Evaluating the Dominus® Stent-Graft for treating thoracic aortic diseases

Multicenter Study Collecting Post-market Clinical Data on the Dominus® Stent-Graft for Treating Thoracic Aortic Diseases

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
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda. (Industry-sponsored)
• Locations: 3 sites (Vila Velha, Espírito Santo and 2 other locations)
• Trial ID: NCT06270537 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are treated with the Dominus® Stent-Graft according to its guidelines.

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.

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 performed: 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.

Eligibility 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 this trial is running

Vila Velha, Espírito Santo and 2 other locations

• Hospital Evangélico de Vila Velha — Vila Velha, Espírito Santo, Brazil (Not_yet_recruiting)
• 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)

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

Conditions Thoracic Aortic Dissection; Aneurysm; Acute Aortic Syndrome; Aortic Dissection; Aortic Diseases; Cardiovascular Diseases