Aortic AneurysmSA-FETNCT07885865
A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement
A study testing Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device in people with Aortic Aneurysm and Aortic Dissection, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Aortic Dissection, Penetrating Aortic Ulcer (PAU)
- What is being tested?
- Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Dec 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unfit for open surgical repair involving circulatory arrest.
- Comatose or suffering from irreversible severe brain malperfusion.
- Known sensitivity to components of the devices.
- Active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure.
- 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.
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- 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.
- Uncorrectable bleeding anomaly.
- Pregnant.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
Kaitlyn Masih, BSN, 410-328-4562, kmasih@som.umaryland.edu
Aakash Shah, MD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Aortic Aneurysm, Aortic Dissection, Penetrating Aortic Ulcer (PAU), Aortic Pseudoaneurysm, Aortic Arch Replacement
- Being tested
- Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection, Penetrating Atherosclerotic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Supra-aortic frozen elephant trunk (SA-FET) | Experimental | Patients undergoing aortic replacement using the novel modified SA-FET technique. Receives: Device: Modified Supra-Aortic Frozen Elephant Trunk (SA-FET) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Rate of death from any cause
Measured: 30 days
Stroke, excluding transient ischemic attack (TIA)
Rate of stroke
Measured: 30 days
Early Paralysis, excluding paraparesis
Rate of paralysis
Measured: 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
Measured: 24 hours
Patency of all graft and endograft components
Graft and endograft patency confirmed by computed tomography (CT) imaging assessment
Measured: 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
Measured: At hospital discharge or at 1 month
Secondary outcomes (27)
Aortic-related death
Rate of aortic-related death
Measured: Up to 36 months after the index procedure
Pseudoaneurysm at the treatment sites
Rate of pseudoaneurysm at the treatment sites
Measured: Up to 36 months after the index procedure
Unanticipated aortic or branch-related reoperation
Rate of unanticipated aortic or branch-related reoperation
Measured: Up to 36 months after the index procedure
Late endoleak
Rate of Type I or III endoleak confirmed by computed tomography (CT) imaging assessment
Measured: Up to 36 months after the index procedure
Non-cardiac/non-aortic reoperations
Rate of non-cardiac/non-aortic reoperations
Measured: Up to 36 months after the index procedure
Vocal cord paralysis
Rate of vocal cord paralysis
Measured: Up to 36 months after the index procedure
Myocardial infarction
Rate of myocardial infarction
Measured: Up to 36 months after the index procedure
Respiratory failure
Rate of respiratory failure
Measured: Up to 36 months after the index procedure
Renal failure requiring dialysis
Rate of renal failure requiring dialysis
Measured: Up to 36 months after the index procedure
Thromboembolic events
Rate of thromboembolic events
Measured: 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
Measured: 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
Measured: Up to 36 months after the index procedure
Aortic rupture
Rate of aortic rupture
Measured: Up to 36 months after the index procedure
Device integrity failures
Rate of device integrity failures confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Device crimping/kinking
Rate of device crimping/kinking confirmed by CT imaging assessment
Measured: 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
Measured: 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
Measured: Up to 36 months after the index procedure
Surgical graft or stent graft infection
Rate of surgical graft or stent graft infection
Measured: Up to 36 months after the index procedure
Incidence of all endoleak types
Rate of all endoleak types confirmed by CT imaging assessment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 1 month post-extension
Incidence of secondary procedures related to the extension
Rate of secondary procedures related to the extension
Measured: Up to 36 months after the index procedure
Disabling and/or non-disabling stroke
Rate of occurrence of disabling and/or non-disabling stroke
Measured: Up to 36 months after the index procedure
Overall incidence of Paralysis and/or paraparesis
Rate of paralysis and/or paraparesis
Measured: Up to 36 months after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aakash Shah, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885865
- Sponsor's protocol ID
- HP-00120163
- Acronym
- SA-FET
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Coselli JS, Roselli EE, Preventza O, Malaisrie SC, Stewart A, Stelzer P, Takayama H, Chen EP, Estrera AL, Gleason TG, Fischbein MP, Girardi LN, Patel HJ, Bavaria JE, LeMaire SA. Total aortic arch replacement using a frozen elephant trunk device: Results of a 1-year US multicenter trial. J Thorac Cardiovasc Surg. 2024 May;167(5):1680-1692.e2. doi: 10.1016/j.jtcvs.2022.08.029. Epub 2022 Sep 6.
PubMed 36253292Luo C, Jia B, Li C, Ge Y, Zhong Y, Qiao Z, Wang C, Sun L, Zhu J. Perfusion management of arch-clamping technique in total arch replacement with frozen elephant trunk. Perfusion. 2024 Jan;39(1):182-188. doi: 10.1177/02676591221134221. Epub 2022 Oct 26.
PubMed 36285489Shah A, Leibowitz J, Lu J, Tran D, Stallings J, Toursavadkohi S, Taylor B, Ghoreishi M. Total Arch With Hybrid Frozen Elephant Trunk Versus Branched Stented Anastomosis Frozen Elephant Trunk Repair. Interdiscip Cardiovasc Thorac Surg. 2025 Jul 3;40(7):ivaf164. doi: 10.1093/icvts/ivaf164.
PubMed 40644331Grabenwoger M, Mach M, Machler H, Arnold Z, Pisarik H, Folkmann S, Harrer ML, Geisler D, Moidl R, Winkler B, Bonatti J, Czerny M, Weiss G. Taking the frozen elephant trunk technique to the next level by a stented side branch for a left subclavian artery connection: a feasibility study. Eur J Cardiothorac Surg. 2021 Jun 14;59(6):1247-1254. doi: 10.1093/ejcts/ezaa486.
PubMed 33486518Bhagat R, Roselli EE. Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER): A Versatile Approach to Simplify Arch Vessel Management in Total Arch Replacement. Innovations (Phila). 2025 May-Jun;20(3):246-247. doi: 10.1177/15569845251345822. Epub 2025 Jun 19. No abstract available.
PubMed 40538031Hashizume K, Matsuoka T, Mori M, Takaki H, Koizumi K, Kaneyama H, Funaishi K, Kuroo K, Shimizu H. Total arch replacement with extended branched stented anastomosis frozen elephant trunk repair for type A dissection improves operative outcome. JTCVS Tech. 2022 Nov 3;17:1-9. doi: 10.1016/j.xjtc.2022.10.011. eCollection 2023 Feb.
PubMed 36820356Roselli EE, Vargo PR, Bakaeen F, Koprivanac M, Burns D, Kuramochi Y, Gillinov M; B-SAFER Investigators. Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study. J Thorac Cardiovasc Surg. 2024 Sep;168(3):746-756. doi: 10.1016/j.jtcvs.2023.09.069. Epub 2023 Oct 5.
PubMed 37802330