Actively Recruiting
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
Led by iVascular S.L.U. · Updated on 2026-04-14
165
Participants Needed
24
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient suitable for juxta, para-renal, suprarenal, or thoracoabdominal aneurysm treatment with fenestrated endoprosthesis per current guidelines (aneurysm >5 cm for women, >5.5 cm for men, or significant growth).
- Fenestrated endograft must position fenestrations within 5 mm of target vessel orifice.
- Anatomy and patient must match Instructions For Use of selected fenestrated endograft (Cook Medical, Terumo Aortic, JOTEC-Artivion).
- Up to two iCover stents may be used as bridging stents per target artery.
- Landing zone in target vessel of at least 10 mm.
- Target arteries (renal, superior mesenteric, celiac trunk) diameter between 5 and 10 mm.
- Aortic angulation at target vessels less than 45 degrees.
- No early significant branching from target vessel risking organ infarction.
- Age over 55 years.
- Patient consents and agrees to follow-up evaluations as specified.
- Patient is affiliated with or benefits from a social security system.
- Patient has life expectancy greater than 12 months.
You will not qualify if you...
- Contraindication to anti-platelet therapy.
- Uncontrolled blood disorders or heparin-induced thrombocytopenia.
- Chronic or acute aortic dissection.
- Refusal of treatment.
- Pregnancy or desire to become pregnant.
- Scheduled major or life-saving surgery within 30 days of procedure.
- Hemodynamically unstable or emergency treatment required.
- Severe arteriopathy impairing stent patency.
- Thrombus thicker than 3 mm in aortic sealing zone or target arteries.
- Stenosis over 50% or occlusion of target arteries or poor outflow.
- Allergy to stent materials (L605) or PTFE.
- Need for hybrid aortic techniques with branches, semibranches, or chimneys.
- Prior implantation of non-iCover stents as bridging stents in target arteries.
- Infectious or mycotic aneurysms.
- Renal artery angulation less than 30 degrees.
- Complex iliac access outside IFUs of fenestrated endograft with iCover.
- Participation in other investigational studies that may interfere.
- Myocardial infarction or stroke within 3 months prior.
- Unstable angina or heart failure NYHA class 3 or 4.
- ASA classification 5 or higher.
- Use of physician-modified endografts or in situ laser FEVAR.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 24 locations
1
Imelda Ziekenhuis
Bonheiden, Belgium, 2820
Not Yet Recruiting
2
ZOL GENK
Genk, Belgium, 3600
Not Yet Recruiting
3
Maria Middelares GENT
Ghent, Belgium, 9000
Not Yet Recruiting
4
UZ GENT
Ghent, Belgium, 9000
Not Yet Recruiting
5
Grand hopital Saint Josep
Gilly, Belgium, 6060
Not Yet Recruiting
6
Jessa Hasselt
Hasselt, Belgium, 3800
Not Yet Recruiting
7
Chu Liege
Liège, Belgium, B-4000
Not Yet Recruiting
8
CHU BORDEAUX-Hopital Tripode
Bordeaux, France, 33076
Actively Recruiting
9
CHU BREST- la Cavale Blanche
Brest, France, 29200
Not Yet Recruiting
10
CHU LILLE- Institut Cœur Poumon
Lille, France, 59000
Not Yet Recruiting
11
APHM- Hôpital De La Timone
Marseille, France, 13005
Not Yet Recruiting
12
Hôpital St Joseph
Marseille, France, 13008
Not Yet Recruiting
13
Nouvel Hôpital Privé les Franciscaines
Nîmes, France, 30000
Not Yet Recruiting
14
CHU TOULOUSE- Hôpital Rangueil
Toulouse, France, 31400
Not Yet Recruiting
15
Hôpital privé de Villeneuve d'Ascq
Villeneuve-d'Ascq, France, 59650
Not Yet Recruiting
16
University Hospital Cologne
Cologne, Germany, 50937
Not Yet Recruiting
17
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Not Yet Recruiting
18
Universitätsklinik Hamburg Eppendorf
Hamburg, Germany, 20246
Not Yet Recruiting
19
Uni-Klinikum Leipzig
Leipzig, Germany, 04103
Not Yet Recruiting
20
LMU München Campus Großhadern
München, Germany, 81377
Not Yet Recruiting
21
TUM Munich
München, Germany, 81675
Not Yet Recruiting
22
Amsterdam UMC
Amsterdam, Netherlands, 1105
Not Yet Recruiting
23
University Medical Center Groningen
Groningen, Netherlands, 9700
Not Yet Recruiting
24
Hospital Clinic - University of Barcelona
Barcelona, Spain, 08036
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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