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A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement
Sponsor: University of Maryland, Baltimore
Summary
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.
Official title: Supra-Aortic Branch Vessel Stenting With a Hybrid Frozen Elephant Trunk Device: A Novel Wire-Reinforced Fenestration Technique
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-11-01
Completion Date
2032-12-31
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device
The proposed SA-FET procedure consists of a hybrid frozen elephant trunk (FET) device (Thoraflex, Terumo) with up to three reinforced fenestrations on the proximal endograft segment. Each fenestration is sized from 4 to 13 millimeters (mm) based on the size of the targeted supra-aortic vessel and wire-reinforced circumferentially using continuous watertight anastomosis-type suturing with polyester suture, as is done in commercially available fenestrated aortic endografts. The reinforcement provides an anchoring point against the radial force of the branch stents to maintain a seal and prevent tearing of the aortic endograft, and also provides a radiopaque marker. The fenestration is then pre-wired to allow delivery of a branch stent graft (Gore Viabahn). After deployment of the fenestrated graft, the supra-aortic branch stent grafts are deployed. The branch stent may be additionally secured to the fenestration using interrupted or continuous suturing with polypropylene suture.
Locations (1)
University of Maryland Medical Center
Baltimore, Maryland, United States