Evaluation of the iHub Endovascular Iliac Stent-Graft for Safe Treatment of Iliac Artery Aneurysms in Adults

What this Trial Is About

Researchers are evaluating the safety, performance, and preliminary effectiveness of the iHub endoprosthesis system in treating iliac artery aneurysms in adults who require endovascular repair. The study focuses on preserving blood flow to the internal iliac artery while excluding the aneurysm, addressing challenges in complex pelvic artery anatomy. This trial is a first-in-human, interventional clinical investigation designed to meet an important need for patients unsuitable for conventional treatments. Participants will undergo a minimally invasive procedure to implant the iHub stent-graft using a catheter-based delivery system guided by fluoroscopy. The device is designed to exclude aneurysms in the common iliac artery while preserving internal iliac artery perfusion. The study includes follow-up visits at 30, 90, 180, and 360 days post-implantation to evaluate device safety, accurate placement, and aneurysm exclusion. During the study, participants will have pre-screening evaluations including clinical exams, laboratory tests, and imaging such as CT angiography and ultrasound. Follow-up visits will assess clinical outcomes and device performance through physical exams, imaging, and laboratory tests. Researchers will monitor adverse events and device-related complications, focusing on serious adverse events within 30 days and device performance up to one year. The total participation time includes follow-up for 360 days after implantation.

iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study