The Journal of cardiovascular surgery · 2026
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).
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Ducasse Eric, Riambau Vincent, Tsilimparis Nikolaos, De Vries Jean-Paul, Lansink Wouter, Caradu Caroline, fenCo Investigators
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.