Clinical trial Recruiting at 2 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorBraile Biomedica Ind. Com. e Repr. Ltda.
Industry-sponsored
Locations3 sites (Vila Velha, Espírito Santo and 2 other locations)
StatusRecruiting
StartedOctober 24, 2023
Main results expectedJuly 30, 2025
Study endsFebruary 28, 2029
Registry record updatedAugust 22, 2024
Trial IDNCT06270537 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

  • 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.

  • 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.

    Recruiting at 3 sites W.L.Gore & Associates · Los Angeles, California and 2 other locations · NCT07564375

  • Using presepsin levels to guide antibiotic treatment in thoracic aorta surgery patients

    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.

    Recruiting Petrovsky National Research Centre of Surgery · Moscow, Moscow · NCT06336213

  • Endovascular treatment for aortic arch pathologies in Spain

    This study is testing if special stent devices can help people aged 18 to 90 with serious aortic arch problems live longer and stay safe.

    Recruiting Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery · Madrid · NCT05309707

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.