Thoracoabdominal Aortic AneurysmBMETANCT07118995
ANATOMICAL FEASIBILITY OF BRAILE STANDARD BRANCHED ENDOGRAFT
An observational study of Thoracoabdominal Aortic Aneurysm and Endovascular Repair of Aortic Aneurysm, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm, Endovascular Repair of Aortic Aneurysm, Vascular Diseases
- What is being tested?
- Analysis of preoperative CTA
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2025to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with thoracoabdominal aortic aneurysm
Who may be able to join
- 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.
Who cannot join
- Exams with incomplete or inadequate images, defined as CTAs with slice thickness greater than 2 mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anatomical Feasibility of the Braile Off-the-Shelf Multi-Branched Endograft for the Treatment of Thoracoabdominal Aneurysm
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
- Being tested
- Analysis of preoperative CTA
- Keywords
- Thoracoabdominal aortic aneurysm, Off-the-shelf endograft, Anatomical feasibility
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal, Vascular Diseases, Aortic Diseases, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of preoperative CTAOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for TAA | Patients with thoracoabdominal aortic aneurysms treated with a custom-designed multi-branched endograft. Receives: Other: Analysis of preoperative CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: completion of the anatomical assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Aug 2025
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre A Pereira, Principal investigator, Hospital Moinho de Ventos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118995
- Sponsor's protocol ID
- BMETA
- Acronym
- BMETA
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Feasibility of the Braile Off-the-Shelf Multi-Branched Endograft for the Treatment of Thoracoabdominal Aneurysm
- ClinicalTrials.gov ID
- NCT07118995
- Acronym / sponsor ID
- BMETA / BMETA
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for TAA | – | Other: Analysis of preoperative CTAPatients with thoracoabdominal aortic aneurysms treated with a custom-designed multi-branched endograft. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with thoracoabdominal aortic aneurysm
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Exams with incomplete or inadequate images, defined as CTAs with slice thickness greater than 2 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of preoperative CTAA 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 | Other | Patients treated for TAA |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre A Pereira principal investigator
Hospital Moinho de Ventos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracoabdominal Aortic Aneurysm and Endovascular Repair of Aortic Aneurysm, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical feasibility and applicability of off-the-shelf multi-branched endografts from two device models (time frame: completion of the anatomical assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.