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 (fenCo)

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.

Study Overview

• Status: Recruiting
• Conditions: Complex Abdominal Aortic Aneurysms
• Intervention / Treatment: Device: iCover balloon-expandable covered peripheral stent system as bridging stent

Detailed Description

In terms of complex endovascular repair, fenestrated stent grafts should be considered the preferred treatment option when feasible. The main advantage of Fenestrated Endovascular Aneurysm Repair (fEVAR) lies in the avoidance of aortic cross clamping and subsequent lower risk of renal dysfunction, less surgical trauma and faster recovery, which may be advantageous for patients at high risk for open surgery. fenCo study aims to demonstrate the safety and efficacy of iCover when used as bridging stent in fEVAR procedures for the treatment of complex abdominal aortic aneurysms.

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Not yet recruiting
    • Imelda Ziekenhuis
    • Contact: Wouter Dr. VAN DEN EYNDE; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Genk, Belgium, 3600
    • Not yet recruiting
    • ZOL GENK
    • Contact: Wouter Dr. LANSINK; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • UZ Gent
    • Contact: Natalie Dr. MOREELS; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • Maria Middelares GENT
    • Contact: Willem Dr. WILLAERT; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Gilly, Belgium, 6060
    • Not yet recruiting
    • Grand hopital Saint Josep
    • Contact: Philippe Dr. REMY; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Hasselt, Belgium, 3800
    • Not yet recruiting
    • JESSA Hasselt
    • Contact: Frederic Dr. LIEBEER; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Liège, Belgium, B-4000
    • Not yet recruiting
    • Chu Liege
    • Contact: Arnaud Dr KERZMANN; Phone Number: +34 936724711; Email: clinica@ivascular.global
• France
  • Bordeaux, France, 33076
    • Recruiting
    • CHU BORDEAUX-Hopital Tripode
    • Contact: Eric Prof. DUCASSE; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Brest, France, 29200
    • Not yet recruiting
    • CHU BREST- la Cavale Blanche
    • Contact: Bahaa Prof. NASR; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Lille, France, 59000
    • Not yet recruiting
    • CHU LILLE- Institut Cœur Poumon
    • Contact: Jonathan Prof. SOBOCINSKI; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Marseille, France, 13005
    • Not yet recruiting
    • APHM- Hopital de la Timone
    • Contact: Virgile Dr. OMNES; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Marseille, France, 13008
    • Not yet recruiting
    • Hôpital St Joseph
    • Contact: Nicolas Dr. VALIERO; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Nîmes, France, 30000
    • Not yet recruiting
    • Nouvel Hôpital Privé les Franciscaines
    • Contact: Nicolas Dr. LOUIS; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Toulouse, France, 31400
    • Not yet recruiting
    • CHU TOULOUSE- Hôpital Rangueil
    • Contact: Xavier Prof. CHAUFOUR; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Villeneuve-d'Ascq, France, 59650
    • Not yet recruiting
    • Hopital Prive de Villeneuve d'Ascq
    • Contact: Martin Dr ROUER; Phone Number: +34 936724711; Email: clinica@ivascular.global
• Germany
  • Cologne, Germany, 50937
    • Not yet recruiting
    • University Hospital Cologne
    • Contact: Bernhard Prof. DORWEILER; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Hamburg, Germany, 20099
    • Not yet recruiting
    • Asklepios Klinik St. Georg
    • Contact: Thomas Prof. KOEPPEL; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Hamburg, Germany, 20246
    • Not yet recruiting
    • Universitätsklinik Hamburg Eppendorf
    • Contact: Tilo Prof. KOELBEL; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Leipzig, Germany, 04103
    • Not yet recruiting
    • Uni-Klinikum Leipzig
    • Contact: Andrej Prof. SCHMIDT; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • München, Germany, 81377
    • Not yet recruiting
    • LMU München Campus Großhadern
    • Contact: Nikolaos Prof. TSILIMPARIS; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • München, Germany, 81675
    • Not yet recruiting
    • TUM Munich
    • Contact: Daniela Dr BRANZAN; Phone Number: +34 936724711; Email: clinica@ivascular.global
• Netherlands
  • Amsterdam, Netherlands, 1105
    • Not yet recruiting
    • Amsterdam UMC
    • Contact: Vincent Dr.JONGKIND; Phone Number: +34 936724711; Email: clinica@ivascular.global
  • Groningen, Netherlands, 9700
    • Not yet recruiting
    • University Medical Center Groningen
    • Contact: Jean-Paul Dr. DE VRIES; Phone Number: +34 936724711; Email: clinica@ivascular.global
• Spain
  • Barcelona, Spain, 08036
    • Not yet recruiting
    • Hospital Clinic - University of Barcelona
    • Contact: Viçenc Prof. RIAMBAU; Phone Number: +34 936724711; Email: clinica@ivascular.global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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).
2. 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.

