Supra-Aortic Branch Vessel Stenting With a Hybrid Frozen Elephant Trunk Device: A Novel Wire-Reinforced Fenestration Technique
| Registry | NCT07885865, acronym SA-FET |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | University of Maryland, Baltimore (Other) |
| Conditions | Aortic Aneurysm, Aortic Dissection, Penetrating Aortic Ulcer (PAU), Aortic Pseudoaneurysm, Aortic Arch Replacement |
| Interventions | Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device (Device) |
| Dates | start 2026-11-01 (estimated), primary completion 2032-12-31 (estimated), completion 2032-12-31 (estimated), first posted 2026-10-21, last updated 2026-10-21 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Aortic Aneurysm All trials for Aortic Dissection All trials of Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device
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.
Surgical repair of the aortic arch has evolved significantly over the past several decades in response to persistent challenges related to cerebral protection, operative time, and the complex anatomy of the thoracic aorta. The classic elephant trunk technique allowed for a two-stage repair of extensive aortic disease by leaving a free-floating Dacron graft in the descending thoracic aorta to be addressed during a subsequent operation. While foundational, this staged approach was associated with inter-stage mortality and incomplete aortic remodeling.
In response, the frozen elephant trunk (FET) technique was developed to allow simultaneous treatment of the arch and descending thoracic aorta in a single-stage procedure. By combining an open surgical Dacron graft proximally with a distal stented endograft component (deployed antegrade into the descending aorta), FET became a transformative hybrid approach. However, FET techniques remain technically demanding, particularly when managing supra-aortic branch reimplantation, maintaining cerebral perfusion, and reducing circulatory arrest time. To address these issues, newer procedural refinements have emerged, including the Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER) technique.
The B-SAFER technique entails deploying the endograft with a proximal landing zone in zone 1 or 2 of the aortic arch, in situ fenestration of the graft and insertion of branch stent grafts in one or more of the supra-aortic branch vessels via the fenestration. A surgical Dacron graft is then sewn to incorporate the distal aorta and the aortic endograft. This technique has had promising early results and is currently under investigation with an ongoing physician-sponsored investigational device exemption study at the Cleveland Clinic.
Subsequently, hybrid FET devices such as the Thoraflex Hybrid (Terumo Aortic) and E-vita Open Plus (Jotec) have become widely used internationally. These devices incorporate a surgical aortic graft and an endograft together to obviate the need for surgeons to sew the two together, such as in the B-SAFER technique. This can lead to a significant reduction in circulatory arrest time. However, the stenting of supra-aortic vessels with hybrid FET devices has not been routinely performed, or systematically evaluated, as direct access to the endograft proves more challenging than with the B-SAFER technique, where a separate endograft and surgical aortic graft are used. The investigators introduce a novel modification of a hybrid FET device that enables supra-aortic vessel stenting. This technique involves a wire-reinforced fenestration made on the endograft portion of the hybrid FET device that is pre-wired. A branch stent graft is then delivered through this fenestration and allows for supra-aortic vessel stenting. One of the key advantages of this modification is the improvement in seal between the branch stents and the endograft. The wire-reinforcement prevents tearing of the endograft which can lead to early endoleak, as seen in 7% or more of B-SAFER patients. In addition, this technique can allow for direct suture fixation of the branch stent to the wire-reinforced fenestration preventing migration of the components and further improving seal.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Supra-aortic frozen elephant trunk (SA-FET) | Experimental | Device: Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device | Patients undergoing aortic replacement using the novel modified SA-FET technique. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Age 18 years or older. 2. Willing and able to give written informed consent, or the patient's legally authorized representative has given written informed consent. 3. Expected life expectancy of more than two years after repair. 4. 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 Criteria: 1. Unfit for open surgical repair involving circulatory arrest. 2. Comatose or suffering from irreversible severe brain malperfusion. 3. Known sensitivity to components of the devices. 4. Active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure. 5. 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. 6. Eligible for treatment with a U.S. Food and Drug Administration (FDA)-approved marketed device. 7. Willing and eligible for enrollment in a manufacturer-sponsored clinical study at any institution. 8. Willing and eligible to participate in a study with a manufacturer-made device at any institution. 9. Uncorrectable bleeding anomaly. 10. Pregnant. 11. 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.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Maryland Medical Center | Baltimore, Maryland | United States |