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Recruiting NCT06270537
Post-market Clinical Trial of the Dominus® Stent-Graft
Trial Parameters
Condition Thoracic Aortic Dissection
Sponsor Braile Biomedica Ind. Com. e Repr. Ltda.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-10-24
Completion 2025-07-30
Interventions
Stent-Graft Dominus® Endoprosthesis
Brief Summary
Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use
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.