ANATOMICAL FEASIBILITY OF BRAILE STANDARD BRANCHED ENDOGRAFT

NCT07118995 | Active Not Recruiting

• 1 other identifier: BMETA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

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.

  completion of the anatomical assessment

Study Arms (1)

Patients treated for TAA

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

Other: Analysis of preoperative CTA

Interventions

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

Patients treated for TAA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with thoracoabdominal aortic aneurysm

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Braile Biomedica Ind. Com. e Repr. Ltda.: lead

Study Sites (1)

Hospital Moinho de Ventos

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Vascular Diseases; Aortic Diseases; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aneurysm; Cardiovascular Diseases

Study Officials

• Alexandre A Pereira

  Hospital Moinho de Ventos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)