Multicenter Study to Collect Real-World Data on the Dominus4 Stent-Graft for Treating Thoracic Aortic Diseases

What this Trial Is About

This research aims to collect real-world clinical data on the Dominus4 Stent-Graft used for treating thoracic aortic diseases, such as thoracic aortic dissection. The study focuses on evaluating the safety and effectiveness of this endovascular device following its approved Instructions for Use. It is a multicenter, observational study involving patients who have undergone this treatment. Participants will receive the Dominus4 Stent-Graft device as part of their endovascular repair procedure for thoracic aortic diseases. The study will observe patients prospectively after their procedure, following them at scheduled intervals to gather information. There is no randomization or placebo group since this is a post-market observational study. During the study, participants will be monitored for early adverse events within one month after the procedure, which is the primary safety outcome. Additional assessments include device success during surgery, absence of device fracture, endoleaks, reintervention rates, and adverse events tracked up to five years. Participants need to be available for follow-up visits over the study period, which lasts several years, to collect comprehensive safety and efficacy data.

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