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.
Cook Medical: Zenith Fenestrated AAA Endovascular Graft
Terumo Aortic: TREO and Anaconda Fenestrated Stent Grafts
Patients contraindicated for anti-platelet therapy.
Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia.
Chronic or acute aortic dissection.
Patients refusing treatment.
Single group
iCover balloon-expandable covered peripheral stent system as bridging stent
DeviceThis device will be used as bridging stent during FEVAR (fenestrated endovascular aortic repair) procedures.
Bridging stent patency at 12-month visit
Defined as rate of stents with an absence of binary restenosis (≥ 50% stenosis) based on CT Angio at 12 months visit (+/-2 months).
Absence of target vessel instability between implantation and 12-month visit.
Defined as rate of patients with an absence of target vessel instability described as a composite endpoint of any branch-related complication leading to: aneurysm rupture/ death/ occlusion/ component separation/ or reintervention to maintain branch patency or to treat a branch-related component separation or endoleak between implantation and 12 months visit (+/-2 months).
Technical success: Successful introduction and deployment of the iCover stent implanted as bridging stent in FEVAR procedure.
Defined as rate of stents with successful introduction and deployment of the iCover (iVascular) implanted as bridging stent in FEVAR.
Bridging stent patency at the first postoperative imaging, at 6 and at 12 months visits.
Defined as rate of stents without binary restenosis \> 50% or occlusion on duplex scan and/or angioCT scan examination, or angiography at discharge at 6 and 12 months visits.
Absence of endoleaks linked to iCover covered stent defects at the first postoperative imaging, at 6 and 12 months visits.
Defined as rate of stents without endoleaks linked to iCover covered stent defects (Malposition, rupture or disconnection) on Duplex scan, angio CTscan or angiography at discharge visit, at 6 months visits and at 12 months visit.
Absence of re-intervention due to a technical defect in iCover covered stents at discharge, at 6 months visit, and at 12 months visit.
Defined as rate of stents without re-intervention due to a technical defect in iCover covered stents post-procedure between surgery and post operative to discharge period, between surgery and 6 months visit, between surgery and 12 months visit.
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