NCT06270537

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

Multicenter Study Collecting Post-market Clinical Data on the Dominus® Stent-Graft for Treating Thoracic Aortic Diseases

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Thoracic Aortic Dissection

Interventions

Type	Name	Description
DEVICE	Stent-Graft Dominus® Endoprosthesis	Placement of the Dominus® Stent-Graft for endovascular repair of diseases of the Thoracic Aorta

Timeline

• Start date: 2023-10-24
• Primary completion: 2025-07-30
• Completion: 2029-02-28
• First posted: 2024-02-21
• Last updated: 2024-08-22

Locations

3 sites across 1 country: Brazil