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Complex Abdominal Aortic AneurysmsfenCoNCT07529275

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

A study testing iCover balloon-expandable covered peripheral stent system as bridging stent in people with Complex Abdominal Aortic Aneurysms, run by iVascular S.L.U. at 24 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Complex Abdominal Aortic Aneurysms
What is being tested?
iCover balloon-expandable covered peripheral stent system as bridging stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
24 sitesin 5 countries
Study dates
16 Feb 2026to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • 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.
  • Myocardial infarction or stroke within 3 months prior to the procedure.
  • Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4.
  • Patients with ASA classification 5 or higher.
  • Patients with physician modified endografts or in situ laser FEVAR.

Trial locations and contacts

24 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

24 sites in 5 countries

France8 sites, 8 recruiting

  • CHU BORDEAUX-Hopital Tripode

    Bordeaux, 33076

    Eric Prof. DUCASSE, 936724711 ext. +34, clinica@ivascular.global

    Recruiting

  • CHU BREST- la Cavale Blanche

    Brest, 29200

    Bahaa Prof. NASR, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • CHU LILLE- Institut Cœur Poumon

    Lille, 59000

    Jonathan Prof. SOBOCINSKI, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • APHM- Hôpital De La Timone

    Marseille, 13005

    Virgile Dr. OMNES, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • Hôpital St Joseph

    Marseille, 13008

    Nicolas Dr. VALIERO, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • Nouvel Hôpital Privé les Franciscaines

    Nîmes, 30000

    Nicolas Dr. LOUIS, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • CHU TOULOUSE- Hôpital Rangueil

    Toulouse, 31400

    Xavier Prof. CHAUFOUR, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • Hôpital privé de Villeneuve d'Ascq

    Villeneuve-d'Ascq, 59650

    Martin Dr ROUER, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

Other trials in France

Belgium7 sites, 7 recruiting

  • Imelda Ziekenhuis

    Bonheiden, 2820

    Wouter Dr. VAN DEN EYNDE, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • ZOL GENK

    Genk, 3600

    Wouter Dr. LANSINK, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • Maria Middelares GENT

    Ghent, 9000

    Willem Dr. WILLAERT, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • UZ GENT

    Ghent, 9000

    Natalie Dr. MOREELS, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • Grand hopital Saint Josep

    Gilly, 6060

    Philippe Dr. REMY, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • Jessa Hasselt

    Hasselt, 3800

    Frederic Dr. LIEBEER, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • Chu Liege

    Liège, B-4000

    Arnaud Dr KERZMANN, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

Other trials in Belgium

Germany6 sites, 6 recruiting

  • University Hospital Cologne

    Cologne, 50937

    Bernhard Prof. DORWEILER, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • Asklepios Klinik St. Georg

    Hamburg, 20099

    Thomas Prof. KOEPPEL, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • Universitätsklinik Hamburg Eppendorf

    Hamburg, 20246

    Tilo Prof. KOELBEL, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • Uni-Klinikum Leipzig

    Leipzig, 04103

    Andrej Prof. SCHMIDT, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • LMU München Campus Großhadern

    München, 81377

    Nikolaos Prof. TSILIMPARIS, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • TUM Munich

    München, 81675

    Daniela Dr BRANZAN, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

Other trials in Germany

Netherlands2 sites, 2 recruiting

  • Amsterdam UMC

    Amsterdam, 1105

    Vincent Dr.JONGKIND, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

  • University Medical Center Groningen

    Groningen, 9700

    Jean-Paul Dr. DE VRIES, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

Other trials in Netherlands

Spain1 site, 1 recruiting

  • Hospital Clinic - University of Barcelona

    Barcelona, 08036

    Viçenc Prof. RIAMBAU, 936724711 ext. +34, clinica@ivascular.global

    Not yet recruiting

Other trials in Spain

About this study

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.

Read the 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.

Being tested
iCover balloon-expandable covered peripheral stent system as bridging stent
Keywords
FEVAR, bridging stent, complex abdominal aortic aneurysms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT07529275
Study groupRoleWhat they receive
iCover balloon-expandable covered peripheral stent systemExperimentaliCover balloon-expandable covered peripheral stent system
Receives: Device: iCover balloon-expandable covered peripheral stent system as bridging stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 months visit

  2. 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).

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

Secondary outcomes (15)

  1. 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.

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

  2. 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.

    Measured: 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)

  3. 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.

    Measured: discharge visit , 6 and 12 months visits.

  4. 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.

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

  5. 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.

    Measured: discharge visit, 6 and 12 months visits.

  6. 30-day post-procedure mortality.

    Defined as rate of post-procedure mortality (all causes) within 30-day post procedure.

    Measured: within 30 days post procedure

  7. In-hospital post-procedure mortality (all causes).

    Defined as rate of In-hospital post-procedure mortality (all causes).

    Measured: between procedure and 12 months visit

  8. 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.

    Measured: at 6 and 12 months visits

  9. 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.

    Measured: at 6 and 12 months visits

  10. 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

    Measured: between implant and 6 and 12 months visits

  11. 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.

    Measured: between implant and 6 and 12 months visits

  12. 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.

    Measured: between implant 6 and 12 months visits.

  13. 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.

    Measured: between implant and 6, 12 months vists.

  14. Absence of target vessel instability at 12 months visit.

    Absence of target vessel instability at 12 months visit.

    Measured: at 12 months visit

  15. Target vessel patency at at 6 and 12 months visits

    Defined as proportion of target vessel patency at 6 and 12 months.

    Measured: 6 and 12 months visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start16 Feb 2026
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07529275
Sponsor's protocol ID
FenCo-01
Acronym
fenCo
Status last verified
Apr 2026
First submitted
26 Feb 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing iCover balloon-expandable covered peripheral stent system as bridging stent in people with Complex Abdominal Aortic Aneurysms, run by iVascular S.L.U. at 24 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France, Belgium, Germany, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bridging stent patency at 12-month visit (time frame: 12 months visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07529275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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