iliCo study: safety and effectiveness assessment of iCover balloon-expandable covered stent for the treatment of the iliac Occlusive Disease. Study protocol for a prospective, multicenter, single-arm, observational clinical investigation.

<title>Abstract</title> <p>Purpose: Development of new technologies and the performance of covered stents have led to increased use of endovascular therapy for extensive iliac steno-occlusive disease. The aim of the iliCo study is to evaluate the efficacy and the safety of the iCover balloon-expandable covered stent (CS) for the treatment of de novo iliac steno-occlusive disease in patient with symptomatic peripheral artery disease. Materials and Methods: The proposed study is a prospective, international, multicenter, observational study to evaluate iCover CS for the treatment of iliac steno-occlusive disease. Patients with symptomatic (Rutherford category 2 to 5) de novo atherosclerotic lesions of iliac segment will be included in the study. Two lesions cohorts will be stratified according to Trans Atlantic Inter Society Committee (TASC) class A and B versus C and D lesions. The primary endpoint of the study is the primary patency at 12 months. Secondary endpoints are safety of the iCover (general complications and major local complications), major amputation, primary sustained clinical improvement, target lesion revascularization, target vessel revascularization, and quality of life. Conclusion: CS may significantly increase the safety and efficacy of endovascular treatment for iliac steno-occlusive disease. The iliCo trial is expected to provide according data and set a benchmark for future randomized controlled trials comparing CS with bare metal stents in the treatment of iliac steno-occlusive disease . Trial registration: Registered in ClinicalTrials.gov (NCT05192616) the 13th of December, 2022.</p>