A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement
Key facts
- Where
- Baltimore, United StatesSee the site
Where in United States
- University of Maryland Medical CenterBaltimore, United StatesContact: Kaitlyn Masih, BSNNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Maryland, Baltimore
- Trial code
- NCT07885865
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
Supra-Aortic Branch Vessel Stenting With a Hybrid Frozen Elephant Trunk Device: A Novel Wire-Reinforced Fenestration Technique
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.
Inclusion: Age 18 years or older; Willing and able to give written informed consent, or the patient's legally authorized representative has given written informed consent; Expected life expectancy of more than two years after repair; Aortic pathology requiring repair or replacement of multiple damaged or diseased segments of the thoracic aorta, with at least one of the following: (a) thoracic aortic aneurysm at increased risk for rupture or complications; (b) acute aortic dissection requiring urgent repair; (c) aortic pseudoaneurysm at risk for rupture or complications; (d) penetrating aortic ulcer (PAU) at risk for rupture or complications; (e) congenital aortic disease requiring repair.
Exclusion: Unfit for open surgical repair involving circulatory arrest; Currently participating in an investigational drug or another device study within 6 months before the date of implant, or has not reached the primary endpoint of that study; Eligible for treatment with a U.S. Food and Drug Administration (FDA)-approved marketed device; Active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure; Uncorrectable bleeding anomaly; Other medical, social, or psychological conditions that, in the opinion of the investigator, preclude appropriate consent or adherence to the follow-up examinations required by the protocol; Comatose or suffering from irreversible severe brain malperfusion; Known sensitivity to components of the devices; Willing and eligible for enrollment in a manufacturer-sponsored clinical study at any institution; Willing and eligible to participate in a study with a manufacturer-made device at any institution; Pregnant.