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Valiant Evo US Clinical Trial — VEVO  

Aortic Aneurysm, Thoracic Clinical Trial

Official title:
Valiant Evo US Clinical Trial

Clinical Trial Summary

The purpose of the Valiant Evo US 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.

Clinical Trial 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 to 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02652949
Study type Interventional
Source Medtronic Cardiovascular
Contact
Status Completed
Phase N/A
Start date April 2016
Completion date March 2, 2023
View Details
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