Evaluating the Dominus® Stent-Graft for treating thoracic aortic diseases
Official title: Multicenter Study Collecting Post-market Clinical Data on the Dominus® Stent-Graft for Treating Thoracic Aortic Diseases
Run by Braile Biomedica Ind. Com. e Repr. Ltda. · NCT06270537 · Data updated 2026-11-12
This study is testing how well the Dominus® Stent-Graft works for people with thoracic aortic diseases by collecting real-world data on its safety and effectiveness.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Braile Biomedica Ind. Com. e Repr. Ltda. Industry-sponsored |
| Locations | 3 sites (Vila Velha, Espírito Santo and 2 other locations) |
| Status | Recruiting |
| Started | October 24, 2023 |
| Main results expected | July 30, 2025 |
| Study ends | February 28, 2029 |
| Registry record updated | August 22, 2024 |
| Trial ID | NCT06270537 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are treated with the Dominus® Stent-Graft according to its guidelines.
✕Probably not a fit
Patients with a life expectancy of less than 12 months or those participating in other clinical studies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects real-world clinical data on the safety and efficacy of the Dominus® Stent-Graft Endoprosthesis in patients with thoracic aortic diseases. It involves a multicenter approach, enrolling 100 patients who will receive the stent-graft according to its Instructions for Use. The study aims to provide insights into the performance of the device in a post-market setting, with a focus on long-term follow-up and patient outcomes.
Why it matters
Potential benefit: If successful, this study could enhance treatment options and improve outcomes for patients with thoracic aortic dissection.
How similar studies have gone: While this study builds on existing knowledge of stent-grafts, it specifically evaluates a post-market device, making it a novel contribution to the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years of age or older; 2. Patients treated with the Dominus® Stent-Graft Endoprosthesis in accordance with its Instructions for Use; 3. Patient available for appropriate follow-up times for the study duration; 4. Informed patient about the nature of the study, agreeing to its provisions, and signing the informed consent. Exclusion Criteria: 1. Patient currently participating in another clinical study of drug or medical device; 2. Life expectancy less than 12 months.
Where it's running
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Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil Recruiting -
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil Recruiting -
Hospital Evangélico de Vila Velha
Vila Velha, Espírito Santo, Brazil Not yet recruiting
Study contacts
- Principal investigator: Edwaldo Joviliano — Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
- Study coordinator: Glaucia Basso
- Email: glaucia.basso@braile.com.br
- Phone: +55 (17) 2136-7005
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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GORE MBA Arch Endoprosthesis Early Feasibility Study
This study tests the safety of the MBA device in people with arch-related thoracic aortic diseases to see if it can be used safely in real-world settings.
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This study is testing if measuring a specific marker in the blood can help doctors give the right antibiotics to patients after thoracic aorta surgery to prevent infections and improve recovery.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.