LB02 - Five year results of the United States regulatory (IDE) trial of an EVAR device specifically designed for treatment of patients with severely angulated aortic necks

Saturday, June 13, 2026

7:54 AM - 8:03 AM ET

Location: Hynes CC, Third Level, Ballroom A

Submitting & Presenting Author(s)

Robert Y. Rhee, MD (he/him/his)

Chief, Vascular Surgery
Maimonides Health
Brooklyn, New York

Co-Author(s)

Sukgu M. Han, MD, MS (he/him/his)

Professor of Surgery and Chief, Division of Vascular Surgery and Endovascular Therapy
Keck Medical Center of Univerisity of Southern California
Los Angeles, California
MA

Mahmoud Almadani
Dai Yamanouchi, MD, PhD (he/him/his)

Staff Vascular Surgeon and Professor of Vascular Surgery
University of Wisconsin School of Medicine, Division of Vascular Surgery
Madison, Wisconsin
MS

Mel J. Sharafuddin

Clinical Professor of Surgery
Memorial Hospital Central, University of Colorado Healthcare, 1400 E Boulder St, Colorado Springs, CO 80909
Colorado Springs, Colorado
Patrick Muck, MD

Chief, Vascular Surgery
Good Samaritan Hospital
Cincinnati, Ohio
Em

Erin M. moore, MD

Chief, Vascular Surgery
Baptist Hospital, Jascksonville
Jacksonville, Florida
Jon S. Matsumura, MD

University of Colarado
Silverthorne, Colorado
GO

Gustavo Oderich

Professor of surgery
Michael E. DeBakey Department of Surgery, Division of Vascular and Endovascular Surgery, Baylor College of Medicine, Houston, TX

Objectives: To report the 5-year clinical outcomes of the high neck angulation (HNA) substudy of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) for treatment of infrarenal abdominal aortic aneurysms (AAAs) in the US Regulatory IDE trial.

Methods: This prospective, multicenter clinical trial was conducted in the United States and included core laboratory assessment of imaging and independent event adjudication through the 5 year period. Primary safety and effectiveness end points were assessed at 1-year in a cohort of patients with AAA having infrarenal aortic neck angulation (HNA) > 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm. The 5 year results in patients in the Short Neck (SN) cohort has been previously reported and compared to results of the current substudy.

Results: Among 175 patients in the EXCC IDE study, 95 were enrolled in the HNA sub-study between January 22, 2018 – February 16, 2022. Patients were 74.7% (71/95) male with an average age of 74.4 years. At the time of this report there were 44 subjects eligible for follow-up at the beginning of 5-year window, 35 subjects had a 5 yr visit (33 subjects with imaging, of which 24 had CTA), 6 subjects missed the 5 yr visit, and 3 are currently pending their 5 yr visit. There have been 33 deaths reported (1 aneurysm related), 4 conversions to open repair, 1 rupture, and 22 lost to follow up. Freedom from Type II endoleaks was 38.2%, with no new type I or II endoleaks reported during years 2-5; no migration occurred at any time during the study. Aneurysm shrinkage >/=5mm occurred in 51.7%, 31% of patients had a stable aneurysm sac, and 17.2% experienced aneurysm growth >/=5mm, and at 5-years. Of those subjects with aneurysm growth, one subject was converted to open surgical repair and experienced aneurysm-related mortality. Overall freedom from aneurysm related mortality (96.9%) and endoleak rates were not significantly different than the SN cohort previously reported (Figures 1 & 2).

Conclusions: The US IDE study demonstrates durable safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis device in AAA implanted in patients with highly angulated aortic necks (>60 and ≤90°), sustained through 5 year follow-up.