Evaluation of Valiant Mona LSA
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|ClinicalTrials.gov Identifier: NCT02365467|
Recruitment Status : Active, not recruiting
First Posted : February 19, 2015
Results First Posted : October 21, 2022
Last Update Posted : October 21, 2022
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.
|Condition or disease||Intervention/treatment|
|Aortic Aneurysm, Thoracic, Chronic Type B Dissection||Device: Valiant Mona LSA Thoracic Stent Graft System|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending Thoracic Aortic Aneurysms and Chronic Dissections|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||September 19, 2019|
|Estimated Study Completion Date :||October 2024|
|Experimental: Treatment with Valiant Mona LSA device||
Device: Valiant Mona LSA Thoracic Stent Graft System
- 30 Day Composite Safety Endpoint [ Time Frame: 1 month ]
Within 1 month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of:
- Aorta Related Mortality
- Left Arm/Hand Ischemia
- 30 Day Treatment Success [ 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 Main Stent Graft and Branch Stent Graft at 30 day visit. This endpoint is site reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365467
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|