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Studies

Interventional Recruiting

NCT07529275 on ClinicalTrials.gov

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

  • Sponsor: iVascular S.L.U.
  • Enrollment: 165 (Estimated)
  • Study start: 2026-02-16 (Actual)
  • Primary completion: 2028-06-30 (Estimated)
  • Study completion: 2028-09-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

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

Primary Outcome Measures

  • Bridging stent patency at 12-month visit (12 months visit)
    Defined as rate of stents with an absence of binary restenosis (≥ 50% stenosis) based on CT Angio at 12 months visit (+/-2 months).
  • Absence of target vessel instability between implantation and 12-month visit. (starting at implant day through the study completion, with an average of 12Months up to 14Months per window.)
    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).

Countries

Belgium, France, Germany, Netherlands, Spain

Locations and Investigators

  • Imelda Ziekenhuis, Bonheiden, Belgium (Not yet recruiting)
    • Wouter Dr. VAN DEN EYNDE
  • ZOL GENK, Genk, Belgium (Not yet recruiting)
    • Wouter Dr. LANSINK
  • Maria Middelares GENT, Ghent, Belgium (Not yet recruiting)
    • Willem Dr. WILLAERT
  • UZ GENT, Ghent, Belgium (Not yet recruiting)
    • Natalie Dr. MOREELS
  • Grand hopital Saint Josep, Gilly, Belgium (Not yet recruiting)
    • Philippe Dr. REMY
  • Jessa Hasselt, Hasselt, Belgium (Not yet recruiting)
    • Frederic Dr. LIEBEER
  • Chu Liege, Liège, Belgium (Not yet recruiting)
    • Arnaud Dr KERZMANN
  • CHU BORDEAUX-Hopital Tripode, Bordeaux, France (Recruiting)
  • CHU BREST- la Cavale Blanche, Brest, France (Not yet recruiting)
    • Bahaa Prof. NASR
  • CHU LILLE- Institut CÅ“ur Poumon, Lille, France (Not yet recruiting)
  • APHM- Hôpital De La Timone, Marseille, France (Not yet recruiting)
    • Virgile Dr. OMNES
  • Hôpital St Joseph, Marseille, France (Not yet recruiting)
    • Nicolas Dr. VALIERO
  • Nouvel Hôpital Privé les Franciscaines, Nîmes, France (Not yet recruiting)
    • Nicolas Dr. LOUIS
  • CHU TOULOUSE- Hôpital Rangueil, Toulouse, France (Not yet recruiting)
    • Xavier Prof. CHAUFOUR
  • Hôpital privé de Villeneuve d'Ascq, Villeneuve-d'Ascq, France (Not yet recruiting)
    • Martin Dr ROUER
  • University Hospital Cologne, Cologne, Germany (Not yet recruiting)
    • Bernhard Prof. DORWEILER
  • Asklepios Klinik St. Georg, Hamburg, Germany (Not yet recruiting)
    • Thomas Prof. KOEPPEL
  • Universitätsklinik Hamburg Eppendorf, Hamburg, Germany (Not yet recruiting)
    • Tilo Prof. KOELBEL
  • Uni-Klinikum Leipzig, Leipzig, Germany (Not yet recruiting)
    • Andrej Prof. SCHMIDT
  • LMU München Campus Großhadern, München, Germany (Not yet recruiting)
    • Nikolaos Prof. TSILIMPARIS
  • TUM Munich, München, Germany (Not yet recruiting)
    • Daniela Dr BRANZAN
  • Amsterdam UMC, Amsterdam, Netherlands (Not yet recruiting)
    • Vincent Dr.JONGKIND
  • University Medical Center Groningen, Groningen, Netherlands (Not yet recruiting)
    • Jean-Paul Dr. DE VRIES
  • Hospital Clinic - University of Barcelona, Barcelona, Spain (Not yet recruiting)
    • Viçenc Prof. RIAMBAU