An interventional study of Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device in Aortic Aneurysm, Aortic Dissection and Penetrating Aortic Ulcer (PAU), sponsored by University of Maryland, Baltimore. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
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.
656 studies on the registry are indexed under Aortic Aneurysm; 113 are open to participants now.
This study's planned enrollment of 100 is above the median of 64 across 313 interventional studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →University of Maryland, Baltimore is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 63 (69%) have results posted.
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Exclusion Criteria:
Patients undergoing aortic replacement using the novel modified SA-FET technique.
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.
All-cause mortality
Rate of death from any cause
Time frame: 30 days
Stroke, excluding transient ischemic attack (TIA)
Rate of stroke
Time frame: 30 days
Early Paralysis, excluding paraparesis
Rate of paralysis
Time frame: 30 days
Technical success
Composite of successful delivery of the device through the vasculature, successful deployment of the device at the intended location, and patient survival
Time frame: 24 hours
Patency of all graft and endograft components
Graft and endograft patency confirmed by computed tomography (CT) imaging assessment
Time frame: At hospital discharge or at 1 month
Complete sealing of the aortic pathology
Absence of Type Ia and IIIa/b endoleak, complete coverage of penetrating aortic ulcer (PAU) cases, and isolation of the primary entry tear in dissection cases, confirmed by CT imaging assessment
Time frame: At hospital discharge or at 1 month
Aortic-related death
Rate of aortic-related death
Time frame: Up to 36 months after the index procedure
Pseudoaneurysm at the treatment sites
Rate of pseudoaneurysm at the treatment sites
Time frame: Up to 36 months after the index procedure
Unanticipated aortic or branch-related reoperation
Rate of unanticipated aortic or branch-related reoperation
Time frame: Up to 36 months after the index procedure
Late endoleak
Rate of Type I or III endoleak confirmed by computed tomography (CT) imaging assessment
Time frame: Up to 36 months after the index procedure
Non-cardiac/non-aortic reoperations
Rate of non-cardiac/non-aortic reoperations
Time frame: Up to 36 months after the index procedure
Vocal cord paralysis
Rate of vocal cord paralysis
Time frame: Up to 36 months after the index procedure
Myocardial infarction
Rate of myocardial infarction
Time frame: Up to 36 months after the index procedure
Respiratory failure
Rate of respiratory failure
Time frame: Up to 36 months after the index procedure
Renal failure requiring dialysis
Rate of renal failure requiring dialysis
Time frame: Up to 36 months after the index procedure
Thromboembolic events
Rate of thromboembolic events
Time frame: Up to 36 months after the index procedure
Loss of patency of a graft or endovascular stent graft, including branch grafts
Rate of loss of patency of a graft or endovascular stent graft, including branch grafts
Time frame: Up to 36 months after the index procedure
Secondary unplanned interventions in the treated vascular segment or related to the original pathology
Rate of secondary unplanned interventions in the treated vascular segment or related to the original pathology
Time frame: Up to 36 months after the index procedure
Aortic rupture
Rate of aortic rupture
Time frame: Up to 36 months after the index procedure
Device integrity failures
Rate of device integrity failures confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Device crimping/kinking
Rate of device crimping/kinking confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Device migration
Rate of device migration (\>10 mm relative to the implantation position), compared with baseline and confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Thrombosis of the device lumen
Rate of thrombosis of the device lumen confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Surgical graft or stent graft infection
Rate of surgical graft or stent graft infection
Time frame: Up to 36 months after the index procedure
Incidence of all endoleak types
Rate of all endoleak types confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Migration of the distal extension
Rate of distal extension migration (\>10 mm based on the position of the device implantation) confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Failure of device-extension integrity resulting in a compromised seal and blood leakage or movement of the device
Rate of extension device integrity issues confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Incidence of Type III endoleak related to the extension device
Rate of Type III endoleak related to the extension device confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Incidence of failed patency of the device-extension overlap
Rate of failed patency of the device-extension overlap confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Incidence of major adverse events (MAE) at 30 days post-extension
Individual rate and type of major adverse events (MAE) at 30 days post-extension
Time frame: Up to 1 month post-extension
Incidence of secondary procedures related to the extension
Rate of secondary procedures related to the extension
Time frame: Up to 36 months after the index procedure
Disabling and/or non-disabling stroke
Rate of occurrence of disabling and/or non-disabling stroke
Time frame: Up to 36 months after the index procedure
Overall incidence of Paralysis and/or paraparesis
Rate of paralysis and/or paraparesis
Time frame: Up to 36 months after the index procedure
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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