Post-market Clinical Trial of the Dominus® Stent-Graft

Launched by BRAILE BIOMEDICA IND. COM. E REPR. LTDA. · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the Dominus® Stent-Graft, a medical device used to treat thoracic aortic dissection, which is a serious condition affecting the large blood vessel that carries blood from the heart. The goal is to gather real-world evidence about how safe and effective this stent-graft is in treating this condition when used according to the manufacturer's instructions.

To participate in the trial, you need to be at least 18 years old and have received the Dominus® Stent-Graft as part of your treatment. It’s important that you can attend follow-up appointments for the study duration and that you understand the study and agree to take part by signing a consent form. If you're currently involved in another clinical study or have a life expectancy of less than 12 months, you won't be eligible. Participants can expect regular check-ins during the study to monitor their health and the performance of the stent-graft.

Gender

ALL

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.