Anatomical Feasibility of the Braile Off-the-Shelf Multi-Branched Endograft for the Treatment of Thoracoabdominal Aneurysm
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Anatomical feasibility and applicability of off-the-shelf multi-branched endografts from two device models
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported