Modified SA-FET Device for Aortic Arch Conditions
(SA-FET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this prospective, non-randomized trial is to determine the safety and technical success of a novel modification to a U.S. Food and Drug Administration (FDA)-approved hybrid frozen elephant trunk (FET) device (Thoraflex Hybrid, Terumo Aortic). The modification is intended to enable supra-aortic vessel stenting in patients undergoing aortic arch replacement for aortic aneurysm or dissection.
Are You a Good Fit for This Trial?
This trial is for people who need surgery to replace part of their aorta due to conditions like aortic aneurysm, dissection, or ulcers. Participants must be eligible for aortic arch replacement and require treatment involving the supra-aortic vessels.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device
Trial Overview
The study tests a new version of an existing surgical device (the SA-FET) designed to make it easier and safer to place stents in blood vessels branching from the aorta during major heart surgery. The trial looks at how safe and effective this modified device is.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergoing aortic replacement using the novel modified SA-FET technique.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
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