Clinical Performance and Safety Assessment of the Use of iCover Balloon Expandable Covered Stent (iVascular) Implanted as Bridging Stent in FEVAR (Fenestrated Endovascular Aortic Repair) for the Treatment of Complex Abdominal Aortic Aneurysms
fenCo is a European multicentre, prospective study to evaluate the use of the iCover covered stents as bridging stents for reno-visceral target vessel during fEVAR for the treatment of complex abdominal aortic aneurysms.
• Patient suitable for treatment of a juxta, para-renal, suprarenal or thoracoabdominal aneurysm with a fenestrated endoprosthesis in accordance with current indications and guidelines for the management of abdominal aortic aneurysms (aneurysm \> 5 centimetres for women and \> 5.5 centimetres for men and/or growth \> 5 mm in 6 months or 1 centimetre in 1 year).
• The fenestrated endograft must be designed in a way that positions the fenestrations directly in front of the orifice of the target vessel, ensuring that the distance between the fenestration and the orifice of the target vessel does not exceed 5 mm.
• Anatomy and patient strictly in accordance with the Instructions For Use (IFU) of the fenestrated endograft chosen to be implanted:
∙ Cook Medical: Zenith Fenestrated AAA Endovascular Graft
‣ Terumo Aortic: TREO and Anaconda Fenestrated Stent Grafts
‣ JOTEC (part of Artivion): E-xtra design engineering.
• Additional iCover stent, if necessary, could be placed in the same target artery (2 iCovers stents max as bridging stent for each fenestration).
• Landing zone in the target vessel of at least 10 mm.
• Target arteries (renal arteries, superior mesenteric artery, celiac trunk) with a diameter between 5 and 10 mm.
• Angulation of the aorta at the level of the target vessels \< 45 degrees.
• No early significant branching from the target vessel with a potential risk of coverage and subsequent significant risk of target organ infarctions.
• Age \> 55 years.
⁃ Patient having notified his consent to this study and willing to comply with specified follow-up evaluations at the specified times.
⁃ Patient affiliated to or benefiting from a social security system.
⁃ Patient with life expectancy \> 12 months.