3. Anatomy and patient strictly in accordance with the Instructions For Use (IFU) of the fenestrated endograft chosen to be implanted:

   1. Cook Medical: Zenith Fenestrated AAA Endovascular Graft
   2. Terumo Aortic: TREO and Anaconda Fenestrated Stent Grafts
   3. JOTEC (part of Artivion): E-xtra design engineering.
4. Additional iCover stent, if necessary, could be placed in the same target artery (2 iCovers stents max as bridging stent for each fenestration).
5. Landing zone in the target vessel of at least 10 mm.
6. Target arteries (renal arteries, superior mesenteric artery, celiac trunk) with a diameter between 5 and 10 mm.
7. Angulation of the aorta at the level of the target vessels < 45 degrees.
8. No early significant branching from the target vessel with a potential risk of coverage and subsequent significant risk of target organ infarctions.
9. Age > 55 years.
10. Patient having notified his consent to this study and willing to comply with specified follow-up evaluations at the specified times.
11. Patient affiliated to or benefiting from a social security system.
12. Patient with life expectancy > 12 months.

Exclusion Criteria:

1. Patients contraindicated for anti-platelet therapy.
2. Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia.
3. Chronic or acute aortic dissection.
4. Patients refusing treatment.
5. Patients who are pregnant or wish to become pregnant.
6. Patients scheduled for major or life-saving surgery within 30 days of the fenestrated stent procedure.
7. Patients considered hemodynamically unstable or requiring emergency treatment.
8. Patients with severe arteriopathy leading to adverse outflow, which may impair bridging stent patency on the targeted artery.
9. Thrombus in the aortic sealing zone and target arteries with thickness > to 3 mm.
10. Stenosis (>50%) or occlusion of target arteries or distal disease resulting in poor iCover stent outflow.
11. Patients allergic to stent materials (L605) and/or PTFE.
12. Patients requiring a hybrid aortic technique with branches, semibranches or chimneys.
13. Patient who has been implanted with any stent type or brand other than iCover as a bridging stent in any target artery.
14. Patients with infectious/mycotic aneurysms.
15. Angulation between renal artery and aortic wall < 30 degrees.
16. Patients with complex iliac accesses out the IFUs of the fenestrated endograft chosen to be implanted (COOK Medical / Terumo Aortic/Jotec-Artivion) with the iCover Bridging stent.
17. Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period that may interfere with the results of this study.
18. Myocardial infarction or stroke within 3 months prior to the procedure.
19. Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4.
20. Patients with ASA classification 5 or higher.
21. Patients with physician modified endografts or in situ laser FEVAR.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iCover balloon-expandable covered peripheral stent system	Device: iCover balloon-expandable covered peripheral stent system as bridging stent; This device will be used as bridging stent during FEVAR (fenestrated endovascular aortic repair) procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Defined as rate of stents without type I or III endoleaks post-procedure on duplex scan, angio CTscan or angiography at discharge period, 6 months visit and at 12 months visit.	discharge visit, 6 and 12 months visits.
30-day post-procedure mortality.	Defined as rate of post-procedure mortality (all causes) within 30-day post procedure.	within 30 days post procedure
In-hospital post-procedure mortality (all causes).	Defined as rate of In-hospital post-procedure mortality (all causes).	between procedure and 12 months visit
Absence of aortic endograft migration at 6 months visit and at 12 months visit.	Defined as rate of endografts without aortic migration > 10 mm at 6 Months visit and 12 months visit.	at 6 and 12 months visits
No increase in maximum aneurysmal sac diameter measured by CT angiography at 6 and at 12 months visits.	Defined as rate of patients without increase of > 5 mm in maximum aneurysmal sac diameter compared with post-procedure angio CT scan measured by angio CT scan at 6 and 12 months visits.	at 6 and 12 months visits
Absence of post-procedural aortic surgical conversion at discharge, at 6 and 12 months visits.	Defined as absence of post-procedural aortic surgical conversion between the implantation and the follow-up visits	between implant and 6 and 12 months visits
Absence of aneurysm-related mortality post-procedure at discharge, at 6 months and 12 months visits.	Defined as absence of aneurysm-related mortality post-procedure between the implantation and the follow-up visits.	between implant and 6 and 12 months visits
Absence of aneurysm related secondary endovascular procedures at discharge, at 6 and 12 months visits.	Defined as absence of aneurysm related secondary endovascular procedures between the implantation and the follow-up visits.	between implant 6 and 12 months visits.
Absence of major adverse events (MAEs) at discharge, at 6 and 12 months visits.	Defined as aortic rupture, aneurysm-related death, in-hospital death, decline in renal function (by at least 20%), lower extremity ischemia, mesenteric ischemia, or unplanned reintervention between the implantation and the follow-up visits.	between implant and 6, 12 months vists.
Absence of target vessel instability at 12 months visit.	Absence of target vessel instability at 12 months visit.	at 12 months visit
Target vessel patency at at 6 and 12 months visits	Defined as proportion of target vessel patency at 6 and 12 months.	6 and 12 months visits

Collaborators and Investigators

• Sponsor: iVascular S.L.U.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: FEVAR; bridging stent; complex abdominal aortic aneurysms
• Other Study ID Numbers: FenCo-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No