Endovascular Arch Repair Using a Novel Single Branch Arch Stent Graft: 30-Day Results from the Chronic Dissection Arm of the NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness Investigational Device Exemption Study

Authors

• Bradley G. Leshnower, Emory University
• Jean Panneton, Macon & Joan Brock Virginia Health Sciences at Old Dominion UniversityFollow
• Himanshu J. Patel, University of Michigan-Ann Arbor
• Adam W. Beck, University of Alabama
• Mathew Wooster, Lexington Medical Center
• Kyle W. Eudailey, University of Alabama, Birmingham
• Shinichi Fukuhara, University of Michigan - Ann Arbor
• Jae Cho, Case Western Reserve University
• Sanford Zeigler, Medical University of South Carolina
• Westley Ohman, Washington University
• Puja Kachroo, Washington University
• Derek Brinster, Lenox Hill Hospital
• Shahab Toursavadkohi, Washington University
• Mehrdad Ghoreishi, Johns Hopkins Hospital
• Brandley Taylor, Baptist Health Heart and Vascular Care, Boca Raton, Fla
• Frank Arko, Sanger Heart & Vascular Care, Boca Raton, Fla
• Paul Hayes, St. John's Innovation Centre, Cambridge
• Ross Milner, University of Chicago

Document Type

Article

Publication Date

2026

DOI

10.1016/j.xjse.2026.100113

Publication Title

JTCVS Structural and Endovascular

Volume

10

Pages

100113

Abstract

Objective

Moderate levels of frailty or a previous sternotomy make open repair of aortic arch pathology high risk or even preclude any treatment. This study examined 30-day outcomes from the NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness investigational device exemption (TRIOMPHE IDE) study of an off-the-shelf stent-graft system for Zone 0 endovascular aortic arch repair in patients with high-risk chronic dissection.

Methods

TRIOMPHE IDE is a prospective, multicenter study evaluating the NEXUS system (Endospan) in chronic aortic dissection (n = 54). Following cervical debranching, NEXUS was delivered into the arch first, followed by an ascending aortic stent-graft.

Results

All subjects were deemed high-risk for open repair (American Society of Anesthesiologists class IV 51.9% or class III 48.1%; mean European System for Cardiac Operative Risk Evaluation II score 10.3%). Comorbidities included chronic obstructive pulmonary disease (18.5%), coronary disease (42.6%), previous stroke (25.9%), and 70% with previous sternotomy. Successful deployment occurred in 100% of cases, with device technical success in 98.2% (53 out of 54) as 1 retrograde type A dissection required open repair. Thirty-day mortality was 9.3% (5 out of 54). One disabling stroke occurred after bypass (1.9%). There was 1 disabling thromboembolic stroke and 1 intracranial hemorrhage (3.7%) after the index procedure. There were no aortic ruptures, spinal cord ischemia, or permanent dialysis. On core-lab adjudicated 30-day computed tomography angiography, there were no Type 1a/1b or III endoleaks and 100% device patency. Median intensive care unit and hospital stays were 3.0 days (range, 1.0-13.0 days) and 7.0 days (range, 1.0-40.0 days).

Conclusions

The 30-day results from the TRIOMPHE IDE study primary statistical cohort support the hypothesis that high-risk aortic arch dissection patients can be successfully treated using an off-the-shelf branched stent graft system, obviating the need for sternotomy or hypothermic arrest with open repair.

Rights

© 2026 The Authors. 

This is an open access article under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) License.

Original Publication Citation

Leshnower, B. G., Panneton, J., Patel, H. J., Beck, A. W., Wooster, M., Eudailey, K. W., Fukuhara, S., Cho, J., Zeigler, S., Ohman, W., Kachroo, P., Brinster, D., Toursavadkohi, S., Ghoreishi, M., Taylor, B., Arko, F., Hayes, P., & Milner, R. (2026). Endovascular arch repair using a novel single branch arch stent graft: 30-day results from the chronic dissection arm of the nexus aortic arch clinical study to evaluate safety and effectiveness investigational device exemption study. JTCVS Structural and Endovascular, 10, Article 100113. https://doi.org/10.1016/j.xjse.2026.100113

Repository Citation

Leshnower, B. G., Panneton, J., Patel, H. J., Beck, A. W., Wooster, M., Eudailey, K. W., Fukuhara, S., Cho, J., Zeigler, S., Ohman, W., Kachroo, P., Brinster, D., Toursavadkohi, S., Ghoreishi, M., Taylor, B., Arko, F., Hayes, P., & Milner, R. (2026). Endovascular arch repair using a novel single branch arch stent graft: 30-day results from the chronic dissection arm of the nexus aortic arch clinical study to evaluate safety and effectiveness investigational device exemption study. JTCVS Structural and Endovascular, 10, Article 100113. https://doi.org/10.1016/j.xjse.2026.100113