Clinical Trial: Valiant Evo International Clinical Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Valiant Evo International Clinical Trial

Brief 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. The Valiant Evo International Clinical Trial is a first-in human experience with the objective to provide clinical data for supporting CE marking via case series and descriptive statistics.

Detailed Summary:
Sponsor: Medtronic Endovascular

Current Primary Outcome: Composite safety and effectiveness endpoint that is based on the proportion of subjects who experienced: (a) Access and/or deployment failures; and/or (b) MDE [ Time Frame: within 30 days post index procedure ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medtronic Endovascular

Dates:
Date Received: December 2, 2015
Date Started: May 2016
Date Completion: September 2018
Last Updated: February 1, 2017
Last Verified: January 2017