Rationale and design of a prospective European multicenter evaluation of the iCover balloon-expandable covered stent as a bridging stent in fenestrated endovascular aortic repair (fenCo).

内容摘要

Fenestrated endovascular aortic repair (FEVAR) is an established treatment for complex abdominal aortic aneurysms involving the renovisceral segment. Long-term durability remains dependent on bridging stent performance, yet prospective device-specific data remain limited. The fenCo study was designed to evaluate the clinical performance and safety of the iCover balloon-expandable covered stent (iVascular) used as a bridging stent during FEVAR. fenCo is a prospective, multicenter, open-label, single-arm European clinical investigation conducted in 24 high-volume centers under Regulation (EU) 2017/745. The study aims to include 165 patients undergoing FEVAR for juxtarenal, pararenal, suprarenal, or thoracoabdominal aneurysms using an IFU-compliant fenestrated endograft. All target vessels are bridged exclusively using the iCover balloon-expandable covered stent. Follow-up is planned at discharge, 6 months, and 12 months, with optional extension to 5 years. The primary efficacy endpoint is bridging-stent patency at 12 months, defined as absence of binary restenosis (≥50% stenosis) or occlusion on imaging. The primary safety endpoint is freedom from target vessel instability, defined as a composite of aneurysm rupture, target vessel occlusion, component separation, branch-related endoleak, or branch-related reintervention. Secondary endpoints include technical success, endoleaks, reinterventions, mortality, aneurysm sac evolution, and renal outcomes. fenCo will provide prospective multicenter European data on the safety and performance of the iCover stent used as a bridging stent during FEVAR using predefined imaging-based and clinically adjudicated endpoints. The study is expected to strengthen the evidence base for bridging stent selection in complex endovascular aortic repair.