Gore Begins Pivotal Study in Aortoiliac Aneurysmal Disease

Oct. 1, 2026 — W. L. Gore & Associates’ medical business (Gore) has announced the first patient enrollment in the IBE Plus Pivotal Study, a clinical trial evaluating the investigational Gore Excluder IBE Plus Stent Graft for the treatment of aortoiliac and common iliac artery aneurysms. The first patients were implanted by Shahab Toursavadkohi, MD, National Principal Investigator at the University of Maryland and Aleem Mirza, MD, Principal Investigator at Orlando Regional Healthcare System.

Every year, 200,000 people in the U.S. are diagnosed with an abdominal aortic aneurysm (AAA), with up to 28% of AAAs extending into the iliac arteries. Despite evolving technology, existing iliac branch devices have limitations in their anatomic suitability to treat all patients.^1,2

IBE Plus Pivotal Study

The IBE Plus Clinical Trial is a prospective, nonrandomized, multicenter, interventional trial designed to evaluate the safety and effectiveness of the Gore Excluder IBE Plus Stent Graft in the endovascular treatment of aortoiliac and common iliac artery aneurysms. The study plans to enroll patients in two study arms at approximately 30 sites in the United States, with follow-up through 5 years.

“The initiation of this pivotal study is an exciting step forward for patients with aortoiliac aneurysmal disease,” said Shahab Toursavadkohi, MD, National Principal Investigator from the University of Maryland. “Maintaining internal iliac artery perfusion remains a key consideration in treatment planning. This study is an important milestone in the development of treatments to potentially expand iliac branch repair for more patients.”

“Aortoiliac aneurysmal disease can present unique treatment planning considerations, making continued clinical research especially important,” said Dr. Mirza. “We are excited to participate in this study and contribute to the clinical evidence being generated.”

Advancing Iliac Branch Innovation

“Clinical research is essential to advancing endovascular treatment options,” said Jill Paine, Product and Innovation Leader at Gore. “Science, engineering, and clinical evidence have long been the foundation of our innovation. The IBE Plus Pivotal Study reflects our ongoing commitment to partner with physicians and address unmet patient needs.”

Additional information about the study is available at https://clinicaltrials.gov/study/NCT07304102

1. Abdominal aortic aneurysm. Society for Vascular Surgery. Accessed July 23, 2026. https://vascular.org/your-vascular-health/vascular-conditions/common-conditions/abdominal-aortic-aneurysm

2. Gouveia E Melo R, Fenelli C, Fernández Prendes C, et al. A cross-sectional study on the anatomic feasibility of iliac side branch grafts in a real-world setting. J Vasc Surg. 2022;76(3):724-732. doi:10.1016/j.jvs.2022.02.056