Gore announced today the first patient enrolment in the IBE Plus pivotal study, a clinical trial evaluating the investigational Gore Excluder iliac branch endoprosthesis (IBE) Plus stent graft for the treatment of aortoiliac and common iliac artery aneurysms.
The first patients were implanted by Shahab Toursavadkohi, national principal investigator at the University of Maryland (College Park, USA), and Aleem Mirza, principal investigator at Orlando Regional Healthcare System (Orlando, USA).
Gore shares in a press release that the IBE Plus clinical study is a prospective, non-randomised, multicentre interventional trial. It plans to enrol patients in two study arms at approximately 30 sites in the USA, with follow-up through five years.
“The initiation of this pivotal study is an exciting step forward for patients with aortoiliac aneurysmal disease,” said Toursavadkohi. “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.”
Mirza added: “Aortoiliac aneurysmal disease can present unique treatment planning considerations, making continued clinical research especially important. We are excited to participate in this study and contribute to the clinical evidence being generated.”
