NCT01839695|CompletedResults
Safety and Efficacy of Valiant Mona LSA Stent Graft System
Valiant Mona LSA Stent Graft System Early Feasibility Study
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Valiant Mona LSA Stent Graft System Early Feasibility Study
Sponsor study identifier
interventional
9
2 countries
3
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)Study Completion
December 2018
Actual (reported)The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to assess safety and performance of the device acutely and at 30 days.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 11, 2013
Actual (reported)April 25, 2013
Actual (reported)February 2014
Actual (reported)October 29, 2014
Actual (reported)December 2018
Actual (reported)Primary Safety Observation - Rate of Major Adverse Events (MAEs)
Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.
1 month
Primary Effectiveness Observation
Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit.
1 month
TEVAR procedure using Medtronic Stent Graft
All subjects will be implanted with this device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28203, United States
Cleveland Clinic
Cleveland, Ohio, 27465, United States
St George's Vascular Institute, St. George's Hospital
London, United Kingdom
Roselli EE, Arko FR 3rd, Thompson MM; Valiant Mona LSA Trial Investigators. Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms. J Vasc Surg. 2015 Dec;62(6):1465-71.e3. doi: 10.1016/j.jvs.2015.07.078. Epub 2015 Oct 23.
Eric Roselli, MD
The Cleveland Clinic
9 participants (actual enrollment reported by the registry).
First Submitted
April 11, 2013
First Posted
April 25, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections
Contact the study team to confirm eligibility.
Primary Completion
February 2014
Actual (reported)Study Completion
December 2018
Actual (reported)Last Updated
July 3, 2023
Results First Posted
October 29, 2014
Record last verified: 2023-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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