RecruitingNot Applicable

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

Belgium165 participantsStarted 2026-02-16

Plain-language summary

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.

Who can participate

Age range55 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Patients contraindicated for anti-platelet therapy.
✕. Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia.
✕

What they're measuring

Bridging stent patency at 12-month visit

Timeframe: 12 months visit

Absence of target vessel instability between implantation and 12-month visit.

Timeframe: starting at implant day through the study completion, with an average of 12Months up to 14Months per window.

Trial details

NCT IDNCT07529275

SponsoriVascular S.L.U.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-30

View on ClinicalTrials.gov More Complex Abdominal Aortic Aneurysms trials