Clinical Trial: Evaluation of Valiant Mona LSA

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending Thoracic Aortic Aneurysms and Chronic Dissections

Brief Summary:

The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the identified subject population. This study will also evaluate the current instructions for use and may direct changes to the delivery and deployment steps.

The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona LSA Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B dissections.


Detailed Summary:
Sponsor: Medtronic Endovascular

Current Primary Outcome:

  • Primary Safety Observation, composite endpoint consisting of: •Aorta Related Mortality •Stroke •Paraplegia •Left Arm/Hand Ischemia [ Time Frame: 1 month ]

    Within 1 month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of:

    • Aorta Related Mortality
    • Stroke
    • Paraplegia
    • Left Arm/Hand Ischemia
  • Primary Effectiveness Observation defined as as technical success and successful exclusion of the aneurysm or false lumen [ Time Frame: 1 month ]
    Treatment success which is defined as technical success (the successful delivery and deployment of the Valiant Mona LSA Thoracic Stent Graft System in the planned location with no unintentional coverage of other vessels, assessed intra-operatively, and the removal of the delivery system) and successful exclusion of the aneurysm or false lumen while maintaining patency of the MSG and BSG at 30 day visit.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medtronic Endovascular

Dates:
Date Received: February 11, 2015
Date Started: April 2015
Date Completion: February 2022
Last Updated: January 31, 2017
Last Verified: February 2017