Overview
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
Description
The multicenter study aims to collect post-market clinical data on the Dominus® Stent-Graft in the treatment of thoracic aortic diseases. With the goal of assessing safety and efficacy, the prospective follow-up study will include 100 patients undergoing Endovascular Treatment of Thoracic Aortic Diseases, following the product's Instructions for Use
Eligibility
Inclusion Criteria:
- 18 years of age or older;
- Patients treated with the Dominus® Stent-Graft Endoprosthesis in accordance with its Instructions for Use;
- Patient available for appropriate follow-up times for the study duration;
- Informed patient about the nature of the study, agreeing to its provisions, and signing the informed consent.
Exclusion Criteria:
- Patient currently participating in another clinical study of drug or medical device;
- Life expectancy less than 12 months.