Post-market Clinical Trial of the Dominus® Stent-Graft
Recruiting
- Conditions
- Thoracic Aortic Dissection
- Registration Number
- NCT06270537
- Lead Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Inclusion Criteria:<br><br> 1. 18 years of age or older;<br><br> 2. Patients treated with the Dominus® Stent-Graft Endoprosthesis in accordance with its<br> Instructions for Use;<br><br> 3. Patient available for appropriate follow-up times for the study duration;<br><br> 4. Informed patient about the nature of the study, agreeing to its provisions, and<br> signing the informed consent.<br><br>Exclusion Criteria:<br><br> 1. Patient currently participating in another clinical study of drug or medical device;<br><br> 2. Life expectancy less than 12 months.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early occurrence of adverse events (Safety Outcome)
- Secondary Outcome Measures
Name Time Method Device Success;Absence of endoprosthesis fracture;Endoleak;Reintervention-free;Adverse Events