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ACTIVE NOT RECRUITING
NCT05192616

Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease

Sponsor: iVascular S.L.U.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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