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NOT YET RECRUITING
NCT07885865
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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