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

NCT07529275 | Recruiting DMC

• 1 other identifier: FenCo-01
• Study Type: interventional
• Target: 165
• Locations: 5 countries
• Sites: 24

Brief 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.

Conditions

Complex Abdominal Aortic Aneurysms

Keywords

FEVAR; bridging stent; complex abdominal aortic aneurysms

Outcome Measures

Primary Outcomes (2)

• 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).

  12 months visit

• 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).

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

Secondary Outcomes (15)

• Technical success: Successful introduction and deployment of the iCover stent implanted as bridging stent in FEVAR procedure.

  During the index procedure (from stent introduction to final deployment, up to procedure completion)

• Bridging stent patency at the first postoperative imaging, at 6 and at 12 months visits.

  at discharge visit (up to 3 months, average of 7days) and at 6 and 12 months visits ( can be up to 8 and 14months from implant day)

• Absence of endoleaks linked to iCover covered stent defects at the first postoperative imaging, at 6 and 12 months visits.

  discharge visit , 6 and 12 months visits.

• Absence of re-intervention due to a technical defect in iCover covered stents at discharge, at 6 months visit, and at 12 months visit.

  between surgery and post operative to discharge period, between surgery and 6 months visit, between surgery and 12 months visit.

• Absence of type I or III endoleaks post-procedure at the first postoperative imaging, at 6 and 12 months visits.

  discharge visit, 6 and 12 months visits.

Study Arms (1)

iCover balloon-expandable covered peripheral stent system

EXPERIMENTAL

iCover balloon-expandable covered peripheral stent system

Device: iCover balloon-expandable covered peripheral stent system as bridging stent

Interventions

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

This device will be used as bridging stent during FEVAR (fenestrated endovascular aortic repair) procedures.

iCover balloon-expandable covered peripheral stent system

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients contraindicated for anti-platelet therapy.
• Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia.
• Chronic or acute aortic dissection.
• Patients refusing treatment.
• Patients who are pregnant or wish to become pregnant.
• Patients scheduled for major or life-saving surgery within 30 days of the fenestrated stent procedure.
• Patients considered hemodynamically unstable or requiring emergency treatment.
• Patients with severe arteriopathy leading to adverse outflow, which may impair bridging stent patency on the targeted artery.
• Thrombus in the aortic sealing zone and target arteries with thickness \> to 3 mm.
• Stenosis (\>50%) or occlusion of target arteries or distal disease resulting in poor iCover stent outflow.
• Patients allergic to stent materials (L605) and/or PTFE.
• Patients requiring a hybrid aortic technique with branches, semibranches or chimneys.
• Patient who has been implanted with any stent type or brand other than iCover as a bridging stent in any target artery.
• Patients with infectious/mycotic aneurysms.
• Angulation between renal artery and aortic wall \< 30 degrees.

Sponsors & Collaborators

• iVascular S.L.U.: lead

Study Sites (24)

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

NOT YET RECRUITING

ZOL GENK

Genk, 3600, Belgium

NOT YET RECRUITING

Maria Middelares GENT

Ghent, 9000, Belgium

NOT YET RECRUITING

UZ GENT

Ghent, 9000, Belgium

NOT YET RECRUITING

Grand hopital Saint Josep

Gilly, 6060, Belgium

NOT YET RECRUITING

Jessa Hasselt

Hasselt, 3800, Belgium

NOT YET RECRUITING

Chu Liege

Liège, B-4000, Belgium

NOT YET RECRUITING

CHU BORDEAUX-Hopital Tripode

Bordeaux, 33076, France

RECRUITING

CHU BREST- la Cavale Blanche

Brest, 29200, France

NOT YET RECRUITING

CHU LILLE- Institut Cœur Poumon

Lille, 59000, France

NOT YET RECRUITING

APHM- Hôpital De La Timone

Marseille, 13005, France

NOT YET RECRUITING

Hôpital St Joseph

Marseille, 13008, France

NOT YET RECRUITING

Nouvel Hôpital Privé les Franciscaines

Nîmes, 30000, France

NOT YET RECRUITING

CHU TOULOUSE- Hôpital Rangueil

Toulouse, 31400, France

NOT YET RECRUITING

Hôpital privé de Villeneuve d'Ascq

Villeneuve-d'Ascq, 59650, France

NOT YET RECRUITING

University Hospital Cologne

Cologne, 50937, Germany

NOT YET RECRUITING

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

NOT YET RECRUITING

Universitätsklinik Hamburg Eppendorf

Hamburg, 20246, Germany

NOT YET RECRUITING

Uni-Klinikum Leipzig

Leipzig, 04103, Germany

NOT YET RECRUITING

LMU München Campus Großhadern

München, 81377, Germany

NOT YET RECRUITING

TUM Munich

München, 81675, Germany

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, 1105, Netherlands

NOT YET RECRUITING

University Medical Center Groningen

Groningen, 9700, Netherlands

NOT YET RECRUITING

Hospital Clinic - University of Barcelona

Barcelona, 08036, Spain

NOT YET RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: April 14, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

BE (7); FR (8); NL (2); DE (6); ES (1)