NCT02625324

Valiant Evo International Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.

Detailed description

Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 total subjects, in order obtain 87 evaluable subjects for the primary endpoint. The two protocols are identical, and the trials were run simultaneously to enroll subjects concurrently in the United States (US) and Outside United States (OUS). The poolability on the primary endpoint between US and OUS data will be assessed using Fisher's exact test during the data analysis. Data for both trials will be combined and presented as a pooled analysis.

Conditions

• Aortic Aneurysm, Thoracic

Interventions

Type	Name	Description
DEVICE	Valiant Evo Thoracic Stent Graft System	Procedure: thoracic endovascular aneurysm repair (TEVAR)

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-01
• Completion: 2023-03-02
• First posted: 2015-12-09
• Last updated: 2024-04-09
• Results posted: 2019-03-15

Locations

16 sites across 6 countries: Canada, Denmark, France, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study