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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsoriVascular S.L.U.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients contraindicated for anti-platelet therapy.

Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia.

Chronic or acute aortic dissection.

Patients refusing treatment.

Trial design

Treatments tested in this trial

  • iCover balloon-expandable covered peripheral stent system as bridging stent

Treatment groups

165 Participants
are divided into 1 treatment group

Sponsors and collaborators