital Moinho de Ventos
    Porto Alegre, Rio Grande do Sul, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2025 (actual). Primary completion is estimated for Oct 2025, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2025
First posted
Aug 12, 2025
StartActual
Aug 1, 2025
Primary completionEst.
Oct 2025
CompletionEst.
Oct 2025
Last update
Aug 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07118995
Lead sponsor
Braile Biomedica Ind. Com. e Repr. Ltda.
Responsible party
Sponsor
First posted
Aug 12, 2025
Start date
Aug 1, 2025
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Aug 12, 2025

Study contacts

Alexandre A Pereira
principal investigator · Hospital Moinho de Ventos

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies from this sponsor

Braile Biomedica Ind. Com. e Repr. Ltda.

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