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Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease
Sponsor: iVascular S.L.U.
Summary
The objective of this prospective, multi-center, non-randomized, single-arm observational study is to evaluate the safety and the efficacy of the iCover covered stent over a 24-month follow-up period for the treatment of de novo iliac occlusive lesions, defined by a significant vessel stenosis ≥70%, in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).
Official title: Prospective, Multicenter, Non-randomized, Single-arm Observational Study to Evaluate Safety and Effectiveness of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
241
Start Date
2022-04-27
Completion Date
2026-06
Last Updated
2025-05-16
Healthy Volunteers
No
Conditions
Interventions
Covered stent implantation
Percutaneous transluminal angioplasty (PTA) with iCover covered stent for the treatment of de novo aorto-iliac occlusive lesions
Locations (18)
Onze Lieve Vrouw Aalst
Aalst, Belgium
Imelda Bonheiden
Bonheiden, Belgium
Az Sint Blasius Dendermonde
Dendermonde, Belgium
ZOL Genk
Genk, Belgium
Centre Hospitalier Universitaire de Brest
Brest, France
CHU Pitié Salpêtrière
Paris, France
Hôpital Paris Saint Joseph
Paris, France
Hôpital privé Saint-Martin
Pessac, France
Hôpital privé Villeneuve d'Ascq
Villeneuve-d'Ascq, France
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany
MVZ Kaiserslautern
Kaiserslautern, Rhineland-Palatinate, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
KEH Berlin
Berlin, Germany
Imland Klinik Rendsburg
Rendsburg, Germany
Hospital de Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain
Hospital de Cruces
Bilbao, Spain
Hospital Parc Taulí
Sabadell, Spain