NCT03246126|CompletedResultsFDA Device
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Sponsor study identifier
interventional
17
1 country
1
Study Start
November 1, 2017
Actual (reported)Primary Completion
June 7, 2023
Actual (reported)Study Completion
June 7, 2023
Actual (reported)The purpose of this study is to evaluate the use of an investigational device called the ValiantTM Visceral Manifold Thoracoabdominal Stent Graft System for the repair of thoracoabdominal aortic aneurysms (TAAA), which is a balloon-like bulge in the aorta (major artery leading away from your heart) that originates in your chest and extends to your abdomen and also includes the branch arteries that supply blood to the liver, spleen, intestine, kidneys and other organs in your abdomen. The word "investigational" means the device is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 7, 2023
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.
August 2, 2017
Actual (reported)August 11, 2017
Actual (reported)November 1, 2017
Actual (reported)June 7, 2023
Actual (reported)June 7, 2023
Actual (reported)April 10, 2024
Actual (reported)Freedom From Major Adverse Events (MAE) at Day 30
Freedom from MAE is defined as the number of participants who have not experienced a major adverse event (including death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke) at 30 days.
Up to Day 30
Number of Participants Who Achieve Technical Success
Technical success is defined as successful access of the aneurysm site and deployment of the Visceral Manifold investigational devices in intended locations.
Up to Year 1
Freedom From Paraplegia at Day 30
Up to Day 30
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
New York University School of Medicine
New York, New York, 10016, United States
Thomas Maldonado
NYU Langone Health
17 participants (actual enrollment reported by the registry).
First Submitted
August 2, 2017
First Posted
August 11, 2017
Study Start
November 1, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 7, 2023
Actual (reported)Study Completion
June 7, 2023
Actual (reported)Last Updated
April 10, 2024
Results First Posted
April 10, 2024
Record last verified: 2024-03
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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