Clinical Trial: Valiant Evo US Clinical Trial

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

Official Title: Valiant Evo US Clinical Trial

Brief 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.

Detailed Summary:
Sponsor: Medtronic Endovascular

Current Primary Outcome:

• Access and/or deployment failures [ Time Frame: 30 Days ]
  Composite safety and effectiveness endpoint that is based on the proportion of subjects who experienced access and/or deployment failures
• Major device effect (MDE) [ Time Frame: 30 Days ]
  Composite safety and effectiveness endpoint that is based on the proportion of subjects who experienced Major Device Effect

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Peri-Operative Mortality [ Time Frame: 30 Days ]
  Mortality within 30 days
• All Adverse Events [ Time Frame: 30 Days ]
  AEs within 30 days
• All Adverse Events [ Time Frame: 183 Days ]
  AEs within 183 days
• All Adverse Events [ Time Frame: 365 Days ]
  AEs within 365 days
• Secondary procedures [ Time Frame: 30 days ]
  Secondary procedures within 30 days
• Secondary procedures [ Time Frame: 183 days ]
  Secondary procedures within 183 days
• Secondary procedures [ Time Frame: 365 days ]
  Secondary procedures within 365 days
• Loss of Stent Graft Patency [ Time Frame: 30 days ]
  Loss of stent graft patency within 30 days
• Loss of Stent Graft Patency [ Time Frame: 6 months ]
  Loss of stent graft patency within 6 months
• Loss of Stent Graft Patency [ Time Frame: 12 months ]
  Loss of stent graft patency within 12 months
• Endoleaks [ Time Frame: 30 days ]
  Endoleaks within 30 days
• Endoleaks [ Time Frame: 6 months ]
  Endoleaks within 6 months
• Endoleaks [ Time Frame: 12 months ]
  Endoleaks within 12 months
• Aneurysm expansion > 5 mm relative to 1 month visit [ Time Frame: 6 months ]
  Aneurysm expansion between 1 month and 6 months
• Aneurysm expansion > 5 mm relative to 1 month visit [ Time Frame: 12 months ]
  Aneurysm expansion between 1 month and 12 months
• All cause mortality [ Time Frame: 183 days ]
  All cause mortality within 183 days
• All cause mortality [ Time Frame: 365 days ]
  All cause mortality within 365 days
• Aneurysm-related mortality [ Time Frame: 183 days ]
  Aneurysm related mortality within 183 days
• Aneurysm-related mortality [ Time Frame: 365 days ]
  Aneurysm related mortality within 365 days
• Major Device Effects [ Time Frame: 183 days ]
  MDEs within 183 days
• Major Device Effects [ Time Frame: 365 days ]
  MDEs within 365 days

Original Secondary Outcome:

• Peri-Operative Mortality [ Time Frame: 30 Days ]
• All Adverse Events [ Time Frame: 30 Days ]
• All Adverse Events [ Time Frame: 183 Days ]
• All Adverse Events [ Time Frame: 365 Days ]
• Secondary procedures [ Time Frame: 30 days ]
• Secondary procedures [ Time Frame: 183 days ]
• Secondary procedures [ Time Frame: 365 days ]
• Loss of Stent Graft Patency [ Time Frame: 30 days ]
• Loss of Stent Graft Patency [ Time Frame: 6 months ]
• Loss of Stent Graft Patency [ Time Frame: 12 months ]
• Endoleaks [ Time Frame: 30 days ]
• Endoleaks [ Time Frame: 6 months ]
• Endoleaks [ Time Frame: 12 months ]
• Aneurysm expansion > 5 mm relative to 1 month visit [ Time Frame: 6 months ]
• Aneurysm expansion > 5 mm relative to 1 month visit [ Time Frame: 12 months ]
• All cause mortality [ Time Frame: 183 days ]
• All cause mortality [ Time Frame: 365 days ]
• Aneurysm-related mortality [ Time Frame: 183 days ]
• Aneurysm-related mortality [ Time Frame: 365 days ]
• Major Device Effects [ Time Frame: 183 days ]
• Major Device Effects [ Time Frame: 365 days ]

Information By: Medtronic Endovascular

Dates:
Date Received: January 8, 2016
Date Started: March 2016
Date Completion: April 2018
Last Updated: May 2, 2017
Last Verified: January 2017